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Tests treatment safety and results for Spinal Cord Stimulation
Official title Evaluating Safety and Feasibility of Transcutaneous Spinal Cord Stimulation Following Traumatic and Non-Traumatic Spinal Cord Injury: A Pilot Study
ClinicalTrials.gov ID: NCT06520020
What this study is testing
- What it's testing
- The study will be a non-randomized, non-blinded pilot study to analyze the safety and feasibility of a non-significant risk device, transcutaneous spinal cord stimulation. The aim is to include 30 total patients, 10 patients in each of 3 groups: 1.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age: = 18 years and = 80 years.
- Written informed consent by patient and/or legal authorized representative (LAR).
- No other life-threatening condition.
- No evidence of sepsis.
- No evidence of superficial skin infection at site of surgery and intervention.
You likely can't join if
- Any concomitant impairment of the upper and lower limb at baseline that could potentially confound the neurologic assessments; including but not...
- mJOA of \>= 15 and \<= 7, or AIS grade E tSCI at baseline assessment.
- Currently involved in another non-observational ntSCI or tSCI study, or receiving another treatment drug, that could interfere with recordings and...
- Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation, at discretion of the treating surgeon...
- Unable to commit to the follow-up schedule.
- Recent history of regular substance abuse (illicit drugs, alcohol), which in the opinion of the investigator would interfere with the subject's...
See the full eligibility criteria
- Age: = 18 years and = 80 years.
- Written informed consent by patient and/or legal authorized representative (LAR).
- No other life-threatening condition.
- No evidence of sepsis.
- No evidence of superficial skin infection at site of surgery and intervention.
- An established diagnosis of either:
- cervical myelopathy with modified Japanese Orthopaedic Association score of 8-14, or
- acute cervical / thoracic SCI with ASIA Impairment Scale grade A-D (as assessed within 72 hours of injury) with neurologic level of injury (NLI) from C2 to T12.
- The ability to undergo, or have had, surgical intervention. -. The ability to undergo transcutaneous intervention including study procedures in the posterior cervical or thoracic midline at or after 14 days from surgery.
- Any concomitant impairment of the upper and lower limb at baseline that could potentially confound the neurologic assessments; including but not limited to traumatic or disease conditions like brachial plexus injury...
- mJOA of \>= 15 and \<= 7, or AIS grade E tSCI at baseline assessment.
- Currently involved in another non-observational ntSCI or tSCI study, or receiving another treatment drug, that could interfere with recordings and confound adverse events.
- Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation, at discretion of the treating surgeon and/or principal investigator.
- Unable to commit to the follow-up schedule.
- Recent history of regular substance abuse (illicit drugs, alcohol), which in the opinion of the investigator would interfere with the subject's participation in the study.
- Any condition likely to result in the patient's death within the next 12 months.
- Prisoner.
- Pregnancy.
- Cardiac pacemaker dependent, unable to undergo electrical stimulation.
- Brain implant, skull prosthesis, plate and screws limiting transcranial stimulation.
- Tattoo at site of skin electrode that causes heat/pain during stimulation.
- people who in the opinion of the investigator are not suitable for inclusion in the study, with reason documented.
The study team makes the final eligibility decision.
Where it's taking place
- Lexington, Kentucky, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lexington, Kentucky, 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.