Improving SCI Rehabilitation Interventions by Retraining the Brain

NeuroTherapia, Inc.

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cervical Spinal Cord Injruy

Treatments: Device: Sham tDCS + task oriented practice; Device: Active tDCS + task oriented practice

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03892746

CDMRP-SC170311 (Other Grant/Funding Number)

18-972

Details and patient eligibility

About

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

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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47 participants in 2 patient groups

Active tDCS + task oriented practice

Active Comparator group

Treatment:

Device: Active tDCS + task oriented practice

Sham tDCS + task oriented practice

Sham Comparator group

Treatment:

Device: Sham tDCS + task oriented practice