Restoration of Reaching and Grasping Function in Individuals With Spinal Cord Injury Using MyndMove® Neuromodulation Therapy

Completed · Not applicable

Conditions studied: Spinal Cord Injuries, Trauma, Nervous System

In brief

A two-arm, parallel group, multicentre, single-blind, randomized controlled trial comparing electrical neuromodulation delivered by MyndMove® therapy to intensive upper-limb conventional therapy in the treatment of patients with moderate to severe motor impairment to their arms and hands from an incomplete, traumatic spinal cord injury.

Key facts

Study ID: NCT03439319
Run by: MyndTec Inc.
People needed: 51
Starts: 2019-06-03
Expected to finish: 2022-03-31
Last updated by the study team: 2022-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Traumatic incomplete (AIS B-D) C4-C7 spinal cord injury
Paralysis or paresis in both upper extremities
At least 4 months (120 days) and less than 96 months (2,920 days) post traumatic SCI
Baseline SCIM-SC ≤ 10
From an inpatient or outpatient care setting
Able to understand and follow instructions
Able to tolerate being in a seated position for a least one hour required to deliver upper limb therapy
Willing to attend treatment sessions and all assessment sessions
Able to understand and provide informed consent
Male and female participants ≥ 18 years of age at the time of enrollment

You may not qualify if…

Previous history of any other neuromuscular disorder or conditions that may affect motor response
Upper extremity injury or condition prior to SCI that limits the function of the hand or arm
Malignant skin lesion on the affected upper extremity
Rash or open wound at any potential electrode site
History of seizure disorder not effectively managed by seizure medications
An implanted metallic part (e.g. plates, screws or joint replacement) or electrical device (e.g. Implantable Cardiac Defibrillator, Pacemaker, Spinal Stimulation). (Note: If the participant has passive metallic implants, the therapy can be delivered if the implants are located in an area other than where the electrical stimulant is to be delivered.)
Complete denervation of muscles that are targeted by MyndMove such that MyndMove is unable to elicit tetanic muscle contraction when upper limits of stimulation intensity for the targeted muscle are applied
Poorly controlled autonomic dysreflexia (as determined by the local site physician)
History of psychiatric illness requiring hospitalization within the past 24 months
Active drug treatment for dementia
Life expectancy of less than 12 months due to other illness
In the judgment of the medical provider, the participant has medical complications that may interfere with the execution of the study
Currently enrolled in another upper limb study and/ or has received MyndMove Therapy within the past 3 months
Enrolled, in the past six months, in a clinical study involving drugs or biologics
Currently dependent on a ventilator
Botulinum toxin injection into affected upper extremity and the muscle targeted by MyndMove® therapy within 6 months prior to the study start. No botulinum toxin injections in the upper extremity during the study treatment and follow up period
Females who are pregnant or planning to become pregnant in the duration of the trial
Regional disorder of the upper extremities such as fracture, dislocation, or joint contractures to less than 50% of the expected range of motion

Where it is running

MetroHealth Medical Center / Louis Stokes Cleveland VA Medical Center — Cleveland, Ohio, United States
TIRR Memorial Hermann — Houston, Texas, United States
HealthTech Connex Centre for Neurology Studies / NeuroMotion Physiotherapy Clinics ( Surrey, Vancouver and Victoria) — Surrey, British Columbia, Canada
Toronto Rehabilitation Institute — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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