tDCS and Robotic Training in Adults With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Transcranial Direct Current Stimulation and Robotic Training in Adults With Cerebral Palsy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03038269
• Other study ID #: BRC 467
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2013
• Est. completion date: December 2022

Study information

• Verified date: October 2022
• Source: Burke Medical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegia

Intervention

Behavioral:
• Upper Extremity Robotics, tDCS
Participant will receive 20 minutes of non-invasive brain stimulation followed by one hour of shoulder/wrist robotic training.

Locations

Country	Name	City	State
United States	Burke Medical Research Institute	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Burke Medical Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Friel KM, Lee P, Soles LV, Smorenburg ARP, Kuo HC, Gupta D, Edwards DJ. Combined transcranial direct current stimulation and robotic upper limb therapy improves upper limb function in an adult with cerebral palsy. NeuroRehabilitation. 2017;41(1):41-50. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment of Motor Recovery	Evaluates and measures recovery	1 Week
Secondary	Wolf Motor Function Test	Quantifies upper extremity motor ability through timed and functional tasks	1 Week
Secondary	Box and Blocks Test	Measures unilateral gross motor dexterity.	1 Week