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

NCT03439319 | Completed DMC FDA Device

• 2 other identifiers: MM-SCI-4002CDMRP-SC150251
• Study Type: interventional
• Target: 51
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Spinal Cord Injuries; Trauma, Nervous System

Keywords

MyndMove; Electrical neuromodulation; conventional therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in participant's upper limb and hand impairment and function using Graded Refined Assessment of Strength Sensibility and Prehension (GRASSP)

  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)

  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)

  Change from baseline to 6weeks to 14weeks to 24weeks

Study Arms (2)

MyndMove® therapy

ACTIVE COMPARATOR

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®

Intensive Conventional therapy

ACTIVE COMPARATOR

Using Conventional therapy which focuses exclusively on the purposeful movements in one or both hands/arms

Other: Conventional Therapy

Interventions

MyndMove® DEVICE

This FES therapy can be used as a short-term therapeutic intervention to help improve voluntary grasping function

MyndMove® therapy

Conventional Therapy OTHER

Conventional training involves repetitive practice of upper extremity movements with manual assistance provided by a therapist as needed.

Intensive Conventional therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• MyndTec Inc.: lead
• U.S. Army Medical Research Acquisition Activity: collaborator
• United States Department of Defense: collaborator
• Programs for Assessment of Technology in Health Research Institute: collaborator
• McMaster University: collaborator

Study Sites (4)

MetroHealth Medical Center / Louis Stokes Cleveland VA Medical Center

Cleveland, Ohio, 44109, United States

Location

TIRR Memorial Hermann

Houston, Texas, 77030, United States

Location

HealthTech Connex Centre for Neurology Studies / NeuroMotion Physiotherapy Clinics ( Surrey, Vancouver and Victoria)

Surrey, British Columbia, V3V 0C6, Canada

Location

Toronto Rehabilitation Institute

Toronto, Ontario, Canada

Location

Related Publications (2)

• 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.

  PMID: 36188946 DERIVED

• 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.

  PMID: 32988951 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Trauma, Nervous System

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries

Study Officials

• Steve Plymale

  MyndTec Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A two-arm, parallel group, multicentre, single-blind, randomized controlled trial

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 20, 2018
• Study Start: June 3, 2019
• Primary Completion: February 28, 2022
• Study Completion: March 31, 2022
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (2)