To Healthy Volunteer, Virtual Lesions for Aphasia
Conditions
Brief summary
Repetitive transcranial magnetic stimulation induced virtual lesions for aphasia.
Detailed description
To evaluate the effect of navigated repetitive transcranial magnetic stimulation in subjects with aphasia after stroke.
Interventions
DEVICERepetitive magnetic stimulation to superior temporal gyrus
Repetitive magnetic stimulation to superior temporal gyrus
DEVICERepetitive magnetic stimulation to middle temporal gyrus
Repetitive magnetic stimulation to middle temporal gyrus
DEVICERepetitive magnetic stimulation (Sham)
Repetitive magnetic stimulation (Sham)
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* fluent in Korean * older than 18 years old
Exclusion criteria
* younger than 18 years old * psychotic or psychiatric problems * pregnant * contraindications to MRI/fMRI * uncooperative * metalic implants, pacemaker or cochlear implants * cannot perform outcome measure-related task * known seizure history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change of Reaction Time Between Before and After Stimulation in Each Session (MTG, STG, Sham) | 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 |
Countries
South Korea
Participant flow
Recruitment details
recruitment period : 2012.12.05-2013.03.07 type of location: medical clinic through public announcement
Pre-assignment details
15 participants recruited: 15 screened, 0 excluded, 3 participants dropped out (3 participants withdrew because of their long-distance commute before group assignment)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | rTMS Over MTG, STG, Sham |
|---|---|
| Age, Continuous | 31.87 years |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
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
Time frame: change between before and after the TMS stimulation for each sessions (at session 1, session 2, session 3)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rTMS Over MTG | The Change of Reaction Time Between Before and After Stimulation in Each Session (MTG, STG, Sham) | 110.65 msec | Standard Deviation 102.97 |
| rTMS Over STG | The Change of Reaction Time Between Before and After Stimulation in Each Session (MTG, STG, Sham) | -14.25 msec | Standard Deviation 105.78 |
| Sham rTMS | The Change of Reaction Time Between Before and After Stimulation in Each Session (MTG, STG, Sham) | 25.29 msec | Standard Deviation 109.74 |