MyndMove Therapy for Severe Hemiparesis of the Upper Limb Following Stroke

Not Applicable

Completed

• Conditions: Hemiparesis of the Upper Limb Following Stroke
• Interventions: Device: MyndMove

• Registration Number: NCT02266836
• Lead Sponsor: MyndTec Inc.

Brief Summary

The purpose of this study is to examine the efficacy of MyndMove therapy in the early sub-acute, late sub-acute and chronic post-stroke patients. Other objectives include assessing the required doses of electrical current amplitudes, the usability of the device, and examining the overall safety.

Detailed Description

The purpose of this study is to examine the efficacy of MyndMove therapy in the early sub-acute, late sub-acute and chronic post-stroke patients. Other objectives include assessing the required doses of electrical current amplitudes, the usability of the device, and examining the overall safety.

Many individuals experience weakness or paralysis of their arms and hands following a stroke. As a result, they are often unable to grasp and reach objects voluntarily and have difficulty performing basic activities of daily living (ADLs) such as dressing, feeding, bathing and grooming. Despite extensive rehabilitation programs, many of these individuals remain dependent on others for assistance with ADLs. This unmet medical need remains the focus of a wide range of research efforts.

MyndMove is a newly developed Functional Electrical Stimulation based treatment designed to recover voluntary movement in severely paralyzed upper limbs following stroke and spinal cord injury.

This study will enroll stroke patients that have severe hemiparesis of an upper limb (as defined by 1) an UE-FMA score of less than or equal to 19 and 2) a Chedoke McMaster Stage of 1-2 for the arm and hand). Three cohorts of patients enrolled in the study will include:

* Early sub-acute stroke patients (less than 2 months post stroke) receiving therapy during inpatient rehabilitation;

* Late sub-acute stroke patients (post-discharge from inpatient rehab and less than 6 months post stroke) receiving therapy in outpatient clinic settings; and

* Chronic stroke patients (greater than 6 months post stroke) receiving therapy in outpatient clinic settings

Study Timeline

• Study First Submitted: 2014-09-26
• Study Start: 2014-10
• Study First Submitted QC: 2014-10-14
• Study First Posted: 2014-10-17
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2019-08
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Ischemic or hemorrhagic stroke confirmed by MRI or CT scan
2. Sub-acute subjects at least 10 days post stroke. Chronic subjects at least 6 months post stroke
3. Chedoke-McMaster Stroke Assessment Stage 1-2 (arm and hand)
4. Severe hemiplegia of the upper extremity defined as UE-FMA score of less than or equal to 19
5. Subject is able to follow instructions
6. Subject is able to sit and participate in one hour of upper limb therapy
7. Anticipated to be discharged home or already at home following conventional inpatient rehabilitation
8. Willing to attend outpatient therapy if chronic or late sub-acute
9. Subject is able and willing to give written informed consent
10. Men and women aged 18 or older

Exclusion Criteria

1. Global Aphasia
2. Previous history of clinical stroke either ischemic infarct, hemorrhagic and subarachnoid bleeding
3. Upper extremity injury or condition prior to stroke that limits the function of the hand or arm
4. Life expectancy of less than 12 months due to other illness
5. Subject has malignant skin lesion on the affected upper extremity
6. Subject has history of seizure disorder and on seizure medications
7. Subject has existing electrical stimulation devices (ICD, Pacemaker, Spinal Stimulation)
8. Neurologic condition that may affect motor response (e.g. Parkinson's, ALS, MS)
9. Subject has rash or open wound at any potential electrode site
10. In the judgment of the medical provider, subject has medical complications that may interfere with the execution of the study
11. Botulinum toxin (Botox) injection into affected upper extremity at least 3 months before the study or during the study
12. Currently enrolled in another upper limb study
13. Enrolled in the past six months in a clinical study involving drugs or biologics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MyndMove	MyndMove	The MyndMove system is a neuromodulation device that delivers short electrical pulses to stimulate muscle contractions and enhance motor recovery following Stroke or Spinal Cord Injury. MyndMove delivers therapeutic stimulation sequences called protocols, which are coded therapeutic algorithms which assist muscle movement allowing the brain and central nervous system to be retrained restoring voluntary reaching and grasping functions lost following neurological injury. The MyndMove system comprises the hardware device, stimulation electrodes and cables, hand and foot switches, and integrated software.

Primary Outcome Measures

Name	Time	Method
Change in Upper Extremity Fugl-Meyer Assessment (UE-FMA)	baseline to 6 weeks	The Upper Extremity Fugl-Meyer Assessment (UE-FMA) is a standardized scale used for the evaluation of physical performance in the post-stroke hemiplegic patient. The upper extremity (UE) evaluates the function of the upper extremity motor function in four components: Shoulder/Elbow and Forearm, Wrist, Hand and Coordination and Speed in a series of performed tasks. The maximum score associated with the UE-FMA is 66 points. Each of the 33 specific tasks is scored as either 0 or an absence of function to a maximum score of 2 for the tasks being fully completed. Partial function can be scored as 1 for selected tasks. This evaluation will be completed by a trained physiotherapist or occupational therapist. Upper extremity assessment for stroke patients. Clinically Significant change is \>6 points

Secondary Outcome Measures

Name	Time	Method
Change in Functional Independence Measure and Self-Care Functional Independence Measure for the early subacute subjects	Baseline - 6 weeks	To measure the degree of disability the Functional Independence Measure will be completed. The FIM consists of 18 items of which 13 are motor related tasks and 5 are cognitive related items. The measure is broken down into 6 classifications of self-care, sphincter control, mobility, locomotion, communication and social cognition. The self-care consists of 6 items: eating, grooming, bathing, dressing-upper body, dressing-lower body, toileting. Each item is rated using a 7-point scale indicating the level of functioning from total assistance with a score of 1 to complete independence with a score of 7.
System Usability Scale	An average of 5 weeks after therapy has begun	Each Therapist will complete the System Usability Scale on the last treatment visit which is expected to be an average of 5 weeks after therapy has begun. Each question in the System Usability Scale is scored from 1 - Strongly Disagree, through to 5 - Strongly Agree. System Usability Scale scores, based on therapist assessments, at end of study compared to baseline (after basic training).
All adverse events	Baseline - An average of 5 weeks after therapy has begun	At each study visit, participants will be asked if they have experienced any adverse events. Participants will be in the study for an expected average of 5 weeks.
Amplitudes to elicit muscle movement	Throughout study	The amplitudes that are used to elicit the muscle movement will be recorded for the various muscles for each participant. The average required amplitude will be calculated and the minimum and maximum amplitudes will be noted. This will provide future guidance on the typical range of amplitudes needed for the various muscles to treat patients.