Trial Outcomes & Findings for Post-Stroke Aphasia and Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment Study (NCT NCT01512264)
NCT ID: NCT01512264
Last Updated: 2020-07-14
Results Overview
60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.
COMPLETED
NA
28 participants
Baseline: 1 week before the first nerTMS treatment
2020-07-14
Participant Flow
Participant milestones
| Measure |
rTMS
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
rTMS
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Post-Stroke Aphasia and Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment Study
Baseline characteristics by cohort
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=7 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
22 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
20 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
18 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=93 Participants
|
7 participants
n=4 Participants
|
6 participants
n=27 Participants
|
7 participants
n=483 Participants
|
27 participants
n=36 Participants
|
|
Region of Enrollment
India
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
1 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline: 1 week before the first nerTMS treatmentPopulation: 1 participant from control group was unable to be analyzed due to loss of follow up.
60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.
Outcome measures
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=6 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Baseline
|
33.43 units on a scale
Standard Deviation 17.67
|
18.29 units on a scale
Standard Deviation 18.94
|
28.57 units on a scale
Standard Deviation 24.21
|
41.00 units on a scale
Standard Deviation 13.56
|
PRIMARY outcome
Timeframe: within 1 week post treatmentPopulation: 1 participant from control group was unable to be analyzed due to loss of follow up.
60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.
Outcome measures
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=6 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Immediate Follow-Up
|
42.43 units on a scale
Standard Deviation 18.32
|
24.86 units on a scale
Standard Deviation 22.23
|
30.86 units on a scale
Standard Deviation 24.65
|
48.83 units on a scale
Standard Deviation 10.26
|
PRIMARY outcome
Timeframe: 3 months post treatmentPopulation: 1 participant from control group was unable to be analyzed due to loss of follow up.
60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.
Outcome measures
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=6 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Long Term Follow-up
|
38.50 units on a scale
Standard Deviation 20.44
|
15.67 units on a scale
Standard Deviation 17.69
|
25.17 units on a scale
Standard Deviation 24.69
|
47.60 units on a scale
Standard Deviation 9.56
|
PRIMARY outcome
Timeframe: 1 week before the first nerTMS treatmentPopulation: 1 participant from control group was unable to be analyzed due to loss of follow up.
The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. "Animals", "Fruits") and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.
Outcome measures
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=6 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Baseline
|
16.29 words generated
Standard Deviation 13.01
|
8.00 words generated
Standard Deviation 7.66
|
9.57 words generated
Standard Deviation 9.03
|
25.50 words generated
Standard Deviation 8.92
|
PRIMARY outcome
Timeframe: within 1 week post treatmentPopulation: 1 participant from control group was unable to be analyzed due to loss of follow up.
The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. "Animals", "Fruits") and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.
Outcome measures
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=6 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Immediate Follow-up
|
18.86 units on a scale
Standard Deviation 13.43
|
8.86 units on a scale
Standard Deviation 8.76
|
11.14 units on a scale
Standard Deviation 10.11
|
29.17 units on a scale
Standard Deviation 9.58
|
PRIMARY outcome
Timeframe: 3 months post treatmentPopulation: 1 participant from control group was unable to be analyzed due to loss of follow up.
The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. "Animals", "Fruits") and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.
Outcome measures
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=6 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Long Term Follow-up
|
19.00 words generated
Standard Deviation 12.86
|
7.50 words generated
Standard Deviation 8.87
|
9.83 words generated
Standard Deviation 9.39
|
30.40 words generated
Standard Deviation 5.32
|
PRIMARY outcome
Timeframe: 1 week before the first nerTMS treatmentPopulation: 1 participant from control group was unable to be analyzed due to loss of follow up.
The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. "C", "F", "L") and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.
Outcome measures
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=6 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Baseline
|
9.29 words generated
Standard Deviation 8.14
|
4.43 words generated
Standard Deviation 6.24
|
4.86 words generated
Standard Deviation 3.98
|
9.33 words generated
Standard Deviation 5.68
|
PRIMARY outcome
Timeframe: within 1 week post treatmentPopulation: 1 participant from control group was unable to be analyzed due to loss of follow up.
The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. "C", "F", "L") and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.
Outcome measures
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=6 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Immediate Follow-up
|
12.43 words generated
Standard Deviation 10.13
|
5.43 words generated
Standard Deviation 5.53
|
5.00 words generated
Standard Deviation 5.35
|
10.17 words generated
Standard Deviation 5.56
|
PRIMARY outcome
Timeframe: 3 months post treatmentPopulation: 1 participant from control group was unable to be analyzed due to loss of follow up.
The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. "C", "F", "L") and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.
Outcome measures
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=6 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Long Term Follow-up
|
9.67 words generated
Standard Deviation 8.38
|
3.33 words generated
Standard Deviation 4.18
|
4.67 words generated
Standard Deviation 5.47
|
12.60 words generated
Standard Deviation 5.50
|
PRIMARY outcome
Timeframe: Baseline: 1 week before the first nerTMS treatmentPopulation: 1 participant from control group was unable to be analyzed due to loss of follow up.
WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild.
Outcome measures
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=6 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Western Aphasia Battery (WAB) - Baseline
|
64.214 units on a scale
Standard Deviation 33.201
|
54.883 units on a scale
Standard Deviation 28.649
|
54.380 units on a scale
Standard Deviation 27.405
|
81.740 units on a scale
Standard Deviation 13.639
|
PRIMARY outcome
Timeframe: within 1 week post treatmentPopulation: 1 participant from control group was unable to be analyzed due to loss of follow up.
WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild.
Outcome measures
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=6 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Western Aphasia Battery (WAB) - Immediate Follow-Up
|
63.500 units on a scale
Standard Deviation 36.559
|
51.520 units on a scale
Standard Deviation 27.751
|
57.460 units on a scale
Standard Deviation 28.076
|
77.700 units on a scale
Standard Deviation 12.895
|
PRIMARY outcome
Timeframe: 3 months post treatmentPopulation: 1 participant from control group was unable to be analyzed due to loss of follow up.
WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild.
Outcome measures
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=6 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Western Aphasia Battery (WAB) - Long-Term Follow-Up
|
72.417 units on a scale
Standard Deviation 31.692
|
50.560 units on a scale
Standard Deviation 27.219
|
61.960 units on a scale
Standard Deviation 31.587
|
84.425 units on a scale
Standard Deviation 12.807
|
SECONDARY outcome
Timeframe: Baseline: 1 week before the first nerTMS treatmentPopulation: 1 participant from control group was unable to be analyzed due to loss of follow up.
Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from "-1" (or -100%) indicating left-hemispheric lateralization to "1" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).
Outcome measures
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=6 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Change in Language Laterilazation as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Baseline
|
0.30 Index score
Standard Deviation 0.40
|
0.22 Index score
Standard Deviation 0.20
|
-0.19 Index score
Standard Deviation 0.30
|
0.13 Index score
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: within 1 week post treatmentPopulation: 1 participant from control group was unable to be analyzed due to loss of follow up.
Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from "-1" (or -100%) indicating left-hemispheric lateralization to "1" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).
Outcome measures
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=6 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Immediate Follow-up
|
0.02 index score
Standard Deviation 0.40
|
0.09 index score
Standard Deviation 0.46
|
-0.09 index score
Standard Deviation 0.55
|
-0.01 index score
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: 3 months post treatmentPopulation: 1 participant from control group was unable to be analyzed due to loss of follow up.
Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from "-1" (or -100%) indicating left-hemispheric lateralization to "1" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).
Outcome measures
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=6 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Long-term Follow Up
|
0.20 index score
Standard Deviation 0.41
|
0.20 index score
Standard Deviation 0.36
|
0.01 index score
Standard Deviation 0.69
|
0.20 index score
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: Baseline: 1 week before the first nerTMS treatmentPopulation: 1 participant from control group was unable to be analyzed due to loss of follow up.
Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from "-1" (or -100%) indicating left-hemispheric lateralization to "1" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).
Outcome measures
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=6 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Baseline
|
0.14 index score
Standard Deviation 0.21
|
0.15 index score
Standard Deviation 0.26
|
-0.19 index score
Standard Deviation 0.22
|
0.10 index score
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: within 1 week post treatmentPopulation: 1 participant from control group was unable to be analyzed due to loss of follow up.
Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from "-1" (or -100%) indicating left-hemispheric lateralization to "1" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).
Outcome measures
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=6 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Immediate Follow Up
|
0.10 index score
Standard Deviation 0.31
|
0.06 index score
Standard Deviation 0.47
|
-0.03 index score
Standard Deviation 0.46
|
-0.03 index score
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: 3 months post treatmentPopulation: 1 participant from control group was unable to be analyzed due to loss of follow up.
Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from "-1" (or -100%) indicating left-hemispheric lateralization to "1" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).
Outcome measures
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=6 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Long-term Follow Up
|
0.21 index score
Standard Deviation 0.20
|
-0.11 index score
Standard Deviation 0.14
|
-0.02 index score
Standard Deviation 0.29
|
0.23 index score
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Baseline: 1 week before the first nerTMS treatmentPopulation: 1 participant from control group was unable to be analyzed due to loss of follow up.
Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from "-1" (or -100%) indicating left-hemispheric lateralization to "1" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).
Outcome measures
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=6 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Baseline
|
-0.24 index score
Standard Deviation 0.23
|
-0.05 index score
Standard Deviation 0.47
|
-0.09 index score
Standard Deviation 0.33
|
-0.23 index score
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: within 1 week post treatmentPopulation: 1 participant from control group was unable to be analyzed due to loss of follow up.
Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from "-1" (or -100%) indicating left-hemispheric lateralization to "1" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).
Outcome measures
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=6 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Immediate Follow Up
|
0.06 index score
Standard Deviation 0.26
|
-0.22 index score
Standard Deviation 0.35
|
0.01 index score
Standard Deviation 0.39
|
-0.33 index score
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: 3 months post treatmentPopulation: 1 participant from control group was unable to be analyzed due to loss of follow up.
Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from "-1" (or -100%) indicating left-hemispheric lateralization to "1" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).
Outcome measures
| Measure |
rTMS
n=7 Participants
3 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
1 Week of Sham Treatment + 2 Weeks of nerTMS
n=7 Participants
1 week of Sham Treatment + 2 weeks of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
2 Weeks of Sham Treatment +1 Week of nerTMS
n=7 Participants
2 weeks of Sham Treatment +1 week of nerTMS
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
Control Group
n=6 Participants
3 weeks of Sham Treatment
Magstim SuperRapid: This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
|
|---|---|---|---|---|
|
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Long-term Follow Up
|
-0.08 index score
Standard Deviation 0.35
|
0.02 index score
Standard Deviation 0.21
|
0.08 index score
Standard Deviation 0.20
|
-0.28 index score
Standard Deviation 0.21
|
Adverse Events
rTMS
1 Week of Sham Treatment + 2 Weeks of nerTMS
2 Weeks of Sham Treatment +1 Week of nerTMS
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jerzy P. Szaflarski
Universtiy of Alabama at Birmingham
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place