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Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis (tDCS)

This study has been completed.
Sponsor:
Collaborator:
Minnesota Medical Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01636661
First received: June 11, 2012
Last updated: October 7, 2015
Last verified: October 2015
Results First Received: June 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hemiparesis
Intervention: Device: tDCS

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
If a child did not exhibit a motor evoked potential from the ipsilesional cortex, they were excluded from the trial after enrollment but before assignment to a group.

Reporting Groups
  Description
Transcranial Direct Current Stimulation

Receiving active tDCS

tDCS: transcranial direct current stimulation- non-invasive brain stimulation

Sham tDCS

tDCS equipment set to placebo setting.

tDCS: transcranial direct current stimulation- non-invasive brain stimulation


Participant Flow:   Overall Study
    Transcranial Direct Current Stimulation     Sham tDCS  
STARTED     5     6  
COMPLETED     5     6  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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.
Pilot study estimating a sample of children with hemiparesis. No formal sample size nor power analysis was performed.

Reporting Groups
  Description
Transcranial Direct Current Stimulation

Receiving active tDCS

tDCS: transcranial direct current stimulation- non-invasive brain stimulation

Sham tDCS

tDCS equipment set to placebo setting.

tDCS: transcranial direct current stimulation- non-invasive brain stimulation

Total Total of all reporting groups

Baseline Measures
    Transcranial Direct Current Stimulation     Sham tDCS     Total  
Number of Participants  
[units: participants]
  5     6     11  
Age  
[units: participants]
     
<=18 years     5     6     11  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Median (Standard Deviation)
  10.7  (3.2)     16.9  (2.6)     14.7  (3.5)  
Gender  
[units: participants]
     
Female     2     3     5  
Male     3     3     6  
Region of Enrollment  
[units: participants]
     
United States     5     6     11  



  Outcome Measures
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1.  Primary:   Adverse Events/Safety Assessment.   [ Time Frame: Baseline, Posttest, Follow-Up Session at One-Week ]

2.  Secondary:   Hand Function Decline as Measured by Number of Participants   [ Time Frame: Baseline, Posttest, Follow-Up Session at One-Week ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: Dr. Bernadette Gillick
Organization: University of Minnesota
phone: 612.626.6415
e-mail: brown029@umn.edu


Publications of Results:

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01636661     History of Changes
Other Study ID Numbers: 1205M13901
Study First Received: June 11, 2012
Results First Received: June 22, 2015
Last Updated: October 7, 2015
Health Authority: United States: Institutional Review Board