Transcranial Direct-Current Stimulation (tCDS) and Robotics for Children With Hemiplegia

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Cerebral Palsy, Hemiplegia

In brief

Hemiplegia occurs when the function of motor areas in the brain become impaired, predominantly unilaterally, during perinatal development. Children with hemiplegia show impairments in motor control of the affected side of the body. Impairments in use of the upper extremity are common, and lead to functional disability throughout the lifespan of a person with hemiplegia. Upper extremity impairments can severely affect a person's ability to carry out activities of daily living. The goal of this study at Blythedale Children's Hospital is to test the efficacy of transcranial direct current stimulation (tDCS) and robotic upper extremity therapy in improving upper extremity function in children with unilateral cerebral palsy. This study will test the hypothesis that physical rehabilitation, provided by repetitive arm movements guided by a robot, will improve upper extremity function in children with hemiplegia, and that this improvement can be enhanced by transcranial direct current stimulation of motor cortex immediately before robotic training.

Key facts

Study ID

NCT03145532

Run by

Blythedale Children's Hospital

People needed

40

Starts

2017-06-12

Expected to finish

2023-06-01

Last updated by the study team

2022-01-10

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 6-17
• Participant and caregiver willing and able to provide informed consen/assent
• Diagnosis of hemiplegia
• Joint mobility: wrist extension, 20º, metacarpophalangeal and proximal interphalangeal joints 10º

You may not qualify if…

• Cognitive deficits that impede understanding of study protocol
• Current medical illness unrelated to CP
• Visual problems (uncorrected by glasses/contact lenses)
• High motor ability in affected arm Pre-intervention screening measures; Motor activity log, score > 2.5 ( > slight-to-moderate)
• Severe spasticity Pre-intervention screening measures; Modified Ashworth test, score > 3 ( > moderate)
• Lack of asymmetry in hand function
• Orthopedic surgery in affected arm within 2 years
• Dorsal root rhizotomy
• Botulinum toxin therapy in either upper extremity during last 2 months, or planned during study period
• Currently receiving intrathecal baclofen
• Seizure beyond age 2, use of anti-seizure medication, history of epilepsy (in self or first degree relatives), brain surgery, cranial metal implants, structural brain lesion, devices that may be affected by TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
• True positive response on the Transcranial Magnetic Stimulation Safety Screen
• Current use of medications known to lower the seizure threshold
• Previous episode of neurocardiogenic syncopy

Where it is running

• Kathleen Friel — Valhalla, New York, United States

Full record on ClinicalTrials.gov

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