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Repetitive transcranial magnetic stimulation induced virtual lesions for aphasia.
To evaluate the effect of navigated repetitive transcranial magnetic stimulation in subjects with aphasia after stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Middle temporal gyrus | Experimental | Repetitive magnetic stimulation to middle temporal gyrus |
|
| Control group | Sham Comparator | Repetitive magnetic stimulation (Sham) |
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| Superior temporal gyrus | Experimental | Repetitive magnetic stimulation to superior temporal gyrus |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive magnetic stimulation to superior temporal gyrus | Device | Repetitive magnetic stimulation to superior temporal gyrus |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change of Reaction Time Between Before and After Stimulation in Each Session (MTG, STG, Sham) | 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 | change between before and after the TMS stimulation for each sessions (at session 1, session 2, session 3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nam-Jong Paik, MD, PhD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Bundang-gu | 463-707 | South Korea |
15 participants recruited: 15 screened, 0 excluded, 3 participants dropped out (3 participants withdrew because of their long-distance commute before group assignment)
recruitment period : 2012.12.05-2013.03.07 type of location: medical clinic through public announcement
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Session of Stimulation |
|
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| Repetitive magnetic stimulation to middle temporal gyrus | Device | Repetitive magnetic stimulation to middle temporal gyrus |
|
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| Repetitive magnetic stimulation (Sham) | Device | Repetitive magnetic stimulation (Sham) |
|
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| COMPLETED |
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| NOT COMPLETED |
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| Washout (at Least 3 Days) |
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| Second Session of Stimulation |
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| Washout (at Least 3 Days) |
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| Third Session of Stimulation |
|
Same patients were stimulated over 2 different regions and with sham stimulation in a random order
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Change of Reaction Time Between Before and After Stimulation in Each Session (MTG, STG, Sham) | 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 | Posted | Mean | Standard Deviation | msec | change between before and after the TMS stimulation for each sessions (at session 1, session 2, session 3) |
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|
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during the stimulation and till the end of study participation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Middle Temporal Gyrus | Repetitive magnetic stimulation to middle temporal gyrus Repetitive magnetic stimulation to middle temporal gyrus: Repetitive magnetic stimulation to middle temporal gyrus | 0 | 12 | 0 | 12 | ||
| EG001 | Control Group | Repetitive magnetic stimulation (Sham) Repetitive magnetic stimulation (Sham): Repetitive magnetic stimulation (Sham) | 0 | 12 | 0 | 12 | ||
| EG002 | Superior Temporal Gyrus | Repetitive magnetic stimulation to superior temporal gyrus Repetitive magnetic stimulation to superior temporal gyrus: Repetitive magnetic stimulation to superior temporal gyrus | 0 | 12 | 0 | 12 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nam-Jong Paik | Seoul National University Bundang Hospital | 031-787-7731 | 7731 | njpaik@snu.ac.kr |