Improving SCI Rehabilitation Interventions by Retraining the Brain

Phase 1

Completed

• Conditions: Cervical Spinal Cord Injruy
• Interventions: Device: Sham tDCS + task oriented practice; Device: Active tDCS + task oriented practice

• Registration Number: NCT03892746
• Lead Sponsor: The Cleveland Clinic

Brief 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

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.

Study Timeline

• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-27
• Study Start: 2019-07-12
• Primary Completion: 2024-09-29
• Study Completion: 2024-10-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tDCS + task oriented practice	Sham tDCS + task oriented practice	-
Active tDCS + task oriented practice	Active tDCS + task oriented practice	-

Primary Outcome Measures

Name	Time	Method
Change in Capabilities of Upper Extremity Test(CUE-T)	Baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up.	CUE-T is a functional measure which identifies the functional ability of the upper limbs and is widely used in studies recruiting Spinal Cord Injury patients
Change in Upper Extremity Motor Score(UEMS) with Manual Muscle Testing	Baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up.	UEMS is used in Spinal Cord injury to identify strength(muscle power) in patients with spinal cord injury.
Change in Canadian Occupational Performance Measure (COPM)	Baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up.	COPM is used to measure participation restrictions of Spinal Cord Injury Subjects
Change in excitability of cortical and corticospinal physiology (TMS)	Baseline (0 weeks and 3 weeks) and after intervention(up to 8 weeks)	Transcranial magnetic stimulation will be used to test cortical and corticospinal physiology. The threshold of the biceps and triceps of the weaker upper limb will be collected. Motor maps dedicated to the biceps and triceps of the weaker upper limb will be collected. These motor maps will show the area and strength of neuronal control to the biceps and triceps of the weaker upper limb.
Change in GRASSP	Baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up.	GRASSP is a functional measure which identifies the functional ability of the upper limbs and is widely used in studies recruiting Spinal Cord Injury patients
Change in Spinal Cord Independence Measure(SCIM)	Baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up.	SCIM is a spinal cord injury measure that identifies activity limitations of self-care
Change in excitability of spinal physiology (H-reflex)	Baseline (0 weeks and 3 weeks) and after intervention(up to 8 weeks)	Spinal pathways will be tested using peripheral nerve testing. During this testing H-reflex will be collected.

Trial Locations

Locations (4)

Kessler Foundation; 🇺🇸 West Orange, New Jersey, United States

Louis B. Stokes Cleveland VA Medical Center; 🇺🇸 Cleveland, Ohio, United States

The MetroHealth System; 🇺🇸 Cleveland, Ohio, United States

Lerner Research Institute; Cleveland Clinid Foundation; 🇺🇸 Cleveland, Ohio, United States