Trial Outcomes & Findings for Effects of Transcranial Direct Current Stimulation (tDCS) on Language (NCT NCT04166513)
NCT ID: NCT04166513
Last Updated: 2025-10-03
Results Overview
Improvement on trained, untrained and untested items used during therapy. Items will consist of words and pictures that participants will name. Percent correct on lists after each therapy cycle will be the primary behavioral outcome measure (items chosen were at baseline is 0% correct). There were 20 pictures and 20 words in each of the trained, untrained, and untested lists. Pictures were colored photographs. Cycle A is the speech therapy intervention given first, Cycle B is the speech therapy intervention given second Cycle A Trained and Untrained lists were assessed on the last day of therapy for Cycle A Cycle A Post Trained, Untrained and Untested lists were given during Behavioral Assessment 2, approximately 10-weeks post ending Cycle A. Cycle B Trained and Untrained lists were assessed on the last day of therapy for Cycle B Cycle B Post Trained, Untrained and Untested lists were given during Behavioral Assessment 3, approximately 10-weeks post ending Cycle A.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post
Results posted on
2025-10-03
Participant Flow
Recruitment took place from August 5, 2019 through April 30, 2024 at a medical clinic and from an aphasia databank. The first participant was enrolled on December 13, 2019, and the last participant was enrolled August 11, 2023.
After enrollment, participants underwent screening tests to ensure behavioral criteria was met. Of the 25 enrollments, 19 met behavioral criteria and were randomized into an arm. Those who did not meet behavioral criteria did not continue in the study.
Participant milestones
| Measure |
Phonologic-Focused Speech Therapy - Targeted tDCS First (A), Then Active Control tDCS (B)
Participants will receive phonologic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions before crossing over to receive Active Control tDCS for 10 sessions.
Transcranial Direct Current Stimulation: High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes. Stimulation is either applied to the targeted or active control region, depending on the therapy cycle.
Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture.
|
Phonologic-Focused Speech Therapy - Active Control tDCS First (A), Then Targeted tDCS (B)
Participants will receive phonologic-focused speech therapy with active control tDCS for 10 therapy sessions before crossing over to receive target control tDCS for 10 therapy sessions.
Transcranial Direct Current Stimulation: High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes. Stimulation is either applied to the targeted or active control region, depending on the therapy cycle.
Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture.
|
Semantic-Focused Speech Therapy - Targeted tDCS First (A), Then Active Control tDCS (B)
Participants will receive semantic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions before crossing over to receive active-control tDCS for 10 therapy sessions.
Transcranial Direct Current Stimulation: High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes. Stimulation is either applied to the targeted or active control region, depending on the therapy cycle.
Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word.
|
Semantic-Focused Speech Therapy Active Control tDCS First (A), Then Targeted tDCS (B)
Participants will receive semantic-focused speech therapy with active control tDCS for 10 therapy sessions before crossing over to receive targted tDCS for 10 therapy sessions.
Transcranial Direct Current Stimulation: High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes. Stimulation is either applied to the targeted or active control region, depending on the therapy cycle.
Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word.
|
|---|---|---|---|---|
|
Behavioral Assessment 1
STARTED
|
5
|
5
|
4
|
5
|
|
Behavioral Assessment 1
COMPLETED
|
5
|
4
|
4
|
4
|
|
Behavioral Assessment 1
NOT COMPLETED
|
0
|
1
|
0
|
1
|
|
FMRI Session 1
STARTED
|
5
|
4
|
4
|
4
|
|
FMRI Session 1
COMPLETED
|
5
|
4
|
4
|
4
|
|
FMRI Session 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Therapy Cycle A
STARTED
|
5
|
4
|
4
|
4
|
|
Therapy Cycle A
COMPLETED
|
5
|
4
|
4
|
4
|
|
Therapy Cycle A
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Behavioral Assessment 2
STARTED
|
5
|
4
|
4
|
4
|
|
Behavioral Assessment 2
COMPLETED
|
5
|
4
|
4
|
4
|
|
Behavioral Assessment 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
FMRI Session 2
STARTED
|
5
|
4
|
4
|
4
|
|
FMRI Session 2
COMPLETED
|
5
|
4
|
4
|
4
|
|
FMRI Session 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Therapy Cycle B
STARTED
|
4
|
4
|
3
|
4
|
|
Therapy Cycle B
COMPLETED
|
4
|
3
|
3
|
4
|
|
Therapy Cycle B
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Behavioral Assessment 3
STARTED
|
4
|
3
|
3
|
4
|
|
Behavioral Assessment 3
COMPLETED
|
4
|
3
|
3
|
4
|
|
Behavioral Assessment 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
FMRI Session 3
STARTED
|
4
|
3
|
3
|
4
|
|
FMRI Session 3
COMPLETED
|
4
|
3
|
3
|
4
|
|
FMRI Session 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Behavioral Assessment 4
STARTED
|
3
|
3
|
3
|
3
|
|
Behavioral Assessment 4
COMPLETED
|
0
|
1
|
1
|
2
|
|
Behavioral Assessment 4
NOT COMPLETED
|
3
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
Phonologic-Focused Speech Therapy - Targeted tDCS First (A), Then Active Control tDCS (B)
Participants will receive phonologic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions before crossing over to receive Active Control tDCS for 10 sessions.
Transcranial Direct Current Stimulation: High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes. Stimulation is either applied to the targeted or active control region, depending on the therapy cycle.
Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture.
|
Phonologic-Focused Speech Therapy - Active Control tDCS First (A), Then Targeted tDCS (B)
Participants will receive phonologic-focused speech therapy with active control tDCS for 10 therapy sessions before crossing over to receive target control tDCS for 10 therapy sessions.
Transcranial Direct Current Stimulation: High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes. Stimulation is either applied to the targeted or active control region, depending on the therapy cycle.
Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture.
|
Semantic-Focused Speech Therapy - Targeted tDCS First (A), Then Active Control tDCS (B)
Participants will receive semantic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions before crossing over to receive active-control tDCS for 10 therapy sessions.
Transcranial Direct Current Stimulation: High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes. Stimulation is either applied to the targeted or active control region, depending on the therapy cycle.
Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word.
|
Semantic-Focused Speech Therapy Active Control tDCS First (A), Then Targeted tDCS (B)
Participants will receive semantic-focused speech therapy with active control tDCS for 10 therapy sessions before crossing over to receive targted tDCS for 10 therapy sessions.
Transcranial Direct Current Stimulation: High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes. Stimulation is either applied to the targeted or active control region, depending on the therapy cycle.
Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word.
|
|---|---|---|---|---|
|
Behavioral Assessment 1
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Behavioral Assessment 1
Investigator Withdrawn
|
0
|
0
|
0
|
1
|
|
Therapy Cycle B
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Behavioral Assessment 4
Lost to Follow-up
|
1
|
0
|
1
|
1
|
|
Behavioral Assessment 4
Withdrawal by Subject
|
2
|
2
|
1
|
0
|
Baseline Characteristics
Effects of Transcranial Direct Current Stimulation (tDCS) on Language
Baseline characteristics by cohort
| Measure |
Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS
n=5 Participants
Phonologic-Focused Speech Therapy - Targeted tDCS first, then Active Control tDCS.
Participants receive phonologic speech therapy for both cycles of speech therapy. They receive targeted tDCS first, then active control tDCS second.
Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture.
|
Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS
n=5 Participants
Phonologic-Focused Speech Therapy - Active Control tDCS first, then Targeted tDCS
Participants receive phonologic speech therapy for both cycles of speech therapy. They receive active control tDCS first, then targeted tDCS second.
Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture.
|
Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS
n=4 Participants
Semantic-Focused Speech Therapy - Targeted tDCS first, then Active Control tDCS
Participants receive semantic speech therapy for both cycles of speech therapy. They receive targeted tDCS first, then active control tDCS second.
Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word.
|
Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS
n=5 Participants
Semantic-Focused Speech Therapy - Targeted tDCS first, then Active Control tDCS
Participants receive semantic speech therapy for both cycles of speech therapy. They receive active control tDCS first, then targeted tDCS second.
Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Age, Continuous
|
47.8 years
n=5 Participants
|
50.8 years
n=7 Participants
|
47.75 years
n=5 Participants
|
59.8 years
n=4 Participants
|
51.54 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
19 participants
n=21 Participants
|
|
Days Past Stroke Onset
|
1525 days
n=5 Participants
|
1697 days
n=7 Participants
|
1260 days
n=5 Participants
|
1262 days
n=4 Participants
|
1436 days
n=21 Participants
|
|
Years of Education
|
15.2 years
n=5 Participants
|
17 years
n=7 Participants
|
14.5 years
n=5 Participants
|
13.2 years
n=4 Participants
|
14.9 years
n=21 Participants
|
PRIMARY outcome
Timeframe: Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks postPopulation: Cycle B participant analyzed is less than overall number to reflect participants who dropped out of the study part-way through
Improvement on trained, untrained and untested items used during therapy. Items will consist of words and pictures that participants will name. Percent correct on lists after each therapy cycle will be the primary behavioral outcome measure (items chosen were at baseline is 0% correct). There were 20 pictures and 20 words in each of the trained, untrained, and untested lists. Pictures were colored photographs. Cycle A is the speech therapy intervention given first, Cycle B is the speech therapy intervention given second Cycle A Trained and Untrained lists were assessed on the last day of therapy for Cycle A Cycle A Post Trained, Untrained and Untested lists were given during Behavioral Assessment 2, approximately 10-weeks post ending Cycle A. Cycle B Trained and Untrained lists were assessed on the last day of therapy for Cycle B Cycle B Post Trained, Untrained and Untested lists were given during Behavioral Assessment 3, approximately 10-weeks post ending Cycle A.
Outcome measures
| Measure |
Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS
n=5 Participants
Phonologic-Focused Speech Therapy - Targeted tDCS first, then Active Control tDCS
Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture. There are 10 therapy sessions in each cycle.
|
Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS
n=5 Participants
Phonologic-Focused Speech Therapy - Active Control tDCS first, then Targeted tDCS
Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture. There are 10 therapy sessions in each cycle.
|
Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS
n=4 Participants
Semantic-Focused Speech Therapy - Targeted tDCS first, then Active Control tDCS
Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. There are 10 therapy sessions in each cycle.
|
Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS
n=5 Participants
Semantic-Focused Speech Therapy Active Control tDCS first, then Targeted tDCS
Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. There are 10 speech therapy sessions in each cycle.
|
|---|---|---|---|---|
|
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
CycleATrainPics
|
49 percentage of items correct
Standard Deviation 47
|
72 percentage of items correct
Standard Deviation 3
|
56 percentage of items correct
Standard Deviation 43
|
56 percentage of items correct
Standard Deviation 30
|
|
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
CycleATrainWord
|
47 percentage of items correct
Standard Deviation 43
|
65 percentage of items correct
Standard Deviation 5
|
50 percentage of items correct
Standard Deviation 13
|
42 percentage of items correct
Standard Deviation 39
|
|
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
CycleAUntrainPic
|
17 percentage of items correct
Standard Deviation 24
|
30 percentage of items correct
Standard Deviation 15
|
25 percentage of items correct
Standard Deviation 24
|
10 percentage of items correct
Standard Deviation 11
|
|
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
CycleAUntrainWord
|
18 percentage of items correct
Standard Deviation 21
|
35 percentage of items correct
Standard Deviation 13
|
27 percentage of items correct
Standard Deviation 15
|
27 percentage of items correct
Standard Deviation 29
|
|
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
PostCycleATrainPic
|
39 percentage of items correct
Standard Deviation 34
|
48 percentage of items correct
Standard Deviation 19
|
44 percentage of items correct
Standard Deviation 32
|
30 percentage of items correct
Standard Deviation 18
|
|
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
PostCycleATrainWord
|
36 percentage of items correct
Standard Deviation 29
|
45 percentage of items correct
Standard Deviation 5
|
33 percentage of items correct
Standard Deviation 13
|
45 percentage of items correct
Standard Deviation 35
|
|
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
PostCycleAUntestPics
|
18 percentage of items correct
Standard Deviation 15
|
33 percentage of items correct
Standard Deviation 25
|
38 percentage of items correct
Standard Deviation 29
|
13 percentage of items correct
Standard Deviation 18
|
|
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
PostCycleAUntestWord
|
22 percentage of items correct
Standard Deviation 19
|
27 percentage of items correct
Standard Deviation 20
|
36 percentage of items correct
Standard Deviation 25
|
55 percentage of items correct
Standard Deviation 21
|
|
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
PostCycleAUntrainPic
|
21 percentage of items correct
Standard Deviation 18
|
23 percentage of items correct
Standard Deviation 20
|
35 percentage of items correct
Standard Deviation 13
|
18 percentage of items correct
Standard Deviation 6
|
|
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
PostCycleAUntrainWord
|
21 percentage of items correct
Standard Deviation 15
|
33 percentage of items correct
Standard Deviation 18
|
30 percentage of items correct
Standard Deviation 14
|
32 percentage of items correct
Standard Deviation 29
|
|
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
CycleBTrainPic
|
65 percentage of items correct
Standard Deviation 46
|
64 percentage of items correct
Standard Deviation 22
|
42 percentage of items correct
Standard Deviation 35
|
57 percentage of items correct
Standard Deviation 36
|
|
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
CycleBTrainWord
|
66 percentage of items correct
Standard Deviation 31
|
65 percentage of items correct
Standard Deviation 26
|
47 percentage of items correct
Standard Deviation 33
|
57 percentage of items correct
Standard Deviation 29
|
|
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
CycleBUntrainPic
|
24 percentage of items correct
Standard Deviation 21
|
19 percentage of items correct
Standard Deviation 21
|
28 percentage of items correct
Standard Deviation 32
|
19 percentage of items correct
Standard Deviation 16
|
|
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
CycleBUntrainWord
|
24 percentage of items correct
Standard Deviation 19
|
24 percentage of items correct
Standard Deviation 19
|
32 percentage of items correct
Standard Deviation 10
|
38 percentage of items correct
Standard Deviation 45
|
|
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
PostCycleBTrainPic
|
43 percentage of items correct
Standard Deviation 37
|
21 percentage of items correct
Standard Deviation 17
|
30 percentage of items correct
Standard Deviation 26
|
33 percentage of items correct
Standard Deviation 20
|
|
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
PostCycleBTrainWord
|
51 percentage of items correct
Standard Deviation 34
|
40 percentage of items correct
Standard Deviation 24
|
27 percentage of items correct
Standard Deviation 14
|
37 percentage of items correct
Standard Deviation 28
|
|
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
PostCycleBUntestPic
|
21 percentage of items correct
Standard Deviation 20
|
19 percentage of items correct
Standard Deviation 6
|
20 percentage of items correct
Standard Deviation 26
|
30 percentage of items correct
Standard Deviation 13
|
|
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
PostCycleBUntestWord
|
19 percentage of items correct
Standard Deviation 19
|
16 percentage of items correct
Standard Deviation 11
|
28 percentage of items correct
Standard Deviation 20
|
32 percentage of items correct
Standard Deviation 43
|
|
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
PostCycleBUntrainPic
|
27 percentage of items correct
Standard Deviation 17
|
24 percentage of items correct
Standard Deviation 15
|
28 percentage of items correct
Standard Deviation 24
|
29 percentage of items correct
Standard Deviation 20
|
|
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
PostCycleBUntrainWord
|
23 percentage of items correct
Standard Deviation 18
|
28 percentage of items correct
Standard Deviation 18
|
35 percentage of items correct
Standard Deviation 13
|
38 percentage of items correct
Standard Deviation 42
|
SECONDARY outcome
Timeframe: BaselineNumber of participants completing Rs-fMRI before therapy.
Outcome measures
| Measure |
Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS
n=5 Participants
Phonologic-Focused Speech Therapy - Targeted tDCS first, then Active Control tDCS
Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture. There are 10 therapy sessions in each cycle.
|
Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS
n=5 Participants
Phonologic-Focused Speech Therapy - Active Control tDCS first, then Targeted tDCS
Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture. There are 10 therapy sessions in each cycle.
|
Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS
n=4 Participants
Semantic-Focused Speech Therapy - Targeted tDCS first, then Active Control tDCS
Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. There are 10 therapy sessions in each cycle.
|
Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS
n=5 Participants
Semantic-Focused Speech Therapy Active Control tDCS first, then Targeted tDCS
Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. There are 10 speech therapy sessions in each cycle.
|
|---|---|---|---|---|
|
fMRI- Baseline
|
5 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 10-weeks post Cycle ANumber of participants completing Rs-fMRI after Cycle A therapy.
Outcome measures
| Measure |
Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS
n=5 Participants
Phonologic-Focused Speech Therapy - Targeted tDCS first, then Active Control tDCS
Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture. There are 10 therapy sessions in each cycle.
|
Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS
n=4 Participants
Phonologic-Focused Speech Therapy - Active Control tDCS first, then Targeted tDCS
Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture. There are 10 therapy sessions in each cycle.
|
Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS
n=4 Participants
Semantic-Focused Speech Therapy - Targeted tDCS first, then Active Control tDCS
Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. There are 10 therapy sessions in each cycle.
|
Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS
n=4 Participants
Semantic-Focused Speech Therapy Active Control tDCS first, then Targeted tDCS
Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. There are 10 speech therapy sessions in each cycle.
|
|---|---|---|---|---|
|
fMRI After Cycle A
|
5 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 10 weeks post cycle BNumber of participants completing fMRI post Cycle B
Outcome measures
| Measure |
Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS
n=4 Participants
Phonologic-Focused Speech Therapy - Targeted tDCS first, then Active Control tDCS
Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture. There are 10 therapy sessions in each cycle.
|
Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS
n=3 Participants
Phonologic-Focused Speech Therapy - Active Control tDCS first, then Targeted tDCS
Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture. There are 10 therapy sessions in each cycle.
|
Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS
n=3 Participants
Semantic-Focused Speech Therapy - Targeted tDCS first, then Active Control tDCS
Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. There are 10 therapy sessions in each cycle.
|
Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS
n=4 Participants
Semantic-Focused Speech Therapy Active Control tDCS first, then Targeted tDCS
Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. There are 10 speech therapy sessions in each cycle.
|
|---|---|---|---|---|
|
fMRI Post Cycle B
|
4 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 time points: pre-assessment, 10 weeks post-therapy cycle A and 10 weeks post-therapy cycle BPopulation: Number below analyzed is different from overall number analyzed due to participants dropping out of study or self-report forms incomplete.
A language battery screen assessing different language processes and providing an overall severity score (Quick Aphasia Battery or QAB) will be repeated three times (Time 1, Time 2, Time 3). Also outcomes on self-reported measures assessing confidence with speaking: Communicative Effectiveness Index (CETI), Communication Confidence Rating Scale for Aphasia (CCRSA) and overall symptoms of depression; Center for Epidemiologic Studies Short Depression Scale (CES-D-10). QAB = Total score range 0-10, higher scores mean less severe aphasia severity CETI= Total score range 1-100, higher scores mean better perceived communication confidence by an outside rater CCRSA = Total score range 0-100, higher scores mean more confidence in speaking ability CES-D-10= Total score range 0-30, scores \>10 indicate symptoms of depression
Outcome measures
| Measure |
Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS
n=5 Participants
Phonologic-Focused Speech Therapy - Targeted tDCS first, then Active Control tDCS
Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture. There are 10 therapy sessions in each cycle.
|
Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS
n=4 Participants
Phonologic-Focused Speech Therapy - Active Control tDCS first, then Targeted tDCS
Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture. There are 10 therapy sessions in each cycle.
|
Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS
n=4 Participants
Semantic-Focused Speech Therapy - Targeted tDCS first, then Active Control tDCS
Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. There are 10 therapy sessions in each cycle.
|
Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS
n=4 Participants
Semantic-Focused Speech Therapy Active Control tDCS first, then Targeted tDCS
Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. There are 10 speech therapy sessions in each cycle.
|
|---|---|---|---|---|
|
Performance on Outcome Measures Assessed Through the Language Battery
QAB total T1
|
6 score on a scale
Standard Deviation 3
|
6 score on a scale
Standard Deviation 1
|
7 score on a scale
Standard Deviation 2
|
7 score on a scale
Standard Deviation 2
|
|
Performance on Outcome Measures Assessed Through the Language Battery
QAB total T3
|
6 score on a scale
Standard Deviation 3
|
7 score on a scale
Standard Deviation 1
|
6 score on a scale
Standard Deviation 0
|
7 score on a scale
Standard Deviation 3
|
|
Performance on Outcome Measures Assessed Through the Language Battery
CETI T1
|
66 score on a scale
Standard Deviation 38
|
100 score on a scale
Standard Deviation 32
|
78 score on a scale
Standard Deviation 28
|
102 score on a scale
Standard Deviation 37
|
|
Performance on Outcome Measures Assessed Through the Language Battery
CETI T2
|
82 score on a scale
Standard Deviation 61
|
122 score on a scale
Standard Deviation 13
|
81 score on a scale
Standard Deviation 27
|
104 score on a scale
Standard Deviation 30
|
|
Performance on Outcome Measures Assessed Through the Language Battery
CCRSA T2
|
51 score on a scale
Standard Deviation 24
|
77 score on a scale
Standard Deviation 17
|
66 score on a scale
Standard Deviation 22
|
63 score on a scale
Standard Deviation 15
|
|
Performance on Outcome Measures Assessed Through the Language Battery
CESD T1
|
13 score on a scale
Standard Deviation 8
|
7 score on a scale
Standard Deviation 8
|
13 score on a scale
Standard Deviation 13
|
4 score on a scale
Standard Deviation 5
|
|
Performance on Outcome Measures Assessed Through the Language Battery
QAB total T2
|
5 score on a scale
Standard Deviation 4
|
7 score on a scale
Standard Deviation 1
|
7 score on a scale
Standard Deviation 2
|
7 score on a scale
Standard Deviation 2
|
|
Performance on Outcome Measures Assessed Through the Language Battery
CETI T3
|
85 score on a scale
Standard Deviation 60
|
117 score on a scale
Standard Deviation 15
|
83 score on a scale
Standard Deviation 17
|
108 score on a scale
Standard Deviation 21
|
|
Performance on Outcome Measures Assessed Through the Language Battery
CCRSA T1
|
50 score on a scale
Standard Deviation 20
|
68 score on a scale
Standard Deviation 29
|
56 score on a scale
Standard Deviation 23
|
66 score on a scale
Standard Deviation 26
|
|
Performance on Outcome Measures Assessed Through the Language Battery
CCRSA T3
|
61 score on a scale
Standard Deviation 20
|
78 score on a scale
Standard Deviation 9
|
71 score on a scale
Standard Deviation 10
|
71 score on a scale
Standard Deviation 11
|
|
Performance on Outcome Measures Assessed Through the Language Battery
CESD T2
|
8 score on a scale
Standard Deviation 4
|
5 score on a scale
Standard Deviation 6
|
8 score on a scale
Standard Deviation 6
|
8 score on a scale
Standard Deviation 7
|
|
Performance on Outcome Measures Assessed Through the Language Battery
CESD T3
|
8 score on a scale
Standard Deviation 4
|
8 score on a scale
Standard Deviation 7
|
6 score on a scale
Standard Deviation 4
|
5 score on a scale
Standard Deviation 9
|
Adverse Events
Phonologic-Focused Speech Therapy - Targeted tDCS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phonologic-Focused Speech Therapy - Active Control tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Semantic-Focused Speech Therapy - Targeted tDCS
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Semantic-Focused Speech Therapy - Active Control tDCS
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phonologic-Focused Speech Therapy - Targeted tDCS
n=8 participants at risk
Phonologic-Focused Speech Therapy - Targeted tDCS
Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture.
|
Phonologic-Focused Speech Therapy - Active Control tDCS
n=8 participants at risk
Phonologic-Focused Speech Therapy - Active Control tDCS
Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture.
|
Semantic-Focused Speech Therapy - Targeted tDCS
n=8 participants at risk
Semantic-Focused Speech Therapy - Targeted tDCS
Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word.
|
Semantic-Focused Speech Therapy - Active Control tDCS
n=7 participants at risk
Semantic-Focused Speech Therapy Active Control tDCS
Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word.
|
|---|---|---|---|---|
|
General disorders
Headache
|
0.00%
0/8 • Adverse event data were collected from the first day of intervention until up to six months after the last day of intervention.
Adverse event data were collected systematically on the last day of each treatment period. Non-systematic adverse event data were also collected during a participant's study duration starting from the first study activity until up to 6 months post treatment 2.
|
0.00%
0/8 • Adverse event data were collected from the first day of intervention until up to six months after the last day of intervention.
Adverse event data were collected systematically on the last day of each treatment period. Non-systematic adverse event data were also collected during a participant's study duration starting from the first study activity until up to 6 months post treatment 2.
|
12.5%
1/8 • Adverse event data were collected from the first day of intervention until up to six months after the last day of intervention.
Adverse event data were collected systematically on the last day of each treatment period. Non-systematic adverse event data were also collected during a participant's study duration starting from the first study activity until up to 6 months post treatment 2.
|
0.00%
0/7 • Adverse event data were collected from the first day of intervention until up to six months after the last day of intervention.
Adverse event data were collected systematically on the last day of each treatment period. Non-systematic adverse event data were also collected during a participant's study duration starting from the first study activity until up to 6 months post treatment 2.
|
|
Skin and subcutaneous tissue disorders
Skin Discomfort
|
12.5%
1/8 • Adverse event data were collected from the first day of intervention until up to six months after the last day of intervention.
Adverse event data were collected systematically on the last day of each treatment period. Non-systematic adverse event data were also collected during a participant's study duration starting from the first study activity until up to 6 months post treatment 2.
|
0.00%
0/8 • Adverse event data were collected from the first day of intervention until up to six months after the last day of intervention.
Adverse event data were collected systematically on the last day of each treatment period. Non-systematic adverse event data were also collected during a participant's study duration starting from the first study activity until up to 6 months post treatment 2.
|
25.0%
2/8 • Adverse event data were collected from the first day of intervention until up to six months after the last day of intervention.
Adverse event data were collected systematically on the last day of each treatment period. Non-systematic adverse event data were also collected during a participant's study duration starting from the first study activity until up to 6 months post treatment 2.
|
28.6%
2/7 • Adverse event data were collected from the first day of intervention until up to six months after the last day of intervention.
Adverse event data were collected systematically on the last day of each treatment period. Non-systematic adverse event data were also collected during a participant's study duration starting from the first study activity until up to 6 months post treatment 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place