Clinical trial NCT03892746: Improving SCI Rehabilitation Interventions by Retraining the Brain
Official title: Improving SCI Rehabilitation Interventions by Retraining the Brain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cervical Spinal Cord Injruy
Keywords: Cervical Spinal Cord Injury
tDCS
Transcranial Direct Current Stimulation
Upper limb
Rehabilitation
Brain Stimulation
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2019-03-27
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Upper Extremity Motor Score(UEMS) with Manual Muscle Testing
timeFrame: Baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up.
measure: Change in GRASSP
timeFrame: Baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up.
measure: Change in Canadian Occupational Performance Measure (COPM)
timeFrame: Baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up.
measure: Change in Spinal Cord Independence Measure(SCIM)
timeFrame: Baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up.
measure: Change in excitability of cortical and corticospinal physiology (TMS)
timeFrame: Baseline (0 weeks and 3 weeks) and after intervention(up to 8 weeks)
measure: Change in excitability of spinal physiology (H-reflex)
timeFrame: Baseline (0 weeks and 3 weeks) and after intervention(up to 8 weeks)
measure: Change in Capabilities of Upper Extremity Test(CUE-T)
timeFrame: Baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up.
Secondary outcomes:
Other outcomes:
measure: Safety and Feasibility
timeFrame: Through entirity of study
measure: TMS safety questionnaire
timeFrame: Through entirity of study
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
city: Cleveland
country: United States
facility: Louis B. Stokes Cleveland VA Medical Center
state: Ohio
city: Cleveland
country: United States
facility: The MetroHealth System
state: Ohio
city: Cleveland
country: United States
facility: Lerner Research Institute; Cleveland Clinid Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Ela Plow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arora T, O'Laughlin K, Potter-Baker K, Kirshblum S, Kilgore K, Forrest GF, Bryden AM, Wang X, Henzel MK, Li M, Perlic K, Richmond MA, Pundik S, Bethoux F, Frost F, Plow EB. Safety and efficacy of transcranial direct current stimulation in upper extremity rehabilitation after tetraplegia: protocol of a multicenter randomized, clinical trial. Spinal Cord. 2022 Sep;60(9):774-778. doi: 10.1038/s41393-022-00768-z. Epub 2022 Mar 5.