MyndMove Therapy for Severe Hemiparesis of the Upper Limb Following Stroke

NCT02266836 | Completed

• 1 other identifier: MT-ST-2001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in Upper Extremity Fugl-Meyer Assessment (UE-FMA)

  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

  baseline to 6 weeks

Secondary Outcomes (4)

• Change in Functional Independence Measure and Self-Care Functional Independence Measure for the early subacute subjects

  Baseline - 6 weeks

• System Usability Scale

  An average of 5 weeks after therapy has begun

• All adverse events

  Baseline - An average of 5 weeks after therapy has begun

• Amplitudes to elicit muscle movement

  Throughout study

Study Arms (1)

MyndMove

EXPERIMENTAL

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.

Device: MyndMove

Interventions

MyndMove DEVICE

During a MyndMove therapy session, the patient is instructed to attempt to execute a task voluntarily. As the patient is attempting to perform the designated task, specific muscles in the arm are stimulated to generate contractions that produce the desired movement. After a brief interval of the patient attempting to initiate a movement the therapist activates the MyndMove stimulation protocol, which generates bursts of short electrical pulses, using surface electrodes, to produce muscle contractions enabling the patient to complete the desired/instructed task. Proper sequencing of the muscle contractions as per the MyndMove protocols are tailored to achieve a wide range of reaching and grasping functions. The technique stimulates non-damaged pathways of the central nervous system.

MyndMove

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• MyndTec Inc.: lead
• University Health Network, Toronto: collaborator

Study Sites (6)

Unknown Facility

Brampton, Ontario, Canada

Location

Unknown Facility

London, Ontario, Canada

Location

Unknown Facility

Oshawa, Ontario, Canada

Location

Unknown Facility

Ottawa, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Windsor, Ontario, Canada

Location

MeSH Terms

Conditions

Stroke; Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Cardiovascular Diseases; Nervous System Diseases; Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Brain Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Debbie A Hebert, MSc(Kin)

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Mark Bayley, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: October 17, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 28, 2020

Record last verified: 2019-08

Locations

CA (6)