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NCT Number: NCT04725019

Enhancing Motor Learning in Children With Cerebral Palsy Using Transcranial Direct-current Stimulation

The goal of this study is to test the effects of transcranial direct current stimulation (tDCS) on motor learning and brain plasticity in children with unilateral spastic cerebral palsy (USCP).

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Children between 6-17 years old who have been diagnosed with cerebral palsy, with the following joint mobility: wrist extension 20º, metacarpophalangeal and proximal interphalangeal joints 10º. Ability to cooperate and follow simple directions.

Exclusion criteria

  • Seizure beyond age 2, use of anti-seizure medication, history or family history of epilepsy, cranial metal implants, structural brain lesion, devices that may be affected by tDCS or TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
  • True positive response on the Transcranial Magnetic Stimulation and MRI Safety Screen
  • Current use of medications known to lower the seizure threshold
  • Previous episode of unprovoked neurocardiogenic syncope
  • Indwelling metal or incompatible medical devices
  • Centrally-acting medications including anti-seizure medications
  • Evidence of scalp disease or skin abnormalities
  • Current medical illness unrelated to CP
  • High motor ability in affected arm (i.e. no asymmetry in scores of hand function)
  • Severe spasticity
  • Lack of asymmetry in hand function
  • Orthopedic surgery in affected arm
  • Botulinum toxin therapy in either upper extremity during last 6 months, or planned during study period
  • Currently receiving intrathecal baclofen
  • History of broken arm (either arm) 1 year prior to study enrollment

Treatment and study plan

Active Transcranial Direct Current Stimulation

Device

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

motor training

Behavioral

Participants will engage in a high number of repetition of movements that use both hands while playing with toys and games. Training will be provided 20 min/day, for 5 consecutive days.

Primary outcomes

  1. Changes in the Assisting Hand Assessment

    Time frame: Day before intervention begins, compared to day after intervention ends (approximately 1 week)

    Investigators will measure changes in how well the child uses both hands cooperatively for bimanual activities.

  2. Changes in the Box and Blocks test

    Time frame: Day before intervention begins, compared to day after intervention ends (approximately 1 week)

    Investigators will measure changes in the movement speed of the hands.

Secondary outcomes

  1. Changes in Motor-evoked Potential assessment

    Time frame: Day before intervention begins, compared to day after intervention ends (approximately 1 week)

    Investigators will measure change in measurements of cortical excitability using transcranial magnetic stimulation (TMS) from baseline to follow-up (1 week).

Study contacts

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

Claudio L Ferre, PhD

CONTACT

[email protected]

(617) 353-7489

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2021
Registry last updated
Jan 26, 2021

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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