Recovery of Upper Limb Function in Persons With Spinal Cord Injury: Lead-In Study

NCT02799966 | Terminated DMC

• 1 other identifier: H16-00552
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief Summary

Many individuals with cervical spinal cord injury (SCI) have difficulty using their hands and arms. MyndMove is a non-invasive medical device that uses short, low energy electrical pulses with surface electrodes to cause muscle contractions to produce a full range of reaching and grasping movements, which the patient is unable to perform by him/herself. By using MyndMove therapy to help the individual move their arms and hands as he/she attempts to carry out typical reaching and grasping movements, the individual improves their ability to perform these tasks voluntarily. The purpose of this study is to study the effectiveness of MyndMove therapy in improving the ability of individuals to move their arms and hands.

Conditions

Traumatic Spinal Cord Injuries

Outcome Measures

Primary Outcomes (4)

• Change in participant's ability to do regular tasks of daily living as measured by the Spinal Cord Independence Measure (SCIM) questionnaire

  This is a disability scale that has been specifically developed to evaluate the functional outcomes of patients with traumatic and non-traumatic SCI. The SCIM assesses function in three core areas: 1) Self-care, which includes feeding, bathing, dressing and grooming; 2) Respiration and sphincter management; and lastly 3) Mobility.

  Change from baseline to 4/7 weeks

• Change in participant's upper limb and hand impairment and function using GRASSP (Graded Refined Assessment of Strength Sensibility Test).

  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 from baseline to 4/7 weeks

• Change in participant's reaching and grasping function with the Toronto Rehab Institute Hand Function Test (TRI-HFT).

  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.

  Change from baseline to 4/7 weeks

• Change in participant's grasp, grip, pinch and gross movement of the arm and upper limb using the Action Research Arm Test (ARAT).

  A test developed to assess the upper limb function in stroke and SCI patients. It consists of four sub-tests: grasp, grip, pinch and gross movement.

  Change from baseline to 4/7 weeks

Study Arms (2)

Early Treatment Group

OTHER

Initiate treatment with MyndMove device on or after 10 days to 6 months (182 days) post spinal cord injury

Device: Myndmove

Late Treatment Group

OTHER

Initiate treatment with MyndMove device on or after 6 months plus one day (183 days+) post spinal cord injury

Device: Myndmove

Interventions

Myndmove DEVICE

20 sessions of 1 hour treatments with the MyndMove device (functional electrical stimulation) to the muscles of the upper limb(s), conducted 3 to 5 times per week, over 4 to 7 weeks.

Early Treatment Group; Late Treatment Group

Eligibility Criteria

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

You may qualify if:

• Traumatic incomplete (AIS B-D) C4-C7 SCI
• Early treatment group = 10 days to 6 months (182 days) post tSCI (note it is expected that most ppts will be recruited from this group, while at GF Strong)
• Late treatment group = initiate treatment on or after 6 months plus one day (183 days+) post tSCI
• SCIM self-care sub-score ≤ 10
• Able to understand and follow instructions
• Able to be in a seated position for a least one hour of upper limb therapy
• Able to attend the study treatment sessions
• Able to provide informed consent
• Men and women of the age of majority in their province or state

You may not qualify if:

• Previous history of any other neurological 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
• History of seizure disorder not effectively managed by seizure medications
• An existing electrical stimulation devices (e.g. ICD, Pacemaker, Spinal Stimulation)
• Rash or open wound at any potential electrode site
• Denervation of muscles that are targeted by MyndMove
• Poorly controlled autonomic dysreflexia (as determined by the local site physician)
• In the judgment of the local site physician, participant has medical complications that may interfere with the execution of the study
• Botulinum toxin injection into affected upper extremity within 3 months prior to the study start. No botulinum toxin injections during the study treatment and follow up period.
• Currently enrolled in another upper limb study
• Enrolled, in the past six months, in a clinical study involving drugs or biologics

Sponsors & Collaborators

• University of British Columbia: lead
• Rick Hansen Institute: collaborator
• MyndTec Inc.: collaborator

Study Sites (3)

GF Strong Rehab Centre

Vancouver, British Columbia, Canada

Location

Stan Cassidy Centre

Fredericton, New Brunswick, Canada

Location

Toronto Rehabilitation Institute

Toronto, Ontario, Canada

Location

Study Officials

• Andrea Townson, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 15, 2016
• Study Start: December 12, 2017
• Primary Completion: July 7, 2019
• Study Completion: July 7, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

CA (3)