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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01636661
Recruitment Status : Completed
First Posted : July 10, 2012
Results First Posted : July 20, 2015
Last Update Posted : November 9, 2015
Sponsor:
Collaborator:
Minnesota Medical Foundation
Information provided by (Responsible Party):
University of Minnesota

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hemiparesis
Intervention Device: tDCS
Enrollment 13
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Transcranial Direct Current Stimulation Sham tDCS
Hide Arm/Group Description

Receiving active tDCS

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

tDCS equipment set to placebo setting.

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

Period Title: Overall Study
Started 5 6
Completed 5 6
Not Completed 0 0
Arm/Group Title Transcranial Direct Current Stimulation Sham tDCS Total
Hide Arm/Group Description

Receiving active tDCS

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

tDCS equipment set to placebo setting.

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

Total of all reporting groups
Overall Number of Baseline Participants 5 6 11
Hide Baseline Analysis Population Description
Pilot study estimating a sample of children with hemiparesis. No formal sample size nor power analysis was performed.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 11 participants
<=18 years
5
 100.0%
6
 100.0%
11
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 6 participants 11 participants
10.7  (3.2) 16.9  (2.6) 14.7  (3.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 11 participants
Female
2
  40.0%
3
  50.0%
5
  45.5%
Male
3
  60.0%
3
  50.0%
6
  54.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 6 participants 11 participants
5 6 11
1.Primary Outcome
Title Adverse Events/Safety Assessment.
Hide Description

Assessment of safety of use of tDCS in children with hemiparesis through vital signs, physician evaluation, subject report of symptoms. Reported are the number of participants who met the following criteria:

  1. Vital Signs (either resting blood pressure or heart rate)- Any greater than 2SD of change in vital signs from pretest to posttest.
  2. Physician Evaluation- Child identified as declining in function from pretest to posttest.
  3. Subject Report of Symptoms- Reports of serious adverse event/symptoms from pretest to posttest.

Detailed adverse events are reported in the adverse events module.

Time Frame Baseline, Posttest, Follow-Up Session at One-Week
Hide Outcome Measure Data
Hide Analysis Population Description
Pilot study therefore no sample size analysis. Completed per protocol.
Arm/Group Title Transcranial Direct Current Stimulation Sham tDCS
Hide Arm/Group Description:

Receiving active tDCS

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

tDCS equipment set to placebo setting.

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

Overall Number of Participants Analyzed 5 6
Measure Type: Number
Unit of Measure: Participants
Any Change in Vital Signs 0 0
Decline in Physician Evaluation 0 0
Reported Serious Adverse Events 0 0
2.Secondary Outcome
Title Hand Function Decline as Measured by Number of Participants
Hide Description Measured by the Box and Blocks Test and Grip Strength
Time Frame Baseline, Posttest, Follow-Up Session at One-Week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transcranial Direct Current Stimulation Sham tDCS
Hide Arm/Group Description:

Receiving active tDCS

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

tDCS equipment set to placebo setting.

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

Overall Number of Participants Analyzed 5 6
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transcranial Direct Current Stimulation Sham tDCS
Hide Arm/Group Description

Receiving active tDCS

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

tDCS equipment set to placebo setting.

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

All-Cause Mortality
Transcranial Direct Current Stimulation Sham tDCS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Transcranial Direct Current Stimulation Sham tDCS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/6 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Transcranial Direct Current Stimulation Sham tDCS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      4/6 (66.67%)    
Nervous system disorders     
Sleepiness *  0/5 (0.00%)  0 3/6 (50.00%)  3
Skin and subcutaneous tissue disorders     
Itching * [1]  1/5 (20.00%)  1 0/6 (0.00%)  0
Burning *  0/5 (0.00%)  0 1/6 (16.67%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Reports of tingling under the electrodes. Assessed verbally by participant feedback at scheduled intervals: pre/post and follow-up sessions.
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
Layout table for Results Point of Contact information
Name/Title: Dr. Bernadette Gillick
Organization: University of Minnesota
Phone: 612.626.6415
EMail: brown029@umn.edu
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01636661    
Other Study ID Numbers: 1205M13901
First Submitted: June 11, 2012
First Posted: July 10, 2012
Results First Submitted: June 22, 2015
Results First Posted: July 20, 2015
Last Update Posted: November 9, 2015