NCT03038269

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 4, 2022

Status Verified

October 1, 2022

Enrollment Period

9 years

First QC Date

January 30, 2017

Last Update Submit

October 2, 2022

Conditions

Cerebral PalsyHemiplegia

Keywords

RoboticsUpper Extremity

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Assessment of Motor Recovery

    Evaluates and measures recovery

    1 Week

Secondary Outcomes (2)

  • Wolf Motor Function Test

    1 Week

  • Box and Blocks Test

    1 Week

Study Arms (2)

Sham tDCS

SHAM COMPARATOR

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

Behavioral: Upper Extremity Robotics, tDCS

Active tDCS

ACTIVE COMPARATOR

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

Behavioral: Upper Extremity Robotics, tDCS

Interventions

Upper Extremity Robotics, tDCSBEHAVIORAL

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

Active tDCSSham tDCS

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burke Medical Research Institute

White Plains, New York, 10605, United States

Location

Related 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. doi: 10.3233/NRE-171455.

    PMID: 28505986RESULT

MeSH Terms

Conditions

Cerebral PalsyHemiplegia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Clinical Laboratory for Early Brain Injury Recovery

Study Record Dates

First Submitted

January 30, 2017

First Posted

January 31, 2017

Study Start

December 1, 2013

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

October 4, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)