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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 96 months (2,920 days) post traumatic SCI 4. Baseline SCIM-SC ≤ 10 5. From an inpatient or 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. Male and female participants ≥ 18 years of age at the time of enrollment

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 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.) 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. History of psychiatric illness requiring hospitalization within the past 24 months 10. Active drug treatment for dementia 11. Life expectancy of less than 12 months due to other illness 12. In the judgment of the medical provider, the participant has medical complications that may interfere with the execution of the study 13. Currently enrolled in another upper limb study and/ or has received MyndMove Therapy within the past 3 months 14. Enrolled, in the past six months, in a clinical study involving drugs or biologics 15. Currently dependent on a ventilator 16. 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 17. Females who are pregnant or planning to become pregnant in the duration of the trial 18. Regional disorder of the upper extremities such as fracture, dislocation, or joint contractures to less than 50% of the expected range of motion

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
A two-arm, parallel group, multicentre, single-blind, randomized controlled trial
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
MyndMove® therapy 		Non-invasive Functional Electrical Stimulation (FES) technique with surface electrodes to stimulate from 3 to 8 muscles to create purposeful movements in one or both hands/arms
  • Device: MyndMove®
    This FES therapy can be used as a short-term therapeutic intervention to help improve voluntary grasping function
Active Comparator
Intensive Conventional therapy 		Using Conventional therapy which focuses exclusively on the purposeful movements in one or both hands/arms
  • Other: Conventional Therapy
    Conventional training involves repetitive practice of upper extremity movements with manual assistance provided by a therapist as needed.

More Details

Status
Completed
Sponsor
MyndTec Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.