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NCT Number: NCT03402854

tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Hemiplegia Hemiplegic Cerebral Palsy Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Spastic Hemiparesis Spastic Hemiplegia Spastic Hemiplegic Cerebral Palsy

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Burke Medical Research Institute

White Plains, New York, 10605, United States

Location status: Recruiting

Location contact

Andrew M Gordon, PhD

SUB_INVESTIGATOR

Kathleen M Friel, PhD

CONTACT

[email protected]

914-368-3116

Kathleen M Friel, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Transcranial Direct Current Stimulation

Device

Participants will receive 20 min of tDCS over the scalp during the first 20 min of bimanual training.

bimanual training

Behavioral

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

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Kathleen M Friel, PhD

CONTACT

[email protected]

914-368-3116

Sponsors and collaborators

Lead sponsor

Burke Medical Research Institute

Other

Collaborators

  • Teachers College, Columbia University
  • University of Minnesota

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jan 18, 2018
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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