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

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.

Study Overview

• Status: Completed
• Conditions: Trauma, Nervous System; Spinal Cord Injuries
• Intervention / Treatment: Device: MyndMove®; Other: Conventional Therapy

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
      • HealthTech Connex Centre for Neurology Studies / NeuroMotion Physiotherapy Clinics ( Surrey, Vancouver and Victoria)
  • Ontario
    • Toronto, Ontario, Canada
      • Toronto Rehabilitation Institute
• United States
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center / Louis Stokes Cleveland VA Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • TIRR Memorial Hermann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the efficacy of MyndMove® therapy vs intensive conventional therapy in improving upper extremity function as measured by Spinal Cord Independence Measure self-care sub score (SCIM-SC)	SCIM-SC is a disability scale that has been specifically developed to evaluate the functional outcomes of patients with traumatic and non-traumatic SCI. The SCIM-SC assesses function of self-care, which includes feeding, bathing, dressing and grooming.	Change from baseline to 6weeks to 14 weeks to 24weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in participant's upper limb and hand impairment and function using Graded Refined Assessment of Strength Sensibility and Prehension (GRASSP)	This is a multi-modality test designed to assess the integration of sensorimotor hand and upper limb impairment and function. This test combines the features of several other tests that have been used to assess hand and upper limb function in the peripheral hand population	Change from baseline to 6weeks to 14weeks to 24weeks
Change in participant's reaching and grasping function with the Toronto Rehab Institute Hand Function Test (TRI-HFT)	A test developed to evaluate improvements in the gross motor function of the unilateral grasp due to FES for reaching and grasping treatment. Hand functions that will be tested with the TRI-HFT are: lateral or pulp pinch, and palmar grasps. that have been used to assess hand and upper limb function in the peripheral hand population	Change from baseline to 14 weeks to 24weeks
To assess safety as measured by serious and non serious adverse events (SAEs) recorded for participants in both groups of the study population over the duration of the study		Duration of the trial from baseline to 24weeks
Change in quality of life as measured by the Spinal Cord Injury-Quality of Life (SCI-QOL)	The SCI-QOL measurement system is a multifaceted system of measuring patient reported outcomes across a wide variety of functioning specifically targeted for individuals with SCI	Change from baseline to 6weeks to 14weeks to 24weeks

Collaborators and Investigators

• Sponsor: MyndTec Inc.
• Collaborators: United States Department of Defense; McMaster University; U.S. Army Medical Research Acquisition Activity; Programs for Assessment of Technology in Health Research Institute
• Investigators: Study Director: Steve Plymale, MyndTec Inc.

Publications and helpful links

General Publications

• Anderson KD, Korupolu R, Musselman KE, Pierce J, Wilson JR, Yozbatiran N, Desai N, Popovic MR, Thabane L. Multi-center, single-blind randomized controlled trial comparing functional electrical stimulation therapy to conventional therapy in incomplete tetraplegia. Front Rehabil Sci. 2022 Sep 9;3:995244. doi: 10.3389/fresc.2022.995244. eCollection 2022.
• Anderson KD, Wilson JR, Korupolu R, Pierce J, Bowen JM, O'Reilly D, Kapadia N, Popovic MR, Thabane L, Musselman KE. Multicentre, single-blind randomised controlled trial comparing MyndMove neuromodulation therapy with conventional therapy in traumatic spinal cord injury: a protocol study. BMJ Open. 2020 Sep 28;10(9):e039650. doi: 10.1136/bmjopen-2020-039650.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 3, 2019
• Primary Completion (ACTUAL): February 28, 2022
• Study Completion (ACTUAL): March 31, 2022

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (ACTUAL): February 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: MyndMove; Electrical neuromodulation; conventional therapy
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries; Trauma, Nervous System
• Other Study ID Numbers: MM-SCI-4002; CDMRP-SC150251 (OTHER_GRANT: Congressionally Directed Medical Research Programs(CDMRP),Spinal Cord Injury Research Program, US Dept of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes