CClinicalTrials.gg
Sign In
Status unknownNCT03038269Updated Oct 4, 2022

tDCS and Robotic Training in Adults With Cerebral Palsy

An interventional study of Upper Extremity Robotics, tDCS in Cerebral Palsy and Hemiplegia, sponsored by Burke Medical Research Institute. Status unknown at 1 site in United States. Open to participants aged 15 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-10-04.

Sponsored by Burke Medical Research Institute · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
15 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed 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).

02

Conditions studied

  • Cerebral Palsy
  • Hemiplegia

Keywords

  • Robotics
  • Upper Extremity
03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's planned enrollment of 22 is below the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Burke Medical Research Institute is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
22 participants (estimated)

Study arms

  • Sham comparator
    Sham tDCS

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

    Behavioral: Upper Extremity Robotics, tDCS

  • Active comparator
    Active tDCS

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

    Behavioral: Upper Extremity Robotics, tDCS

Interventions

  • BehavioralUpper Extremity Robotics, tDCS

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

06

What researchers measure

Primary outcomes

  1. Fugl-Meyer Assessment of Motor Recovery

    Evaluates and measures recovery

    Time frame: 1 Week

Secondary outcomes

  1. Wolf Motor Function Test

    Quantifies upper extremity motor ability through timed and functional tasks

    Time frame: 1 Week

  2. Box and Blocks Test

    Measures unilateral gross motor dexterity.

    Time frame: 1 Week

07

Study locations

1 site
  • Burke Medical Research Institute
    White Plains, New York 10605, United States
08

References and documents

Publications

  • 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. PubMed 28505986 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03038269
Lead sponsor
Burke Medical Research Institute
Responsible party
Kathleen Friel (Director, Clinical Laboratory for Early Brain Injury Recovery, Burke Medical Research Institute) — Principal investigator
First posted
Jan 31, 2017
Start date
Dec 2013
Primary completion
Dec 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Oct 4, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cerebral Palsy→

Other studies from this sponsor

Burke Medical Research Institute

Start the discussion