Spinal Cord InjuriesNCT03439319
Restoration of Reaching and Grasping Function in Individuals With Spinal Cord Injury Using MyndMove® Neuromodulation Therapy
A study testing MyndMove® and Conventional Therapy in people with Spinal Cord Injuries and Trauma, Nervous System, run by MyndTec Inc. at 4 sites in 2 countries.
Trial summary
A two-arm, parallel group, multicentre, single-blind, randomized controlled trial comparing electrical neuromodulation delivered by MyndMove® therapy to intensive upper-limb conventional therapy in the treatment of patients with moderate to severe motor impairment to their arms and hands from an incomplete, traumatic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Trauma, Nervous System
- What is being tested?
- MyndMove® and Conventional Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 3 Jun 2019to 31 Mar 2022
- 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 spinal cord injury
- Paralysis or paresis in both upper extremities
- At least 4 months (120 days) and less than 96 months (2,920 days) post traumatic SCI
- Baseline SCIM-SC ≤ 10
- From an inpatient or outpatient care setting
- Able to understand and follow instructions
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- Able to tolerate being in a seated position for a least one hour required to deliver upper limb therapy
- Willing to attend treatment sessions and all assessment sessions
- Able to understand and provide informed consent
- Male and female participants ≥ 18 years of age at the time of enrollment
Who cannot join
- Previous history of any other neuromuscular 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
- Rash or open wound at any potential electrode site
- History of seizure disorder not effectively managed by seizure medications
- An implanted metallic part (e.g. plates, screws or joint replacement) or electrical device (e.g. Implantable Cardiac Defibrillator, Pacemaker, Spinal Stimulation). (Note: If the participant has passive metallic implants, the therapy can be delivered if the implants are located in an area other than where the electrical stimulant is to be delivered.)
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- Complete denervation of muscles that are targeted by MyndMove such that MyndMove is unable to elicit tetanic muscle contraction when upper limits of stimulation intensity for the targeted muscle are applied
- Poorly controlled autonomic dysreflexia (as determined by the local site physician)
- History of psychiatric illness requiring hospitalization within the past 24 months
- Active drug treatment for dementia
- Life expectancy of less than 12 months due to other illness
- In the judgment of the medical provider, the participant has medical complications that may interfere with the execution of the study
- Currently enrolled in another upper limb study and/ or has received MyndMove Therapy within the past 3 months
- Enrolled, in the past six months, in a clinical study involving drugs or biologics
- Currently dependent on a ventilator
- Botulinum toxin injection into affected upper extremity and the muscle targeted by MyndMove® therapy within 6 months prior to the study start. No botulinum toxin injections in the upper extremity during the study treatment and follow up period
- Females who are pregnant or planning to become pregnant in the duration of the trial
- Regional disorder of the upper extremities such as fracture, dislocation, or joint contractures to less than 50% of the expected range of motion
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
MetroHealth Medical Center / Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, 44109
TIRR Memorial Hermann
Houston, Texas, 77030
Canada2 sites
HealthTech Connex Centre for Neurology Studies / NeuroMotion Physiotherapy Clinics ( Surrey, Vancouver and Victoria)
Surrey, British Columbia, V3V 0C6
Toronto Rehabilitation Institute
Toronto, Ontario
About this study
A two-arm, parallel group, multicentre, single-blind, randomized controlled trial comparing electrical neuromodulation delivered by MyndMove® therapy to intensive upper-limb conventional therapy in the treatment of patients with moderate to severe motor impairment to their arms and hands from an incomplete, traumatic spinal cord injury.
- Conditions
- Spinal Cord Injuries, Trauma, Nervous System
- Being tested
- MyndMove®, Conventional Therapy
- Keywords
- MyndMove, Electrical neuromodulation, conventional therapy
- Medical subject headings
- Spinal Cord Injuries, Trauma, Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyndMove®Device
This FES therapy can be used as a short-term therapeutic intervention to help improve voluntary grasping function
Conventional TherapyOther
Conventional training involves repetitive practice of upper extremity movements with manual assistance provided by a therapist as needed.
| Study group | Role | What they receive |
|---|---|---|
| MyndMove® therapy | Active comparator | Non-invasive Functional Electrical Stimulation (FES) technique with surface electrodes to stimulate from 3 to 8 muscles to create purposeful movements in one or both hands/arms Receives: Device: MyndMove® |
| Intensive Conventional therapy | Active comparator | Using Conventional therapy which focuses exclusively on the purposeful movements in one or both hands/arms Receives: Other: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy of MyndMove® therapy vs intensive conventional therapy in improving upper extremity function as measured by Spinal Cord Independence Measure self-care sub score (SCIM-SC)
SCIM-SC is a disability scale that has been specifically developed to evaluate the functional outcomes of patients with traumatic and non-traumatic SCI. The SCIM-SC assesses function of self-care, which includes feeding, bathing, dressing and grooming.
Measured: Change from baseline to 6weeks to 14 weeks to 24weeks
Secondary outcomes (4)
Change in participant's upper limb and hand impairment and function using Graded Refined Assessment of Strength Sensibility and Prehension (GRASSP)
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 6weeks to 14weeks to 24weeks
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.
that have been used to assess hand and upper limb function in the peripheral hand population
Measured: Change from baseline to 14 weeks to 24weeks
To assess safety as measured by serious and non serious adverse events (SAEs) recorded for participants in both groups of the study population over the duration of the study
Measured: Duration of the trial from baseline to 24weeks
Change in quality of life as measured by the Spinal Cord Injury-Quality of Life (SCI-QOL)
The SCI-QOL measurement system is a multifaceted system of measuring patient reported outcomes across a wide variety of functioning specifically targeted for individuals with SCI
Measured: Change from baseline to 6weeks to 14weeks to 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start3 Jun 2019
- Primary completion28 Feb 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-arm, parallel group, multicentre, single-blind, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- MyndTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research Acquisition Activity, United States Department of Defense, Programs for Assessment of Technology in Health Research Institute, McMaster University
- Responsible party
- Sponsor
- Investigators
- Steve Plymale, Study director, MyndTec Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439319
- Sponsor's protocol ID
- MM-SCI-4002
- Other IDs
- CDMRP-SC150251
- Status last verified
- Jul 2022
- First submitted
- 13 Feb 2018
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Anderson KD, Korupolu R, Musselman KE, Pierce J, Wilson JR, Yozbatiran N, Desai N, Popovic MR, Thabane L. Multi-center, single-blind randomized controlled trial comparing functional electrical stimulation therapy to conventional therapy in incomplete tetraplegia. Front Rehabil Sci. 2022 Sep 9;3:995244. doi: 10.3389/fresc.2022.995244. eCollection 2022.
PubMed 36188946Anderson KD, Wilson JR, Korupolu R, Pierce J, Bowen JM, O'Reilly D, Kapadia N, Popovic MR, Thabane L, Musselman KE. Multicentre, single-blind randomised controlled trial comparing MyndMove neuromodulation therapy with conventional therapy in traumatic spinal cord injury: a protocol study. BMJ Open. 2020 Sep 28;10(9):e039650. doi: 10.1136/bmjopen-2020-039650.
PubMed 32988951
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Reaching and Grasping Function in Individuals With Spinal Cord Injury Using MyndMove® Neuromodulation Therapy
- ClinicalTrials.gov ID
- NCT03439319
- Acronym / sponsor ID
- MM-SCI-4002
- Conditions
- Spinal Cord Injuries, Trauma, Nervous System
- Keywords
- MyndMove, Electrical neuromodulation, conventional therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- MyndTec Inc.Industry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research Acquisition Activity, United States Department of Defense, Programs for Assessment of Technology in Health Research Institute, McMaster University
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 20 Feb 2018 (actual)
- 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.
A two-arm, parallel group, multicentre, single-blind, randomized controlled trial comparing electrical neuromodulation delivered by MyndMove® therapy to intensive upper-limb conventional therapy in the treatment of patients with moderate to severe motor impairment to their arms and hands from an incomplete, traumatic spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A two-arm, parallel group, multicentre, single-blind, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| MyndMove® therapy | Active comparator | Device: MyndMove®Non-invasive Functional Electrical Stimulation (FES) technique with surface electrodes to stimulate from 3 to 8 muscles to create purposeful movements in one or both hands/arms |
| Intensive Conventional therapy | Active comparator | Other: Conventional TherapyUsing Conventional therapy which focuses exclusively on the purposeful movements in one or both hands/arms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Traumatic incomplete (AIS B-D) C4-C7 spinal cord injury
- Paralysis or paresis in both upper extremities
- At least 4 months (120 days) and less than 96 months (2,920 days) post traumatic SCI
- Baseline SCIM-SC ≤ 10
- From an inpatient or outpatient care setting
Key exclusion criteria (18 listed)
- Previous history of any other neuromuscular 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
- Rash or open wound at any potential electrode site
- History of seizure disorder not effectively managed by seizure medications
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 |
|---|---|---|
| MyndMove®This FES therapy can be used as a short-term therapeutic intervention to help improve voluntary grasping function | Device | MyndMove® therapy |
| Conventional TherapyConventional training involves repetitive practice of upper extremity movements with manual assistance provided by a therapist as needed. | Other | Intensive Conventional therapy |
Primary outcome
To compare the efficacy of MyndMove® therapy vs intensive conventional therapy in improving upper extremity function as measured by Spinal Cord Independence Measure self-care sub score (SCIM-SC)
Time frame: Change from baseline to 6weeks to 14 weeks to 24weeks
SCIM-SC is a disability scale that has been specifically developed to evaluate the functional outcomes of patients with traumatic and non-traumatic SCI. The SCIM-SC assesses function of self-care, which includes feeding, bathing, dressing and grooming.
4 secondary outcomes
Change in participant's upper limb and hand impairment and function using Graded Refined Assessment of Strength Sensibility and Prehension (GRASSP)
Time frame: Change from baseline to 6weeks to 14weeks to 24weeks
Change in participant's reaching and grasping function with the Toronto Rehab Institute Hand Function Test (TRI-HFT)
Time frame: Change from baseline to 14 weeks to 24weeks
To assess safety as measured by serious and non serious adverse events (SAEs) recorded for participants in both groups of the study population over the duration of the study
Time frame: Duration of the trial from baseline to 24weeks
Change in quality of life as measured by the Spinal Cord Injury-Quality of Life (SCI-QOL)
Time frame: Change from baseline to 6weeks to 14weeks to 24weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Derived from this study: PubMed 36188946Anderson KD, Korupolu R, Musselman KE, Pierce J, Wilson JR, Yozbatiran N, Desai N, Popovic MR, Thabane L. Multi-center, single-blind randomized controlled trial comparing functional electrical stimulation therapy to conventional therapy in incomplete tetraplegia. Front Rehabil Sci. 2022 Sep 9;3:995244. doi: 10.3389/fresc.2022.995244. eCollection 2022.
- Derived from this study: PubMed 32988951Anderson KD, Wilson JR, Korupolu R, Pierce J, Bowen JM, O'Reilly D, Kapadia N, Popovic MR, Thabane L, Musselman KE. Multicentre, single-blind randomised controlled trial comparing MyndMove neuromodulation therapy with conventional therapy in traumatic spinal cord injury: a protocol study. BMJ Open. 2020 Sep 28;10(9):e039650. doi: 10.1136/bmjopen-2020-039650.
- Individual participant dataSharing planned: No
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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.
Steve Plymale study director
MyndTec Inc.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyndMove® and Conventional Therapy in people with Spinal Cord Injuries and Trauma, Nervous System, run by MyndTec Inc. at 4 sites in 2 countries.
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 10 inclusion and 18 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: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare the efficacy of MyndMove® therapy vs intensive conventional therapy in improving upper extremity function as measured by Spinal Cord Independence Measure self-care sub score (SCIM-SC) (time frame: Change from baseline to 6weeks to 14 weeks to 24weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03439319, which also lists 2 linked publications.
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 18 Jul 2022.