Clinical trial NCT02266836: MyndMove Therapy for Severe Hemiparesis of the Upper Limb Following Stroke
Official title: Clinical Feasibility and Usability of MyndMove Therapy for FES Facilitated Treatment of Subacute and Chronic Severe Hemiparesis of the Upper Limb Following Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiparesis of the Upper Limb Following Stroke
Keywords: Stroke
Cerebrovascular accident
Upper Extremity
Cerebral Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Cardiovascular Diseases
Nervous System Diseases
Central Nervous System Diseases
Lead sponsor: MyndTec Inc.
Sponsor class: INDUSTRY
Collaborators: name: University Health Network, Toronto
First posted: 2014-10-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in Upper Extremity Fugl-Meyer Assessment (UE-FMA)
timeFrame: baseline to 6 weeks
Secondary outcomes:
measure: Change in Functional Independence Measure and Self-Care Functional Independence Measure for the early subacute subjects
timeFrame: Baseline - 6 weeks
measure: System Usability Scale
timeFrame: An average of 5 weeks after therapy has begun
measure: All adverse events
timeFrame: Baseline - An average of 5 weeks after therapy has begun
measure: Amplitudes to elicit muscle movement
timeFrame: Throughout study
Other outcomes:
Locations:
city: Brampton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Debbie A Hebert, MSc(Kin)
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Mark Bayley, MD
role: PRINCIPAL_INVESTIGATOR
References: