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Improving SCI Rehabilitation Interventions by Retraining the Brain

NCT03892746 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2025-12-10

Study results available
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Summary

The Long-term goal of this project is to develop upper limb rehabilitation interventions that can be utilized for cervical Spinal Cord Injury survivors.

This Study will utilize a novel method of non-invasive brain stimulation in conjunction with upper limb training given for 15 sessions over several weeks up to 8 weeks.

The Study will include the following site visits:

* Eligibility Screening and Informed Consent Visit.
* Four testing visit in which motor function of the upper limb and neurophysiology will be measured
* Fifteen intervention visits during which patients will receive upper limb training in conjunction with non-invasive brain stimulation
* Repeat testing of motor function and neurophysiology of the upper limb following completion of intervention visits
* a Follow-up visit completed 3 months after the completion of interventions

Conditions

  • Cervical Spinal Cord Injruy

Interventions

DEVICE

Active tDCS + task oriented practice

Participants in this arm will receive active tDCS (2mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.

DEVICE

Sham tDCS + task oriented practice

Participants in this arm will receive sham tDCS (0mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.

Sponsors & Collaborators

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • United States Department of Defense

    collaborator FED

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Ela Plow, PhD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-12
Primary Completion
2024-09-29
Completion
2024-10-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03892746 on ClinicalTrials.gov