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

Primary Purpose

Spinal Cord Injuries, Trauma, Nervous System

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

MyndMove®

Conventional Therapy

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring MyndMove, Electrical neuromodulation, conventional therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

MetroHealth Medical Center / Louis Stokes Cleveland VA Medical Center
TIRR Memorial Hermann
HealthTech Connex Centre for Neurology Studies / NeuroMotion Physiotherapy Clinics ( Surrey, Vancouver and Victoria)
Toronto Rehabilitation Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

MyndMove® therapy

Intensive Conventional therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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

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

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

Full Information

NCT ID

NCT03439319

First Posted

February 13, 2018

Last Updated

July 15, 2022

Sponsor

MyndTec Inc.

Collaborators

U.S. Army Medical Research Acquisition Activity, United States Department of Defense, Programs for Assessment of Technology in Health Research Institute, McMaster University

1. Study Identification

Unique Protocol Identification Number

NCT03439319

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

June 3, 2019 (Actual)

Primary Completion Date

February 28, 2022 (Actual)

Study Completion Date

March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MyndTec Inc.

Collaborators

U.S. Army Medical Research Acquisition Activity, United States Department of Defense, Programs for Assessment of Technology in Health Research Institute, McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries, Trauma, Nervous System

Keywords

MyndMove, Electrical neuromodulation, conventional therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MyndMove® therapy

Arm Type

Active Comparator

Arm Description

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

Arm Title

Intensive Conventional therapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

MyndMove®

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Conventional Therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

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)

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

Change in participant's reaching and grasping function with the Toronto Rehab Institute Hand Function Test (TRI-HFT)

Description

Time Frame

Change from baseline to 14 weeks to 24weeks

Title

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

Time Frame

Duration of the trial from baseline to 24weeks

Title

Change in quality of life as measured by the Spinal Cord Injury-Quality of Life (SCI-QOL)

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steve Plymale

Organizational Affiliation

MyndTec Inc.

Official's Role

Study Director

Facility Information:

Facility Name

MetroHealth Medical Center / Louis Stokes Cleveland VA Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44109

Country

United States

Facility Name

TIRR Memorial Hermann

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

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

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3V 0C6

Country

Canada

Facility Name

Toronto Rehabilitation Institute

City

Toronto

State/Province

Ontario

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36188946

Citation

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.

Results Reference

derived

PubMed Identifier

32988951

Citation

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.

Results Reference

derived

Learn more about this trial

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

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