tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy
|
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03402854 |
|
Recruitment Status :
Recruiting
First Posted : January 18, 2018
Last Update Posted : August 15, 2022
|
Sponsor:
Burke Medical Research Institute
Collaborators:
University of Minnesota
Teachers College, Columbia University
Information provided by (Responsible Party):
Burke Medical Research Institute
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| 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 : | August 31, 2025 |
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 :
- 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 :
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 8 Years to 18 Years (Child, Adult) |
| 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
| Contact: Kathleen M Friel, PhD | 914-368-3116 | kaf3001@med.cornell.edu |
Locations
| 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
| Principal Investigator: | Kathleen M Friel, PhD | Burke Medical Research Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | August 15, 2022 |
| Last Verified: | August 2022 |
| 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. |
| 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:
|
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 |