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Structurally Reorganizing Motor Cortex in Stroke Patients Through Hebbian-type Stimulation

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ClinicalTrials.gov Identifier: NCT01569607
Recruitment Status : Completed
First Posted : April 3, 2012
Results First Posted : January 16, 2018
Last Update Posted : January 16, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Cathrin Buetefisch, Emory University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Stroke
Interventions: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Device: Sham stimulation

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited between March 2012 and August 2016.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants completed the eligibility phase prior to being randomized to a study arm. Of the 48 participants that provided consent, 22 were eligible for participation and were randomized to an intervention.

Reporting Groups
  Description
Hebbian-type Stimulation

Participants were randomized to receive motor training with Hebbian-type stimulation.

Repetitive Transcranial Magnetic Stimulation (rTMS): Training sessions for 5 days in a row

Sham Stimulation

Participants were randomized to receive sham stimulation.

Sham stimulation: Sham stimulation


Participant Flow:   Overall Study
    Hebbian-type Stimulation   Sham Stimulation
STARTED   11   11 
COMPLETED   10   10 
NOT COMPLETED   1   1 



  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.
Participants that were randomized to a study arm and received an intervention.

Reporting Groups
  Description
Hebbian-type Stimulation

Participants were randomized to receive motor training with Hebbian-type stimulation.

Repetitive Transcranial Magnetic Stimulation (rTMS): Training sessions for 5 days in a row

Sham Stimulation

Participants were randomized to receive sham stimulation.

Sham stimulation: Sham stimulation

Total Total of all reporting groups

Baseline Measures
   Hebbian-type Stimulation   Sham Stimulation   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   11   22 
Age 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 11   11   22 
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      7  63.6%      6  54.5%      13  59.1% 
>=65 years      4  36.4%      5  45.5%      9  40.9% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 11   11   22 
Female      6  54.5%      5  45.5%      11  50.0% 
Male      5  45.5%      6  54.5%      11  50.0% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 0   0   0 
         0 
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States       
Participants Analyzed 
[Units: Participants]
 11   11   22 
United States   11   11   22 


  Outcome Measures

1.  Primary:   Primary Motor Cortex (M1) Excitability Derived From Stimulus Response Curve   [ Time Frame: Baseline, Post-Training 1 (1 Week), Post-Training 2 (4 Weeks) ]

2.  Secondary:   Mean Time to Completion for Jebsen Hand Function Test (JTT)   [ Time Frame: Baseline, Post-Training (1 Week), Post-Training (4 Weeks) ]

3.  Secondary:   Mean Peak Acceleration of Wrist Extension Movements   [ Time Frame: Baseline, Post-Training (1 Week), Post-Training (4 Weeks) ]

4.  Secondary:   Mean Reaction Time of Wrist Extension Movements   [ Time Frame: Baseline, Post-Training (1 Week), Post-Training (4 Weeks) ]

5.  Secondary:   Mean Motor Activity Log (MAL) Score: Amount Subtest   [ Time Frame: Baseline, Post-Training (1 Week), Post-Training (4 Weeks) ]

6.  Secondary:   Mean Motor Activity Log (MAL): How Well Subtest   [ Time Frame: Baseline, Post-Training (1 Week), Post-Training (4 Weeks) ]

7.  Secondary:   Mean Wolf Motor Function Test (WMFT) Total Time   [ Time Frame: Baseline, Post-Training (1 Week), Post-Training (4 Weeks) ]

8.  Secondary:   Mean Wolf Motor Function Test Functional Ability (WMFT-FS) Scale Score   [ Time Frame: Baseline, Post-Training (1 Week), Post-Training (4 Weeks) ]

9.  Secondary:   Mean Wolf Motor Function Test (WMFT) Grip Strength   [ Time Frame: Baseline, Post-Training (1 Week), Post-Training (4 Weeks) ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Cathrin Buetefisch
Organization: Emory University
phone: 404-712-5507
e-mail: cathrin.buetefisch@emory.edu



Responsible Party: Cathrin Buetefisch, Emory University
ClinicalTrials.gov Identifier: NCT01569607     History of Changes
Other Study ID Numbers: IRB00052053
R21HD067906-01A1 ( U.S. NIH Grant/Contract )
SRMC21 ( Other Identifier: Other )
First Submitted: March 30, 2012
First Posted: April 3, 2012
Results First Submitted: October 31, 2017
Results First Posted: January 16, 2018
Last Update Posted: January 16, 2018