Trial Outcomes & Findings for TMS in Aphasia Recovery (NCT NCT04777214)
NCT ID: NCT04777214
Last Updated: 2021-11-26
Results Overview
The Boston Naming Test is an assessment of confrontation naming, where a score ranges from 0 (no items named correctly) to 36 (all items named correctly)
COMPLETED
NA
24 participants
Baseline, 2 months and 6-months after the last rTMS treatment session
2021-11-26
Participant Flow
Patients were assessed against the study inclusion and exclusion criteria. Eligible patients then underwent language tests before and after 6 ten minute sessions of rTMS to determine if there was a right hemisphere cortical region which, when suppressed with 1 Hz rTMS, resulted in significantly improved naming. If no benefit was observed from stimulation, the patient did not continue on to the treatment phase.
Participant milestones
| Measure |
Active TMS
There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS are delivered to a previously determined optimal response site in right frontal lobe.
Repetitive Transcranial Magnetic Stimulation: Active TMS will be at 90% motor threshold
|
Sham TMS
There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz TMS are delivered, however, the coil will be rotated 90 degrees during stimulation.
Sham TMS: Sham TMS will be administered
at least 2 months later, patients then receive Active TMS if they so choose. There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS are delivered to a previously determined optimal response site in right frontal lobe.
Repetitive Transcranial Magnetic Stimulation: Active TMS will be at 90% motor threshold
|
|---|---|---|
|
Initial Randomization
STARTED
|
5
|
5
|
|
Initial Randomization
COMPLETED
|
5
|
5
|
|
Initial Randomization
NOT COMPLETED
|
0
|
0
|
|
Sham Crossover to Active TMS Arm
STARTED
|
0
|
5
|
|
Sham Crossover to Active TMS Arm
COMPLETED
|
0
|
5
|
|
Sham Crossover to Active TMS Arm
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TMS in Aphasia Recovery
Baseline characteristics by cohort
| Measure |
Active TMS
n=5 Participants
There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS are delivered to a previously determined optimal response site in right frontal lobe.
Repetitive Transcranial Magnetic Stimulation: Active TMS will be at 90% motor threshold
|
Sham TMS
n=5 Participants
There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz TMS are delivered, however, the coil will be rotated 90 degrees during stimulation.
Sham TMS: Sham TMS will be administered
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 7.09 • n=5 Participants
|
62.6 years
STANDARD_DEVIATION 10.14 • n=7 Participants
|
61.6 years
STANDARD_DEVIATION 8.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 months and 6-months after the last rTMS treatment sessionPopulation: 9 participants completed the Active TMS arm and were available for follow-up at 2- and 6- months post treatment.
The Boston Naming Test is an assessment of confrontation naming, where a score ranges from 0 (no items named correctly) to 36 (all items named correctly)
Outcome measures
| Measure |
Active TMS 2-month Follow-Up
n=9 Participants
There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS are delivered to a previously determined optimal response site in right frontal lobe.
Repetitive Transcranial Magnetic Stimulation: Active TMS will be at 90% motor threshold
Outcome measures are then assessed 2 months after TMS treatment sessions.
|
Active TMS 6-month Follow-Up
n=9 Participants
There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS are delivered to a previously determined optimal response site in right frontal lobe.
Repetitive Transcranial Magnetic Stimulation: Active TMS will be at 90% motor threshold
Outcome measures are then assessed 6 months after TMS treatment sessions.
|
|---|---|---|
|
Boston Naming Test
|
10.3 percent change from baseline
Standard Deviation 20.0
|
37.7 percent change from baseline
Standard Deviation 31.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 2 months after the last rTMS treatment sessionPopulation: Comparison of total narrative word output change between baseline and 2-months between Active arm and Sham Arm. Active TMS arm includes both 5 participants initially randomized to Active TMS arm, plus 5 people who crossed over to Active arm after Sham arm.
The picture description of the Boston Diagnostic Aphasia Exam is a measurement of spontaneous speech, elicited by a picture description. It is not a scale. Quantitative Production Analysis (QPA) is used to analyze the production of words related to the picture stimulus. Total number of Narrative Words produced, defined as total words minus stereotyped utterances, task-related comments, or comments cued by administrator, was determined using QPA as a measure of discourse productivity.
Outcome measures
| Measure |
Active TMS 2-month Follow-Up
n=10 Participants
There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS are delivered to a previously determined optimal response site in right frontal lobe.
Repetitive Transcranial Magnetic Stimulation: Active TMS will be at 90% motor threshold
Outcome measures are then assessed 2 months after TMS treatment sessions.
|
Active TMS 6-month Follow-Up
n=5 Participants
There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS are delivered to a previously determined optimal response site in right frontal lobe.
Repetitive Transcranial Magnetic Stimulation: Active TMS will be at 90% motor threshold
Outcome measures are then assessed 6 months after TMS treatment sessions.
|
|---|---|---|
|
Picture Description of the Boston Diagnostic Aphasia Exam
|
10.4 change in number of words from baseline
Standard Deviation 16.3
|
1.2 change in number of words from baseline
Standard Deviation 15.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 2 months after the last rTMS treatment sessionPopulation: Comparison of percent change in outcome between baseline and 2-months between Active arm and Sham Arm. Active TMS arm includes both 5 participants initially randomized to Active TMS arm, plus 5 people who crossed over to Active arm after Sham arm.
The Boston Diagnostic Aphasia Exam - Word Discrimination Subtest is an assessment of auditory comprehension via word discrimination, where a score ranges from 0 (no items correct) to 72 (all items correct)
Outcome measures
| Measure |
Active TMS 2-month Follow-Up
n=10 Participants
There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS are delivered to a previously determined optimal response site in right frontal lobe.
Repetitive Transcranial Magnetic Stimulation: Active TMS will be at 90% motor threshold
Outcome measures are then assessed 2 months after TMS treatment sessions.
|
Active TMS 6-month Follow-Up
n=5 Participants
There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS are delivered to a previously determined optimal response site in right frontal lobe.
Repetitive Transcranial Magnetic Stimulation: Active TMS will be at 90% motor threshold
Outcome measures are then assessed 6 months after TMS treatment sessions.
|
|---|---|---|
|
Boston Diagnostic Aphasia Exam - Word Discrimination Subtest
|
1.78 Percent change from baseline
Standard Deviation 6.83
|
0.32 Percent change from baseline
Standard Deviation 1.51
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 2 months after the last rTMS treatmentPopulation: Comparison of percent change in outcome between baseline and 2-months between Active arm and Sham Arm. Active TMS arm includes both 5 participants initially randomized to Active TMS arm, plus 5 people who crossed over to Active arm after Sham arm.
The Boston Diagnostic Aphasia Examination - Commands Subtest is an assessment of auditory comprehension via command following, where a score ranges from 0 (no items correctly performed) to 15 (all items correctly performed). Percent change was calculated by taking the mean performance at 2-months after rTMS treatment and subtracting mean performance at baseline, then dividing by the mean baseline performance and multiplying by 100.
Outcome measures
| Measure |
Active TMS 2-month Follow-Up
n=10 Participants
There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS are delivered to a previously determined optimal response site in right frontal lobe.
Repetitive Transcranial Magnetic Stimulation: Active TMS will be at 90% motor threshold
Outcome measures are then assessed 2 months after TMS treatment sessions.
|
Active TMS 6-month Follow-Up
n=5 Participants
There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS are delivered to a previously determined optimal response site in right frontal lobe.
Repetitive Transcranial Magnetic Stimulation: Active TMS will be at 90% motor threshold
Outcome measures are then assessed 6 months after TMS treatment sessions.
|
|---|---|---|
|
Boston Diagnostic Aphasia Examination - Commands Subtest
|
2.22 percent change from baseline
Standard Deviation 12.08
|
8.00 percent change from baseline
Standard Deviation 10.26
|
Adverse Events
Active TMS
Sham TMS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place