tDCS and Robotic Training in Adults With Cerebral Palsy

NCT ID: NCT03038269

Last Updated: 2022-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Cerebral Palsy Hemiplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sham tDCS

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

Group Type SHAM_COMPARATOR

Upper Extremity Robotics, tDCS

Intervention Type BEHAVIORAL

Participant will receive 20 minutes of non-invasive brain stimulation followed by one hour of shoulder/wrist robotic training.

Active tDCS

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

Group Type ACTIVE_COMPARATOR

Upper Extremity Robotics, tDCS

Intervention Type BEHAVIORAL

Participant will receive 20 minutes of non-invasive brain stimulation followed by one hour of shoulder/wrist robotic training.

Interventions

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Upper Extremity Robotics, tDCS

Participant will receive 20 minutes of non-invasive brain stimulation followed by one hour of shoulder/wrist robotic training.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Burke Medical Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Kathleen Friel

Director, Clinical Laboratory for Early Brain Injury Recovery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Burke Medical Research Institute

White Plains, New York, United States

Site Status

Countries

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United States

References

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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. doi: 10.3233/NRE-171455.

Reference Type RESULT
PMID: 28505986 (View on PubMed)

Other Identifiers

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BRC 467

Identifier Type: -

Identifier Source: org_study_id

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