Spinal Cord Injury CervicalNCT06494020
Task Practice and Spinal Cord Stimulation
A study testing Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS) in people with Spinal Cord Injury Cervical and Spastic, run by University of Miami at 2 sites in United States.
Trial summary
The goal of this study is to understand the effects of combined task practice with transcutaneous cervical spinal cord stimulation. The study will explore the effect of higher stimulation frequencies on spasticity. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Spinal Cord Injury Cervical, Spastic
- What is being tested?
- Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2024to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 22-70 years of age
- Non-progressive cervical spinal cord injury
- Minimum 12 months year post-injury.
- American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D.
- Able to take part in upper extremity therapy procedures.
- GRASSP-Prehension score ≥10.
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- MAS Score ≥3 but <6 in at least one arm.
- Can commit to the time required for the study.
- Stable medication profile for at least 4 weeks prior to enrollment.
- Able to reduce Baclofen dose to 30 mg or less daily.
- Capable of providing informed consent.
Who cannot join
- Has any unstable or significant medical condition that is likely to interfere with study procedures like severe neuropathic pain, depression, mood disorders, or other cognitive disorders.
- Has uncontrolled cardiopulmonary disease or cardiac symptoms.
- Requires ventilator support.
- Has been diagnosed with autonomic dysreflexia that is severe, unstable, and uncontrolled.
- Has an autoimmune etiology of spinal cord dysfunction/injury
- Previously diagnosed as having transverse myelitis
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- History of additional neurologic diseases such as stroke, multiple sclerosis, traumatic brain injury, epilepsy or history of seizures.
- Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
- Uncontrolled spasms, which have been unstable over the past three months prior to enrollment and are not expected to change.
- Received Botulinum toxin injections in their upper extremity, neck, or hand within six months prior to enrollment.
- Has painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection at the time of enrollment.
- Breakdown in skin area that will come into contact with electrodes.
- Presence of syringomyelia as determined by an MRI.
- Currently undergoing treatment for cancer or has been in remission for less than 2 years.
- Received stem cell treatment within the past two years prior to enrollment.
- Has any active implanted medical device.
- Concurrent participation in another drug or device trial that may interfere with this study.
- In the opinion of the investigators, the study is not safe or appropriate for the participant.
- Persons who are unable to consent, pregnant women, and prisoners.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami - Christine E. Lynn Rehabilitation Center
Miami, Florida, 33136
University of Miami, Miller School of Medicine, The Miami Project To Cure Paralysis
Miami, Florida, 33136
About this study
Official title: Task Practice Combined With Transcutaneous Spinal Cord Stimulation to Reduce Muscle Co-contraction and Improve Motor Function in Chronic Spinal Cord Injury
The goal of this study is to understand the effects of combined task practice with transcutaneous cervical spinal cord stimulation. The study will explore the effect of higher stimulation frequencies on spasticity. Transcutaneous stimulation has been shown to improve motor function in some individuals with chronic spinal cord injury. The study intends to explore scientifically the association between higher stimulation frequencies and spasticity/hypertonicity.
- Conditions
- Spinal Cord Injury Cervical, Spastic
- Being tested
- Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS)
- Keywords
- Transcutaneous, Transcutaneous Cervical Spinal Cord Stimulation
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS)Other
Hand rehabilitative tasks ( for gross hand movement, grasp and pinch tasks) will be done by participants during which time the participant will receive TcSCS. This will be done three times a week for 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Task Practice with stimulation | Experimental | Participants in this group will receive combined Transcutaneous cervical spinal cord stimulation with task practice for up to 2 months. Receives: Other: Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motor performance as measured by The Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP) test
GRASSP is a multimodal test that measures sensorimotor and prehension function in three domains that are important for the description of arm and hand functions, namely strength, sensation and prehension strength. It is an ordinal scale (minimum value = 0, maximum value = 100) with higher scores indicating better performance.
There is a sensation category ordinal scale (minimum value = 0 maximum value = 24) that measures sensation where higher scores indicate greater sensation.
The Prehension performance category has an ordinal scale (minimum value = 0 maximum value = 40) that measures prehension where higher scores indicate greater ability.
Measured: baseline, up to 4 months
Secondary outcomes (1)
Change in Spasticity as measured by Modified Ashworth Scale (MAS)
6 category ordinal scale (minimum value = 0 maximum value = 4) that measures spasticity where higher scores indicate greater spasticity.
Measured: baseline, up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Sep 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury CervicalStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- ONWARD Medical, Inc., United States Department of Defense
- Responsible party
- Principal investigator, James D. Guest, University of Miami
- Investigators
- James Guest, MD, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494020
- Sponsor's protocol ID
- 20230228
- Status last verified
- Aug 2026
- First submitted
- 2 Jul 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task Practice Combined With Transcutaneous Spinal Cord Stimulation to Reduce Muscle Co-contraction and Improve Motor Function in Chronic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06494020
- Acronym / sponsor ID
- 20230228
- Conditions
- Spinal Cord Injury Cervical, Spastic
- Keywords
- Transcutaneous, Transcutaneous Cervical Spinal Cord Stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- ONWARD Medical, Inc., United States Department of Defense
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 10 Jul 2024 (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.
The goal of this study is to understand the effects of combined task practice with transcutaneous cervical spinal cord stimulation. The study will explore the effect of higher stimulation frequencies on spasticity. Transcutaneous stimulation has been shown to improve motor function in some individuals with chronic spinal cord injury. The study intends to explore scientifically the association between higher stimulation frequencies and spasticity/hypertonicity.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Task Practice with stimulation | Experimental | Other: Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS)Participants in this group will receive combined Transcutaneous cervical spinal cord stimulation with task practice for up to 2 months. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 22-70 years of age
- Non-progressive cervical spinal cord injury
- Minimum 12 months year post-injury.
- American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D.
- Able to take part in upper extremity therapy procedures.
Key exclusion criteria (19 listed)
- Has any unstable or significant medical condition that is likely to interfere with study procedures like severe neuropathic pain, depression, mood disorders, or other cognitive disorders.
- Has uncontrolled cardiopulmonary disease or cardiac symptoms.
- Requires ventilator support.
- Has been diagnosed with autonomic dysreflexia that is severe, unstable, and uncontrolled.
- Has an autoimmune etiology of spinal cord dysfunction/injury
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 |
|---|---|---|
| Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS)Hand rehabilitative tasks ( for gross hand movement, grasp and pinch tasks) will be done by participants during which time the participant will receive TcSCS. This will be done three times a week for 60 minutes. | Other | Task Practice with stimulation |
Primary outcome
Change in motor performance as measured by The Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP) test
Time frame: baseline, up to 4 months
GRASSP is a multimodal test that measures sensorimotor and prehension function in three domains that are important for the description of arm and hand functions, namely strength, sensation and prehension strength. It is an ordinal scale (minimum value = 0, maximum value = 100) with higher scores indicating better performance. There is a sensation category ordinal scale (minimum value = 0 maximum value = 24) that measures sensation where higher scores indicate greater sensation. The Prehension performance category has an ordinal scale (minimum value = 0 maximum value = 40) that measures prehension where higher scores indicate greater ability.
1 secondary outcome
Change in Spasticity as measured by Modified Ashworth Scale (MAS)
Time frame: baseline, up to 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- 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.
James Guest, MD, PhD principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS) in people with Spinal Cord Injury Cervical and Spastic, run by University of Miami at 2 sites in United States.
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 11 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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 motor performance as measured by The Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP) test (time frame: baseline, up to 4 months). 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 Aug 2026.