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Effects of Navigated Repetitive Transcranial Magnetic Stimulation According to Post-stroke Aphasia Types

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ClinicalTrials.gov Identifier: NCT01877161
Recruitment Status : Completed
First Posted : June 13, 2013
Results First Posted : June 4, 2014
Last Update Posted : July 31, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions: To Healthy Volunteer
Virtual Lesions for Aphasia
Interventions: Device: Repetitive magnetic stimulation to superior temporal gyrus
Device: Repetitive magnetic stimulation to middle temporal gyrus
Device: Repetitive magnetic stimulation (Sham)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
recruitment period : 2012.12.05-2013.03.07 type of location: medical clinic through public announcement

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
15 participants recruited: 15 screened, 0 excluded, 3 participants dropped out (3 participants withdrew because of their long-distance commute before group assignment)

Reporting Groups
  Description
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.


Participant Flow for 5 periods

Period 1:   First Session of Stimulation
    rTMS Over MTG, STG, Sham
STARTED   12 
COMPLETED   12 
NOT COMPLETED   0 

Period 2:   Washout (at Least 3 Days)
    rTMS Over MTG, STG, Sham
STARTED   12 
COMPLETED   12 
NOT COMPLETED   0 

Period 3:   Second Session of Stimulation
    rTMS Over MTG, STG, Sham
STARTED   12 
COMPLETED   12 
NOT COMPLETED   0 

Period 4:   Washout (at Least 3 Days)
    rTMS Over MTG, STG, Sham
STARTED   12 
COMPLETED   12 
NOT COMPLETED   0 

Period 5:   Third Session of Stimulation
    rTMS Over MTG, STG, Sham
STARTED   12 
COMPLETED   12 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Same patients were stimulated over 2 different regions and with sham stimulation in a random order

Reporting Groups
  Description
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.


Baseline Measures
   rTMS Over MTG, STG, Sham 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Years]
Mean (Full Range)
 31.87 
 (24 to 47) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  33.3% 
Male      10  66.7% 


  Outcome Measures

1.  Primary:   The Change of Reaction Time Between Before and After Stimulation in Each Session (MTG, STG, Sham)   [ Time Frame: change between before and after the TMS stimulation for each sessions (at session 1, session 2, session 3) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Nam-Jong Paik
Organization: Seoul National University Bundang Hospital
phone: 031-787-7731 ext 7731
e-mail: njpaik@snu.ac.kr



Responsible Party: Nam-Jong Paik, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01877161     History of Changes
Other Study ID Numbers: E-1206-158-003
First Submitted: March 11, 2013
First Posted: June 13, 2013
Results First Submitted: January 23, 2014
Results First Posted: June 4, 2014
Last Update Posted: July 31, 2017