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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04725019
• Other study ID #: 5825
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: July 31, 2026

Study information

• Verified date: January 2021
• Source: Boston University Charles River Campus
• Contact: Claudio L Ferre, PhD
• Phone: (617) 353-7489
• Email: clferre[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• active transcranial direct current stimulation
Participants will receive 20 min of tDCS over the scalp during 20 min of motor training.

Behavioral:
• Motor training
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston University Charles River Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Assisting Hand Assessment	Investigators will measure changes in how well the child uses both hands cooperatively for bimanual activities.	Day before intervention begins, compared to day after intervention ends (approximately 1 week)
Primary	Changes in the Box and Blocks test	Investigators will measure changes in the movement speed of the hands.	Day before intervention begins, compared to day after intervention ends (approximately 1 week)
Secondary	Changes in Motor-evoked Potential assessment	Investigators will measure change in measurements of cortical excitability using transcranial magnetic stimulation (TMS) from baseline to follow-up (1 week).	Day before intervention begins, compared to day after intervention ends (approximately 1 week)