tDCS and Robotic Training in Adults With Cerebral Palsy

Burke Medical Research Institute

Status: Active, not recruiting

Conditions: Cerebral Palsy; Hemiplegia

Treatments: Behavioral: Upper Extremity Robotics, tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03038269

BRC 467

Details and patient eligibility

About

The purpose of this study is to improve arm function in adults with hemiplegic cerebral palsy. Participants will receive transcranial direct current stimulation (or sham) in combination with upper extremity robotic therapy.

Full description

Therapy consists of 20 minutes of non-invasive, low-level brain stimulation (transcranial direct current stimulation, tDCS), followed by one hour of shoulder/wrist robotic training. Participants will be enrolled in therapy 3 times per week for 12 weeks (or 36 sessions). Before and after therapy, participants will receive and assessment of their arm function, as well as an assessment of their brain activity, using electroencephalography (EEG) and transcranial magnetic stimulation (TMS).

Enrollment: 22 estimated patients

Sex: All

Ages: 15 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant willing and able to provide informed consent
• Diagnosis of hemiplegic Cerebral Palsy
• Joint mobility: wrist extention (20 degrees), metacarophalangeal and proximal interphalangeal joints (10 degrees)

Exclusion criteria

• 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
• Severe spasticity
• 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, deices 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 snycopy

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups

Sham tDCS

Sham Comparator group

Description:

Participant will receive a placebo-type stimulation followed by upper extremity robotic training.

Treatment:

Behavioral: Upper Extremity Robotics, tDCS

Active tDCS

Active Comparator group

Description:

Participant will receive active transcranial direct current stimulation followed by upper extremity robotic training.

Treatment:

Behavioral: Upper Extremity Robotics, tDCS