BridgeMD
New treatment option for Spinal Cord Injury Cervical
Official title Task Practice and Spinal Cord Stimulation
ClinicalTrials.gov ID: NCT06494020
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 70
You may be able to join if
- 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.
You likely can't join if
- Has any unstable or significant medical condition that is likely to interfere with study procedures like severe neuropathic pain, depression, mood...
- 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
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.