RECRUITING

Evaluating Safety and Feasibility of Transcutaneous Spinal Cord Stimulation Following Traumatic and Non-Traumatic Spinal Cord Injury: A Pilot Study

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Conditions

Spinal Cord StimulationElectric Stimulation TherapyTraumatic Spinal Cord InjuryCervical MyelopathyStimulationTranscutaneousMagStimTranscranialMagnetic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. Non-traumatic spinal cord injury (ntSCI) with diagnosis of degenerative cervical myelopathy and offered surgical intervention. 2. Early tSCI screened during the hospital admission when cervical/thoracic spinal injury was diagnosed. 3. Delayed tSCI (control) screened 6-24 months after acute cervical/thoracic spinal injury.

Official Title

Evaluating Safety and Feasibility of Transcutaneous Spinal Cord Stimulation Following Traumatic and Non-Traumatic Spinal Cord Injury: A Pilot Study

Quick Facts

Study Start:2024-10-23
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06520020

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: = 18 years and = 80 years.
  2. * Written informed consent by patient and/or legal authorized representative (LAR).
  3. * No other life-threatening condition.
  4. * No evidence of sepsis.
  5. * No evidence of superficial skin infection at site of surgery and intervention.
  6. * An established diagnosis of either:
  7. * cervical myelopathy with modified Japanese Orthopaedic Association score of 8-14, or
  8. * 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.
  9. * 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.
  1. * 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, peripheral neuropathy, spinal hematoma, transverse myelitis, non-compressive myelopathy, dementia, and Parkinson's disease.
  2. * mJOA of \>= 15 and \<= 7, or AIS grade E tSCI at baseline assessment.
  3. * Currently involved in another non-observational ntSCI or tSCI study, or receiving another interventional drug, that could interfere with recordings and confound adverse events.
  4. * Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation, at discretion of the treating surgeon and/or principal investigator.
  5. * Unable to commit to the follow-up schedule.
  6. * 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.
  7. * Any condition likely to result in the patient's death within the next 12 months.
  8. * Prisoner.
  9. * Pregnancy.
  10. * Cardiac pacemaker dependent, unable to undergo electrical stimulation.
  11. * Brain implant, skull prosthesis, plate and screws limiting transcranial stimulation.
  12. * Tattoo at site of skin electrode that causes heat/pain during stimulation.
  13. * Subjects who in the opinion of the investigator are not suitable for inclusion in the study, with reason documented.

Contacts and Locations

Study Contact

H. Francis Farhadi, MD, PhD
CONTACT
859-323-5661
francis.farhadi@uky.edu
Kris P Dyer, MPH, BS
CONTACT
859-323-4533
kris.dyer@uky.edu

Principal Investigator

Jared Wilcox, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Kentucky Neurosurgery

Study Locations (Sites)

University of Kentucky - Chandler Medical Center
Lexington, Kentucky, 40536-0298
United States

Collaborators and Investigators

Sponsor: Francis Farhadi

  • Jared Wilcox, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Kentucky Neurosurgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-23
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2024-10-23
Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

  • Stimulation
  • Transcutaneous
  • MagStim
  • Transcranial
  • Magnetic

Additional Relevant MeSH Terms

  • Spinal Cord Stimulation
  • Electric Stimulation Therapy
  • Traumatic Spinal Cord Injury
  • Cervical Myelopathy