Traumatic Spinal Cord InjuriesMyndMoveNCT02799966
Recovery of Upper Limb Function in Persons With Spinal Cord Injury: Lead-In Study
A study testing Myndmove in people with Traumatic Spinal Cord Injuries, run by University of British Columbia at 3 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Spinal Cord Injuries
- What is being tested?
- Myndmove
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesCanada
- Study dates
- 12 Dec 2017to 7 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Stan Cassidy Centre
Fredericton, New Brunswick
Toronto Rehabilitation Institute
Toronto, Ontario
GF Strong Rehab Centre
Vancouver, British Columbia
About this study
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.
Read the detailed description
There is no control group for this study. Participants from both treatment groups:
- Early treatment group = 10 days to 6 months post tSCI and
- Late treatment group = 6 months plus one day post tSCI will receive one session (60 minutes) of MyndMove therapy, 3 to 5 times per week (only once per day), to gain 20 hours of intervention (total treatment duration will be 4 to 7 weeks).
Each 1 hour session includes therapy for single-arm or bilateral (left and right upper extremities) as clinically indicated for each study participant. Over the course of 20 one hour sessions, participants will progress through the various movement sequences aimed at regaining natural, unassisted voluntary movement in the affected limb(s). The MyndMove therapy will be in addition to the conventional upper limb rehabilitation therapy the participant will be prescribed to undertake at their local institution.
From previous experience, the first signs of function recovery may be expected to emerge two to four weeks after the onset of the MyndMove therapy program. As soon as the participant shows signs of recovery of either the voluntary extension or flexion in a stimulated muscle group, s/he will be encouraged to make an effort to voluntarily produce the movement that was previously facilitated by FES. As the participant demonstrates improved strength and range of motion, the FES for that muscle group will be phased out, and moved to another muscle group that is still paralyzed and needs to be "reactivated". The order in which muscle groups will be sequentially "reactivated" will be patient dependent.
Muscle reactivation milestones will be monitored and recorded during MyndMove therapy. The number of MyndMove treatments required to reach each milestone will be recorded. In addition, the overall time required to reach each milestone will be recorded.
Total duration of study participation, including a follow-up assessment, will be approximately 4 to 5 months.
- Conditions
- Traumatic Spinal Cord Injuries
- Being tested
- Myndmove
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyndmoveDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Treatment Group | Other | Initiate treatment with MyndMove device on or after 10 days to 6 months (182 days) post spinal cord injury Receives: 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 Receives: Device: Myndmove |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to 4/7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start12 Dec 2017
- Primary completion7 Jul 2019
- Study completion7 Jul 2019
Why it stopped: Collaborator, MyndTec, withdrew from the study due to lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Rick Hansen Institute, MyndTec Inc.
- Responsible party
- Principal investigator, Andrea Townson, University of British Columbia
- Investigators
- Andrea Townson, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799966
- Sponsor's protocol ID
- H16-00552
- Acronym
- MyndMove
- Status last verified
- Sep 2019
- First submitted
- 25 May 2016
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery of Upper Limb Function in Persons With Spinal Cord Injury: Lead-In Study
- ClinicalTrials.gov ID
- NCT02799966
- Acronym / sponsor ID
- MyndMove / H16-00552
- Conditions
- Traumatic Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Collaborator, MyndTec, withdrew from the study due to lack of resources
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Rick Hansen Institute, MyndTec Inc.
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 7 Jul 2019 (actual)
- Study completion
- 7 Jul 2019 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There is no control group for this study. Participants from both treatment groups:
- Early treatment group = 10 days to 6 months post tSCI and
- Late treatment group = 6 months plus one day post tSCI will receive one session (60 minutes) of MyndMove therapy, 3 to 5 times per week (only once per day), to gain 20 hours of intervention (total treatment duration will be 4 to 7 weeks).
Each 1 hour session includes therapy for single-arm or bilateral (left and right upper extremities) as clinically indicated for each study participant. Over the course of 20 one hour sessions, participants will progress through the various movement sequences aimed at regaining natural, unassisted voluntary movement in the affected limb(s). The MyndMove therapy will be in addition to the conventional upper limb rehabilitation therapy the participant will be prescribed to undertake at their local institution.
From previous experience, the first signs of function recovery may be expected to emerge two to four weeks after the onset of the MyndMove therapy program. As soon as the participant shows signs of recovery of either the voluntary extension or flexion in a stimulated muscle group, s/he will be encouraged to make an effort to voluntarily produce the movement that was previously facilitated by FES. As the participant demonstrates improved strength and range of motion, the FES for that muscle group will be phased out, and moved to another muscle group that is still paralyzed and needs to be "reactivated". The order in which muscle groups will be sequentially "reactivated" will be patient dependent.
Muscle reactivation milestones will be monitored and recorded during MyndMove therapy. The number of MyndMove treatments required to reach each milestone will be recorded. In addition, the overall time required to reach each milestone will be recorded.
Total duration of study participation, including a follow-up assessment, will be approximately 4 to 5 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Treatment Group | Other | Device: MyndmoveInitiate treatment with MyndMove device on or after 10 days to 6 months (182 days) post spinal cord injury |
| Late Treatment Group | Other | Device: MyndmoveInitiate treatment with MyndMove device on or after 6 months plus one day (183 days+) post spinal cord injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myndmove20 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. | Device | Early Treatment Group, Late Treatment Group |
Primary outcome
Change in participant's ability to do regular tasks of daily living as measured by the Spinal Cord Independence Measure (SCIM) questionnaire
Time frame: Change from baseline to 4/7 weeks
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 in participant's upper limb and hand impairment and function using GRASSP (Graded Refined Assessment of Strength Sensibility Test).
Time frame: Change from baseline to 4/7 weeks
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 in participant's reaching and grasping function with the Toronto Rehab Institute Hand Function Test (TRI-HFT).
Time frame: Change from baseline to 4/7 weeks
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 in participant's grasp, grip, pinch and gross movement of the arm and upper limb using the Action Research Arm Test (ARAT).
Time frame: Change from baseline to 4/7 weeks
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.
Results and safety
The study was stopped early (reason given: Collaborator, MyndTec, withdrew from the study due to lack of resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Townson, MD principal investigator
University of British Columbia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myndmove in people with Traumatic Spinal Cord Injuries, run by University of British Columbia at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Collaborator, MyndTec, withdrew from the study due to lack of resources). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in participant's ability to do regular tasks of daily living as measured by the Spinal Cord Independence Measure (SCIM) questionnaire (time frame: Change from baseline to 4/7 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.