Trial Outcomes & Findings for Effects of Navigated Repetitive Transcranial Magnetic Stimulation According to Post-stroke Aphasia Types (NCT NCT01877161)
NCT ID: NCT01877161
Last Updated: 2017-07-31
Results Overview
Reaction time for lexical and repetition test were measured before and after the TMS stimulation at each sessions (at session 1, session 2, session 3 over MTG/STG/Sham; MTG: middle temporal gyrus, STG: superior temporal gyrus). Response times were measured via the response pad, and spoken responses were recorded via a SV-1 Voice Key apparatus. The "reaction time post TMS - reaction time pre TMS" were used for analysis.\* Arm/Group Title Arm/Group Description Maximum length (999) Repetitive magnetic stimulation (rTMS) were applied over STG
COMPLETED
NA
12 participants
change between before and after the TMS stimulation for each sessions (at session 1, session 2, session 3)
2017-07-31
Participant Flow
recruitment period : 2012.12.05-2013.03.07 type of location: medical clinic through public announcement
15 participants recruited: 15 screened, 0 excluded, 3 participants dropped out (3 participants withdrew because of their long-distance commute before group assignment)
Participant milestones
| Measure |
rTMS Over MTG, STG, Sham
3 sessions of Repetitive magnetic stimulation (rTMS) were applied to participants 3 sessions of rTMS were determined by a random sequence (eg. middle temporal gyrus (MTG)-superior temporal gyrus (STG)-Sham, Sham-MTG-STG, STG-MTG-Sham etc..0) The sequence of stimulation was counter-balanced across subjects.
different sessions was performed after washout period (at least 3 days). The coil was placed perpendicularly to the scalp during sham rTMS sessions.
|
|---|---|
|
First Session of Stimulation
STARTED
|
12
|
|
First Session of Stimulation
COMPLETED
|
12
|
|
First Session of Stimulation
NOT COMPLETED
|
0
|
|
Washout (at Least 3 Days)
STARTED
|
12
|
|
Washout (at Least 3 Days)
COMPLETED
|
12
|
|
Washout (at Least 3 Days)
NOT COMPLETED
|
0
|
|
Second Session of Stimulation
STARTED
|
12
|
|
Second Session of Stimulation
COMPLETED
|
12
|
|
Second Session of Stimulation
NOT COMPLETED
|
0
|
|
Third Session of Stimulation
STARTED
|
12
|
|
Third Session of Stimulation
COMPLETED
|
12
|
|
Third Session of Stimulation
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Navigated Repetitive Transcranial Magnetic Stimulation According to Post-stroke Aphasia Types
Baseline characteristics by cohort
| Measure |
rTMS Over MTG, STG, Sham
n=15 Participants
3 sessions of Repetitive magnetic stimulation (rTMS) were applied to participants.
3 sessions of rTMS were determined by a random sequence (eg. MTG-STG-Sham, Sham-MTG-STG, STG-MTG-Sham etc.) MTG: middle temporal gyrus STG: superior temporal gyrus
The sequence of stimulation was counter-balanced across subjects. different sessions was performed after washout period (at least 3 days). The coil was placed perpendicularly to the scalp during sham rTMS sessions.
|
|---|---|
|
Age, Continuous
|
31.87 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: change between before and after the TMS stimulation for each sessions (at session 1, session 2, session 3)Reaction time for lexical and repetition test were measured before and after the TMS stimulation at each sessions (at session 1, session 2, session 3 over MTG/STG/Sham; MTG: middle temporal gyrus, STG: superior temporal gyrus). Response times were measured via the response pad, and spoken responses were recorded via a SV-1 Voice Key apparatus. The "reaction time post TMS - reaction time pre TMS" were used for analysis.\* Arm/Group Title Arm/Group Description Maximum length (999) Repetitive magnetic stimulation (rTMS) were applied over STG
Outcome measures
| Measure |
rTMS Over MTG
n=12 Participants
Repetitive magnetic stimulation (rTMS) were applied over MTG
|
rTMS Over STG
n=12 Participants
Repetitive magnetic stimulation (rTMS) were applied over STG
|
Sham rTMS
n=12 Participants
The coil was placed perpendicularly to the scalp during sham rTMS sessions.
|
|---|---|---|---|
|
The Change of Reaction Time Between Before and After Stimulation in Each Session (MTG, STG, Sham)
|
110.65 msec
Standard Deviation 102.97
|
-14.25 msec
Standard Deviation 105.78
|
25.29 msec
Standard Deviation 109.74
|
Adverse Events
Middle Temporal Gyrus
Control Group
Superior Temporal Gyrus
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Nam-Jong Paik
Seoul National University Bundang Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place