Restoration of Reaching and Grasping Function in Individuals With Spinal Cord Injury Using MyndMove® Neuromodulation Therapy
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ClinicalTrials.gov Identifier: NCT03439319 |
Recruitment Status : Unknown
Verified January 2020 by MyndTec Inc..
Recruitment status was: Recruiting
First Posted : February 20, 2018
Last Update Posted : April 20, 2020
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Condition or disease | Intervention/treatment | Phase |
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Spinal Cord Injuries Trauma, Nervous System | Device: MyndMove® Other: Conventional Therapy | Not Applicable |
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 |

Arm | Intervention/treatment |
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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
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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
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Other: Conventional Therapy
Conventional training involves repetitive practice of upper extremity movements with manual assistance provided by a therapist as needed. |
- 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.
- 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
- 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
- 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 ]
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439319
Contact: Darshika Mistry, BSc | 905-363-0564 ext 223 | darshika@myndtec.com |
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 |
Study Director: | Steve Plymale | MyndTec Inc. |
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 Key Record Dates |
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 |
MyndMove Electrical neuromodulation conventional therapy |
Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries |
Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases |