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

• ClinicalTrials.gov Identifier: NCT03439319
• Recruitment Status: Recruiting
• First Posted: February 20, 2018
• Last Update Posted: April 20, 2020
• 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
• Information provided by (Responsible Party): MyndTec Inc.

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.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injuries; Trauma, Nervous System	Device: MyndMove®; Other: Conventional Therapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A two-arm, parallel group, multicentre, single-blind, randomized controlled trial
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Restoration of Reaching and Grasping Function in Individuals With Spinal Cord Injury Using MyndMove® Neuromodulation Therapy
• Actual Study Start Date: June 3, 2019
• Estimated Primary Completion Date: September 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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) [ Time Frame: Change from baseline to 6weeks to 14 weeks to 24weeks ]
   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 :

1. Change in participant's upper limb and hand impairment and function using Graded Refined Assessment of Strength Sensibility and Prehension (GRASSP) [ Time Frame: Change from baseline to 6weeks to 14weeks to 24weeks ]
   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
2. Change in participant's reaching and grasping function with the Toronto Rehab Institute Hand Function Test (TRI-HFT) [ Time Frame: Change from baseline to 14 weeks to 24weeks ]

   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

3. 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 ]
4. Change in quality of life as measured by the Spinal Cord Injury-Quality of Life (SCI-QOL) [ Time Frame: Change from baseline to 6weeks to 14weeks to 24weeks ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Darshika Mistry, BSc; 905-363-0564 ext 223; darshika@myndtec.com

Locations

United States, Ohio

MetroHealth Medical Center / Louis Stokes Cleveland VA Medical Center; Recruiting

Cleveland, Ohio, United States, 44109

Contact: Kimberly 216-957-3558

Principal Investigator: Kimberly Anderson, PhD

Sub-Investigator: James Wilson, DO

United States, Texas

TIRR Memorial Hermann; Recruiting

Houston, Texas, United States, 77030

Contact: Ruta 713-799-6976

Principal Investigator: Radha Korupolu, MD

Sub-Investigator: Nuray Yozbatiran, PhD, PT

Canada, British Columbia

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

Surrey, British Columbia, Canada, V3V 0C6

Contact: Natasha 778-874-7758

Principal Investigator: Jacqueline Pierce, MD, FRCP(C)

Canada, Ontario

Toronto Rehabilitation Institute; Recruiting

Toronto, Ontario, Canada

Principal Investigator: Kristin Kristin Musselman, PT, PhD

Sponsors and Collaborators

MyndTec Inc.

U.S. Army Medical Research Acquisition Activity

United States Department of Defense

Programs for Assessment of Technology in Health Research Institute

McMaster University

Investigators

• Study Director: Steve Plymale; MyndTec Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: MyndTec Inc.
• ClinicalTrials.gov Identifier: NCT03439319
• Other Study ID Numbers: MM-SCI-4002; CDMRP-SC150251 ( Other Grant/Funding Number: Congressionally Directed Medical Research Programs(CDMRP),Spinal Cord Injury Research Program, US Dept of Defense )
• First Posted: February 20, 2018
• Last Update Posted: April 20, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by MyndTec Inc.:

MyndMove; Electrical neuromodulation; conventional therapy

Additional relevant MeSH terms:

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