Improving SCI Rehabilitation Interventions by Retraining the Brain

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-12

Study Completion Date

2024-10-09

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Cervical Spinal Cord Injruy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Active tDCS + task oriented practice

Group Type ACTIVE_COMPARATOR

Active tDCS + task oriented practice

Intervention Type DEVICE

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 tDCS + task oriented practice

Group Type SHAM_COMPARATOR

Sham tDCS + task oriented practice

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes