Traumatic Spinal Cord Injuries Clinical Trial
— MyndMoveOfficial title:
Recovery of Upper Limb Function in Persons With Spinal Cord Injury: Lead-In Study
| Verified date | September 2019 |
| Source | University of British Columbia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 9 |
| Est. completion date | July 7, 2019 |
| Est. primary completion date | July 7, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Traumatic incomplete (AIS B-D) C4-C7 SCI 2. 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) 3. Late treatment group = initiate treatment on or after 6 months plus one day (183 days+) post tSCI 4. SCIM self-care sub-score = 10 5. Able to understand and follow instructions 6. Able to be in a seated position for a least one hour of upper limb therapy 7. Able to attend the study treatment sessions 8. Able to provide informed consent 9. Men and women of the age of majority in their province or state Exclusion Criteria: 1. Previous history of any other neurological disorder or conditions that may affect motor response 2. Upper extremity injury or condition prior to SCI that limits the function of the hand or arm 3. Malignant skin lesion on the affected upper extremity 4. History of seizure disorder not effectively managed by seizure medications 5. An existing electrical stimulation devices (e.g. ICD, Pacemaker, Spinal Stimulation) 6. Rash or open wound at any potential electrode site 7. Denervation of muscles that are targeted by MyndMove 8. Poorly controlled autonomic dysreflexia (as determined by the local site physician) 9. In the judgment of the local site physician, participant has medical complications that may interfere with the execution of the study 10. 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. 11. Currently enrolled in another upper limb study 12. Enrolled, in the past six months, in a clinical study involving drugs or biologics |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Stan Cassidy Centre | Fredericton | New Brunswick |
| Canada | Toronto Rehabilitation Institute | Toronto | Ontario |
| Canada | GF Strong Rehab Centre | Vancouver | British Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| University of British Columbia | MyndTec Inc., Rick Hansen Institute |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 |