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CompletedPhase 1/2

Improving SCI Rehabilitation Interventions by Retraining the Brain

Key facts

Who runs it
The Cleveland Clinic
Where
Cleveland and West Orange, United StatesSee the 4 sites
Trial code
Status
Completed
Phase
Phase 1/2
People taking part
47 people enrolled
Started
12 Jul 2019
Ended
9 Oct 2024
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Active tDCS + task oriented practice
  • Sham tDCS + task oriented practice
Record updated
10 December 2025

Who can take part

Age
18 years to 75 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • Patients with incomplete (having sparing to muscles in the upper extremities below the level of injury) C1-C8 SCI
  • at least 1 year post injury
  • weakness of the triceps or biceps muscle in the weaker upper limb, defined as a clinically detectable difference in power compared to the power of the spared antagonist(biceps and triceps respectively) muscle, i.e., at least one muscle grade lower on the MRC scale

Who cannot take part

  • participating in ongoing upper-limb therapies
  • contraindications to tDCS and TMS including: pacemaker, metal in the skull, seizure history, pregnancy
  • pressure ulcers
  • traumatic brain injury (TBI), diagnosed based upon acute injury Rancho scale <5 or positive MRI/CT findings at the time of injury will also be excluded to prevent confounding of TMS metrics
  • excessive tone/spasticity and severe contractures or soft tissue shortening at the elbow/wrist

Where in United States

  • Lerner Research Institute; Cleveland Clinid FoundationCleveland, United StatesNo longer taking part
  • Louis B. Stokes Cleveland VA Medical CenterCleveland, United StatesNo longer taking part
  • The MetroHealth SystemCleveland, United StatesNo longer taking part
  • Kessler FoundationWest Orange, United StatesNo longer taking part

About the trial

What the trial wants to find out

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

Read full original descriptionShow less

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

The 2 groups in the trial

  • Active tDCS + task oriented practiceExisting treatment, for comparison
  • Sham tDCS + task oriented practiceSham treatment, for comparison

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
10 December 2025