Improving SCI Rehabilitation Interventions by Retraining the Brain

Purpose

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

Condition

  • Cervical Spinal Cord Injruy

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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 - participating in ongoing upper-limb therapies

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
In this phase I/II clinical trial, an anticipated 49(up to 54) subjects will receive 15 sessions of upper limb training while receiving either active tDCS or sham tDCS to the target in the brain devoted to the weaker triceps of the weaker upper limb.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Subjects will be randomly assigned by the Cleveland Clinic biostatistician to receive either active or sham tDCS. The tDCS will be pre-programmed with codes for active and sham stimulation. The code will be given to the intervention team by the biostatistician. Investigators analyzing functional outcome data and neurophysiology data will receive coded data that conceals the identity of the subject.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Active tDCS + task oriented practice
  • 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.
Sham Comparator
Sham tDCS + task oriented practice
  • 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

Recruiting Locations

The MetroHealth System
Cleveland, Ohio 44109
Contact:
Anne Bryden, PhD
216-957-3594
anne.bryden@case.edu

More Details

Status
Recruiting
Sponsor
The Cleveland Clinic

Study Contact

Kyle J. O'Laughlin, MS
216-445-7841
olaughk@ccf.org

Detailed Description

This is a phase I/II Multi-site Clinical Trial. In this phase I/II randomized controlled study, 49(up to 54) cervical spinal patients with upper limb impairments will receive non-invasive brain stimulation tDCS (Transcranial Direct Current Stimulation) to the area in the brain controlling the weaker muscle of the weakest upper limb while receiving training for 15 sessions over several weeks up to 8 weeks. The primary outcome will be motor limb impairment, and secondary outcomes will be tests of functional ability, spinal excitability, and strength and dexterity. Safety and feasibility of pairing tDCS with rehabilitation will also be explored and include adverse effects, subject/investigator blinding, and attrition to 3 month follow-up.