MyndMove Therapy for Severe Hemiparesis of the Upper Limb Following Stroke

NCT ID: NCT03323632

Last Updated: 2017-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2018-12-31

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

Conditions

Stroke

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MyndMove

Intervention Type: 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.

Interventions

MyndMove

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Debbie A Hebert, MSc(Kin)

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Toronto Rehab Inst, UHN

Toronto, Ontario, Canada

Countries

Canada

References

Hebert, D, Bowen, J. M., Ho, C. Antunes, I, O'Reilly, D. J. and Bayley, M. (2017) Examining a new functional electrical stimulation therapy with people with sever upper extremity hemiparesis and chronic stroke: A feasibility study. British Journal of Occupational Therapy. 0/0: 1 - 10.

Reference Type: BACKGROUND

Other Identifiers

14-7505DE

Identifier Type: OTHER

Identifier Source: secondary_id

MT ST-2001

Identifier Type: -

Identifier Source: org_study_id