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

Status:Not yet recruiting
Conditions:Hospital, Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Age Range:18 - Any
Start Date:May 2018
End Date:September 2020
Contact:Darshika Mistry, BSc

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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, sub-acute, traumatic spinal cord injury.

Inclusion Criteria:

1. Traumatic incomplete (AIS B-D) C4-C7 spinal cord injury

2. Paralysis or paresis in both upper extremities

3. At least 4 months (120 days) and less than 1 year (365 days) post traumatic SCI

4. Baseline SCIM-SC ≤ 10

5. From an outpatient care setting

6. Able to understand and follow instructions

7. Able to tolerate being in a seated position for a least one hour required to deliver
upper limb therapy

8. Willing to attend treatment sessions and all assessment sessions

9. Able to understand and provide informed consent

10. Men and women of the age of maturity in their Province or State

Exclusion Criteria:

1. Previous history of any other neuromuscular disorder or conditions that may affect
motor response

2. Upper extremity injury or condition prior to SCI that limits the function of the hand
or arm

3. Malignant skin lesion on the affected upper extremity

4. Rash or open wound at any potential electrode site

5. History of seizure disorder not effectively managed by seizure medications

6. An existing electrical stimulation devices (e.g. Implantable Cardiac Defibrillator,
Pacemaker, Spinal Stimulation)

7. 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.

8. Poorly controlled autonomic dysreflexia (as determined by the local site physician)

9. Modified Ashworth Scale (MAS) score of 4 of finger flexors, or finger extensors or
wrist flexors or wrist extensors or biceps or triceps.

10. History of psychiatric illness requiring hospitalization within past 24 months

11. Active drug treatment for dementia

12. Life expectancy of less than 12 months due to other illness

13. In the judgment of the medical provider, participant has medical complications that
may interfere with the execution of the study

14. Currently enrolled in another upper limb study

15. Enrolled, in the past six months, in a clinical study involving drugs or biologics
We found this trial at
Houston, Texas 77030
Principal Investigator: Argyrios Stampas, MD
Houston, TX
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261 Mack Avenue
Detroit, Michigan 48201
Principal Investigator: Lawrence Horn, M.D. MRM
Detroit, MI
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4255 Laurel Street
Vancouver, British Columbia V5Z 2G9
Principal Investigator: Andrea Townson, FRCPC, MScHPEd
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