Trial Outcomes & Findings for Stimulating Language in Subacute StrokE (NCT NCT02674490)
NCT ID: NCT02674490
Last Updated: 2023-03-10
Results Overview
The purpose of this measure was to determine whether A-tDCS coupled with SALT will improve naming performance of participants with post stroke aphasia more effectively than SALT alone (i.e., the sham condition). The PNT is a 175-item picture naming test where a person earns one point per each correct answer. Scores range from 0-175 with higher scores associated with better performance. The outcome measure was the difference between the average of administrations on two consecutive days immediately before treatment and administrations on two consecutive days within 1 week after the end of treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
2 consecutive days immediately before treatment and 2 consecutive days within 1 week after the end of treatment
Results posted on
2023-03-10
Participant Flow
Participant milestones
| Measure |
A-tDCS & SALT
A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. The electrical current will be administered to a pre-specified region of the brain. The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes. SALT will be a computer-delivered naming + picture matching task .
A-tDCS (1 mA): 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
|
Sham-tDCS & SALT
Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SALT will be a computer delivered oral naming + picture naming task.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
Sham: 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
28
|
|
Overall Study
Received at Least One Treatment Session (Modified Intent-to-treat Sample)
|
26
|
25
|
|
Overall Study
COMPLETED
|
25
|
21
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stimulating Language in Subacute StrokE
Baseline characteristics by cohort
| Measure |
A-tDCS & SALT
n=26 Participants
A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. The electrical current will be administered to a pre-specified region of the brain. The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes. SALT will be a computer-delivered naming + picture matching task .
A-tDCS (1 mA): 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
|
Sham-tDCS & SALT
n=25 Participants
Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SALT will be a computer delivered oral naming + picture naming task.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
Sham: 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
63.8 years
STANDARD_DEVIATION 15 • n=7 Participants
|
64.5 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
19 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Western Aphasia Battery Aphasia Quotient
|
68.9 units on a scale
n=5 Participants
|
59.9 units on a scale
n=7 Participants
|
66.1 units on a scale
n=5 Participants
|
|
NIH Stroke Scale
|
2 units on a scale
n=5 Participants
|
5 units on a scale
n=7 Participants
|
4 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 consecutive days immediately before treatment and 2 consecutive days within 1 week after the end of treatmentPopulation: The mITT=modified Intent-to-treat sample is defined as all randomized participants for whom study treatment was initiated (e.g. attended at least one treatment session), regardless of the treatment actually received. Participants were analyzed according to the group to which they were randomized. Missing data was imputed using multiple imputation. The primary analysis was adjusted for aphasia type (Anomia, Broca, or other type), baseline aphasia severity (AQ), and age.
The purpose of this measure was to determine whether A-tDCS coupled with SALT will improve naming performance of participants with post stroke aphasia more effectively than SALT alone (i.e., the sham condition). The PNT is a 175-item picture naming test where a person earns one point per each correct answer. Scores range from 0-175 with higher scores associated with better performance. The outcome measure was the difference between the average of administrations on two consecutive days immediately before treatment and administrations on two consecutive days within 1 week after the end of treatment.
Outcome measures
| Measure |
A-tDCS & SALT
n=26 Participants
A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. The electrical current will be administered to a pre-specified region of the brain. The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes. SALT will be a computer-delivered naming + picture matching task .
A-tDCS (1 mA): 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
|
Sham-tDCS & SALT
n=25 Participants
Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SALT will be a computer delivered oral naming + picture naming task.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
Sham: 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
|
|---|---|---|
|
Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test (PNT)) Pre-treatment to 1 Week Post-treatment
|
22.3 score on a scale
Interval 13.5 to 31.2
|
18.5 score on a scale
Interval 9.6 to 27.4
|
SECONDARY outcome
Timeframe: The PNT will be administered at baseline and at 5 weeks post treatment.Population: Completers sample. Missing data is not imputed. Data was missing for 6 participants.
To determine whether A-tDCS coupled with SALT will improve naming performance of participants with post stroke aphasia for a greater duration than SALT alone (i.e., the sham condition). The PNT is a 175-item picture naming test where a person earns one point per each correct answer. Scores range from 0-175 with higher scores associated with better performance.
Outcome measures
| Measure |
A-tDCS & SALT
n=25 Participants
A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. The electrical current will be administered to a pre-specified region of the brain. The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes. SALT will be a computer-delivered naming + picture matching task .
A-tDCS (1 mA): 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
|
Sham-tDCS & SALT
n=20 Participants
Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SALT will be a computer delivered oral naming + picture naming task.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
Sham: 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
|
|---|---|---|
|
Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test) Pre-treatment to 5-weeks Post-treatment
|
29.95 score on a scale
Interval 18.84 to 41.07
|
20.82 score on a scale
Interval 9.36 to 32.27
|
SECONDARY outcome
Timeframe: Immediately before and within 1 week after treatmentPopulation: Completers sample. Missing data is not imputed. The data was missing for 9 patients.
The investigators will also record the description of the "Cookie Theft" picture during administration of the National Institutes of Health Stroke Scale before and after treatment, and count the number of Content Units (CU) mentioned by healthy controls. This measure provides a sensitive measure of content of narrative speech in all levels of aphasia. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance.
Outcome measures
| Measure |
A-tDCS & SALT
n=25 Participants
A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. The electrical current will be administered to a pre-specified region of the brain. The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes. SALT will be a computer-delivered naming + picture matching task .
A-tDCS (1 mA): 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
|
Sham-tDCS & SALT
n=17 Participants
Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SALT will be a computer delivered oral naming + picture naming task.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
Sham: 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
|
|---|---|---|
|
Change in Content of Picture Description Pre-treatment to 1 Week Post-treatment
|
4.10 units on a scale
Interval 1.93 to 6.27
|
1.66 units on a scale
Interval -0.89 to 4.21
|
SECONDARY outcome
Timeframe: Immediately before and within 1 week after treatmentPopulation: Completers sample. Missing data is not imputed. The data was missing for 9 patients.
The investigators determined the number of syllables/content unit (CU) in the Cookie Theft description, then calculated the difference between this performance pre-treatment and 1-week post-treatment. Syllables/CU provides a sensitive measure of efficiency of narrative speech in all levels of aphasia. Greater efficiency (fewer syllables required to convey a given amount of content) is associated with improvement in language. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance. A person who does not produce any language would have zero syllables, but there is no maximum number of syllables a person is allowed to produce in response to the task.
Outcome measures
| Measure |
A-tDCS & SALT
n=25 Participants
A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. The electrical current will be administered to a pre-specified region of the brain. The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes. SALT will be a computer-delivered naming + picture matching task .
A-tDCS (1 mA): 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
|
Sham-tDCS & SALT
n=17 Participants
Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SALT will be a computer delivered oral naming + picture naming task.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
Sham: 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
|
|---|---|---|
|
Change in Efficiency of Picture Description Pre-treatment to 1 Week Post-treatment
|
-12.23 units on a scale
Interval -19.99 to -4.46
|
-1.29 units on a scale
Interval -11.42 to 8.83
|
SECONDARY outcome
Timeframe: Immediately before and at 5 weeks after treatmentPopulation: Completers sample. Missing data is not imputed. The data was missing for 10 patients.
The investigators will also record the description of the "Cookie Theft" picture during administration of the National Institutes of Health Stroke Scale before and after treatment, and count the number of Content Units (CU) mentioned by healthy controls. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance.
Outcome measures
| Measure |
A-tDCS & SALT
n=24 Participants
A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. The electrical current will be administered to a pre-specified region of the brain. The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes. SALT will be a computer-delivered naming + picture matching task .
A-tDCS (1 mA): 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
|
Sham-tDCS & SALT
n=17 Participants
Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SALT will be a computer delivered oral naming + picture naming task.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
Sham: 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
|
|---|---|---|
|
Change in Content of Picture Description Pre-treatment to 5 Weeks Post-treatment
|
5.42 units on a scale
Interval 3.22 to 7.62
|
1.42 units on a scale
Interval -1.14 to 3.97
|
SECONDARY outcome
Timeframe: Immediately before and at 5 weeks after treatmentPopulation: Completers sample. Missing data is not imputed. The data was missing for 10 patients.
The investigators determined the number of syllables/content unit (CU) in the Cookie Theft description, then calculated the difference between this performance pre-treatment and 5-weeks post-treatment. Syllables/CU provides a sensitive measure of efficiency of narrative speech in all levels of aphasia. Greater efficiency (fewer syllables required to convey a given amount of content) is associated with improvement in language. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance. A person who does not produce any language would have zero syllables, but there is no maximum number of syllables a person is allowed to produce in response to the task.
Outcome measures
| Measure |
A-tDCS & SALT
n=24 Participants
A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. The electrical current will be administered to a pre-specified region of the brain. The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes. SALT will be a computer-delivered naming + picture matching task .
A-tDCS (1 mA): 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
|
Sham-tDCS & SALT
n=17 Participants
Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SALT will be a computer delivered oral naming + picture naming task.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
Sham: 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
|
|---|---|---|
|
Change in Efficiency of Picture Description Pre-treatment to 5 Weeks Post-treatment
|
-12.64 units on a scale
Interval -20.46 to -4.82
|
2.47 units on a scale
Interval -7.48 to 12.43
|
SECONDARY outcome
Timeframe: Immediately before and within 1 week after treatmentPopulation: Completers sample. Missing data is not imputed. The data was missing for 9 patients.
The SIS will be administered at baseline and within 1 week after treatment to evaluate changes in quality of life and social engagement. The SIS includes 59 aspects of post-stroke functioning. Participants rate each of the items on a scale from 5 (least encumbered, affected, or difficult) to 1 (most encumbered, affected or difficult). Ratings on each aspect are summed and then transformed to a 100-point scale using the following formula: Score = \[(Actual raw score - lowest possible raw score) / Possible raw score range\] x 100 The last item (#60) assesses the participant's overall perception of recovery and is presented in the form of a visual analog scale from 0 to 100, where 0 = "no recovery" and 100 = "full recovery." Total score is the average of all transformed scores and the overall perception of recovery. Total scores range from 0-100, with higher scores associated with better recovery.
Outcome measures
| Measure |
A-tDCS & SALT
n=22 Participants
A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. The electrical current will be administered to a pre-specified region of the brain. The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes. SALT will be a computer-delivered naming + picture matching task .
A-tDCS (1 mA): 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
|
Sham-tDCS & SALT
n=20 Participants
Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SALT will be a computer delivered oral naming + picture naming task.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
Sham: 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
|
|---|---|---|
|
Change in Stroke Impact Scale (SIS) Pre-treatment to Post-treatment
|
2.56 units on a scale
Interval -0.72 to 5.83
|
3.85 units on a scale
Interval 0.5 to 7.2
|
SECONDARY outcome
Timeframe: Immediately before and 5 weeks after treatmentPopulation: Completers sample. Missing data is not imputed. The data was missing for 10 patients.
The SIS was administered at baseline and 5 weeks after treatment to evaluate any lasting changes in quality of life and social engagement. The SIS includes 59 aspects of post-stroke functioning. Participants rate each of the items on a scale from 5 (least encumbered, affected, or difficult) to 1 (most encumbered, affected or difficult). Ratings on each aspect are summed and then transformed to a 100-point scale using the following formula: Score = \[(Actual raw score - lowest possible raw score) / Possible raw score range\] x 100 The last item (#60) assesses the participant's overall perception of recovery and is presented in the form of a visual analog scale from 0 to 100, where 0 = "no recovery" and 100 = "full recovery." Total score is the average of all transformed scores and the overall perception of recovery. Total scores range from 0-100, with higher scores associated with better recovery.
Outcome measures
| Measure |
A-tDCS & SALT
n=23 Participants
A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. The electrical current will be administered to a pre-specified region of the brain. The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes. SALT will be a computer-delivered naming + picture matching task .
A-tDCS (1 mA): 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
|
Sham-tDCS & SALT
n=18 Participants
Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SALT will be a computer delivered oral naming + picture naming task.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
Sham: 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
|
|---|---|---|
|
Change in Stroke Impact Scale (SIS) Pre-treatment to 5 Weeks Post-treatment
|
2.08 units on a scale
Interval -1.17 to 5.33
|
4.18 units on a scale
Interval 0.78 to 7.58
|
SECONDARY outcome
Timeframe: The PNT will be administered at baseline and at 20 weeks post treatment.Population: Completers sample. Missing data is not imputed. The data was missing for 6 patients.
To determine whether A-tDCS coupled with SALT will improve naming performance of participants with post stroke aphasia for a greater duration than SALT alone (i.e., the sham condition). The PNT is a 175-item picture naming test where a person earns one point per each correct answer. Scores range from 0-175 with higher scores associated with better performance.
Outcome measures
| Measure |
A-tDCS & SALT
n=24 Participants
A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. The electrical current will be administered to a pre-specified region of the brain. The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes. SALT will be a computer-delivered naming + picture matching task .
A-tDCS (1 mA): 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
|
Sham-tDCS & SALT
n=21 Participants
Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SALT will be a computer delivered oral naming + picture naming task.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
Sham: 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
|
|---|---|---|
|
Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test) Pre-treatment to 20-weeks Post-treatment
|
34.04 score on a scale
Interval 22.9 to 45.18
|
25.55 score on a scale
Interval 14.13 to 36.97
|
SECONDARY outcome
Timeframe: Immediately before and at 20 weeks after treatmentPopulation: Completers sample. Missing data is not imputed. The data was missing for 10 patients.
The investigators will also record the description of the "Cookie Theft" picture during administration of the National Institutes of Health Stroke Scale before and after treatment, and count the number of Content Units (CU) mentioned by healthy controls. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance.
Outcome measures
| Measure |
A-tDCS & SALT
n=24 Participants
A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. The electrical current will be administered to a pre-specified region of the brain. The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes. SALT will be a computer-delivered naming + picture matching task .
A-tDCS (1 mA): 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
|
Sham-tDCS & SALT
n=17 Participants
Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SALT will be a computer delivered oral naming + picture naming task.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
Sham: 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
|
|---|---|---|
|
Change in Content of Picture Description Pre-treatment to 20-weeks Post-treatment
|
5.15 units on a scale
Interval 2.94 to 7.35
|
3.28 units on a scale
Interval 0.72 to 5.85
|
SECONDARY outcome
Timeframe: Immediately before and at 20 weeks after treatmentPopulation: Completers sample. Missing data is not imputed. The data was missing for 10 patients.
The investigators determined the number of syllables/content unit (CU) in the Cookie Theft description, then calculated the difference between this performance pre-treatment and 20-weeks post-treatment. Syllables/CU provides a sensitive measure of efficiency of narrative speech in all levels of aphasia. Greater efficiency (fewer syllables required to convey a given amount of content) is associated with improvement in language. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance. A person who does not produce any language would have zero syllables, but there is no maximum number of syllables a person is allowed to produce in response to the task.
Outcome measures
| Measure |
A-tDCS & SALT
n=24 Participants
A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. The electrical current will be administered to a pre-specified region of the brain. The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes. SALT will be a computer-delivered naming + picture matching task .
A-tDCS (1 mA): 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
|
Sham-tDCS & SALT
n=17 Participants
Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SALT will be a computer delivered oral naming + picture naming task.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
Sham: 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
|
|---|---|---|
|
Change in the Efficiency of Picture Description Pre-treatment to 20 Weeks Post-treatment
|
-14.75 units on a scale
Interval -22.58 to -6.91
|
6.53 units on a scale
Interval -3.63 to 16.69
|
SECONDARY outcome
Timeframe: Immediately before and 20 weeks after treatmentPopulation: Completers sample. Missing data is not imputed. The data was missing for 10 patients.
The SIS was administered at baseline and 20 weeks after treatment to evaluate any lasting changes in quality of life and social engagement. The SIS includes 59 aspects of post-stroke functioning. Participants rate each of the items on a scale from 5 (least encumbered, affected, or difficult) to 1 (most encumbered, affected or difficult). Ratings on each aspect are summed and then transformed to a 100-point scale using the following formula: Score = \[(Actual raw score - lowest possible raw score) / Possible raw score range\] x 100 The last item (#60) assesses the participant's overall perception of recovery and is presented in the form of a visual analog scale from 0 to 100, where 0 = "no recovery" and 100 = "full recovery." Total score is the average of all transformed scores and the overall perception of recovery. Total scores range from 0-100, with higher scores associated with better recovery.
Outcome measures
| Measure |
A-tDCS & SALT
n=23 Participants
A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. The electrical current will be administered to a pre-specified region of the brain. The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes. SALT will be a computer-delivered naming + picture matching task .
A-tDCS (1 mA): 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
|
Sham-tDCS & SALT
n=18 Participants
Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SALT will be a computer delivered oral naming + picture naming task.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
Sham: 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
|
|---|---|---|
|
Change in Stroke Impact Scale (SIS) Pre-treatment to 20 Weeks Post-treatment
|
2.60 score on a scale
Interval -0.65 to 5.86
|
4.28 score on a scale
Interval 0.88 to 7.69
|
Adverse Events
A-tDCS & SALT
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Sham-tDCS & SALT
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A-tDCS & SALT
n=26 participants at risk
A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. The electrical current will be administered to a pre-specified region of the brain. The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes. SALT will be a computer-delivered naming + picture matching task .
A-tDCS (1 mA): 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
|
Sham-tDCS & SALT
n=25 participants at risk
Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SALT will be a computer delivered oral naming + picture naming task.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
Sham: 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
|
|---|---|---|
|
Nervous system disorders
Cerebrovascular accident
|
3.8%
1/26 • Number of events 1 • 20 weeks
|
4.0%
1/25 • Number of events 1 • 20 weeks
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/26 • 20 weeks
|
4.0%
1/25 • Number of events 1 • 20 weeks
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
3.8%
1/26 • Number of events 1 • 20 weeks
|
0.00%
0/25 • 20 weeks
|
Other adverse events
| Measure |
A-tDCS & SALT
n=26 participants at risk
A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. The electrical current will be administered to a pre-specified region of the brain. The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes. SALT will be a computer-delivered naming + picture matching task .
A-tDCS (1 mA): 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
|
Sham-tDCS & SALT
n=25 participants at risk
Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SALT will be a computer delivered oral naming + picture naming task.
SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
Sham: 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
|
|---|---|---|
|
General disorders
Application site irritation
|
11.5%
3/26 • Number of events 3 • 20 weeks
|
0.00%
0/25 • 20 weeks
|
|
Eye disorders
Diplopia
|
3.8%
1/26 • Number of events 1 • 20 weeks
|
0.00%
0/25 • 20 weeks
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/26 • 20 weeks
|
4.0%
1/25 • Number of events 1 • 20 weeks
|
|
Nervous system disorders
Headache
|
3.8%
1/26 • Number of events 1 • 20 weeks
|
0.00%
0/25 • 20 weeks
|
Additional Information
Dr. Argye Hillis, MD
Johns Hopkins University School of Medicine
Phone: 4109552228
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place