NCT06494020 · University of Miami
Task Practice and Spinal Cord Stimulation
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- 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.
Exclusion criteria
- 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
- 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.
Where
- Miami, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2025 · Source of record for eligibility and locations