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tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT03402854
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : December 9, 2020
Sponsor:
Collaborators:
University of Minnesota
Teachers College, Columbia University
Information provided by (Responsible Party):
Burke Medical Research Institute

Brief Summary:
The goal of this study is to test the efficacy of transcranial direct current stimulation combined with bimanual training on hand function in children with unilateral spastic cerebral palsy (USCP). Children who enroll in the protocol will be randomized to receive either sham (not stimulating) tDCS plus bimanual training, or active (stimulating) tDCS plus bimanual training.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Hemiplegic Cerebral Palsy Spastic Hemiplegic Cerebral Palsy Spastic Hemiparesis Spastic Hemiplegia Device: active transcranial direct current stimulation Behavioral: bimanual training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Children will be randomly allocated to one of two parallel arms of the study.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Participants and care providers will not be told of their group allocation. Participants in the sham group will receive a brief stimulation of the scalp, which will give them a feeling of being stimulated. This sham stimulation has been shown to effectively blind participants to group. Assessors will not be told the type of study being conducted.
Primary Purpose: Treatment
Official Title: tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active tDCS + bimanual training
In this arm, participants will engage in 120 min of bimanual training. Bimanual training involves using both hands to play with toys and games during the study. During the first 20 min of bimanual training, participants will receive active tDCS via sponges over the scalp.
Device: active transcranial direct current stimulation
Participants will receive 20 min of tDCS over the scalp during the first 20 min of bimanual training.

Behavioral: bimanual training
Participants will engage in movements that use both hands, by playing with toys and games.

Experimental: Sham tDCS + bimanual training
In this arm, participants will engage in 120 min of bimanual training. Bimanual training involves using both hands to play with toys and games during the study. During the first 20 min of bimanual training, participants will wear the tDCS device that is worn by the active tDCS group, but in the sham group, participants will not receive stimulation during this 20 min period.
Behavioral: bimanual training
Participants will engage in movements that use both hands, by playing with toys and games.




Primary Outcome Measures :
  1. Change in Assisting Hand Assessment [ Time Frame: Day before intervention begins, compared to day after intervention ends (six days after intervention begins) ]
    Measure of how well the child uses both hands cooperatively for bimanual activities


Secondary Outcome Measures :
  1. Jebsen-Taylor Test of Hand Function [ Time Frame: Day before intervention begins, compared to day after intervention ends (six days after intervention begins) ]
    Measure of movement speed of affected hand

  2. Box and Blocks test [ Time Frame: Day before intervention begins, compared to day after intervention ends (six days after intervention begins) ]
    Measure of movement speed of affected hand



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of congenital hemiplegic cerebral palsy
  • Ability to lift and grasp light objects with affected hand
  • Ability to extend wrist of affected hand 15 degrees
  • Ability to follow instructions and provide informed assent
  • Parent(s) able to provide informed consent

Exclusion Criteria:

  • Seizures after age 2 years
  • Spasticity medication within 6 months before study
  • Selective dorsal rhizotomy
  • Surgery in affected upper extremity within year before study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03402854


Contacts
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Contact: Kathleen M Friel, PhD 914-368-3116 kaf3001@med.cornell.edu

Locations
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United States, New York
Burke Medical Research Institute Recruiting
White Plains, New York, United States, 10605
Contact: Kathleen M Friel, PhD    914-368-3116    kaf3001@med.cornell.edu   
Principal Investigator: Kathleen M Friel, PhD         
Sub-Investigator: Andrew M Gordon, PhD         
Sponsors and Collaborators
Burke Medical Research Institute
University of Minnesota
Teachers College, Columbia University
Investigators
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Principal Investigator: Kathleen M Friel, PhD Burke Medical Research Institute
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Responsible Party: Burke Medical Research Institute
ClinicalTrials.gov Identifier: NCT03402854    
Other Study ID Numbers: tDCS_bimanual
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators will share IPD via the NIH Data Hub (DASH), which is sponsored by NICHD.
Time Frame: Data will be available when study is complete, and remain in DASH indefinitely.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Burke Medical Research Institute:
pediatric
children
non-invasive brain stimulation
transcranial direct current stimulation
bimanual training
hand training
Additional relevant MeSH terms:
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Muscle Spasticity
Paralysis
Cerebral Palsy
Hemiplegia
Paresis
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations