Recruiting

Transcutaneous Spinal Cord Stimulation

Sponsor:

Francis Farhadi

Code:

NCT06520020

Conditions

Spinal Cord Stimulation

Electric Stimulation Therapy

Traumatic Spinal Cord Injury

Cervical Myelopathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous Spinal Cord Stimulation (Tc-SCS)

Study Details

Brief summary:

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.

Conditions

Spinal Cord Stimulation

Electric Stimulation Therapy

Traumatic Spinal Cord Injury

Cervical Myelopathy

Study ID

NCT06520020

Start date

Oct 23, 2024

Status verified date

Jul, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion 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.

Exclusion Criteria:

  • 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.
  • 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 interventional 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.
  • Subjects who in the opinion of the investigator are not suitable for inclusion in the study, with reason documented.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Non-Traumatic Spinal Cord Injury (ntSCI,) DCM - Progressive

Non-traumatic spinal cord injury (ntSCI) with diagnosis of degenerative cervical myelopathy (DCM) and offered surgical intervention. Prospective.

experimental: Traumatic Spinal Cord Injury (tSCI) - Early/Acute

Traumatic spinal cord injury (tSCI) screened during the hospital admission when cervical/thoracic spinal injury was diagnosed. 2-6 weeks after injury.

active comparator: Traumatic Spinal Cord Injury (tSCI) - Chronic

Delayed traumatic spinal cord injury (tSCI) screened 6-24 months after acute cervical/thoracic spinal injury. The use of transcutaneous spinal cord stimulation (Tc-SCS) in chronic SCI delivered in the delayed timeframe is relatively well studied, and therefore will serve as the control arm.

Interventions

Transcutaneous Spinal Cord Stimulation (Tc-SCS)

This study will employ a DS8R Biphasic Constant Current Stimulator (Digitimer, Hertfordshire, United Kingdom) to administer transcutaneous (Tc) SCS through bursts of biphasic rectangular pulses, each lasting 400 μs to 1 ms, at 30 Hz frequency on a carrier frequency is 10 kHz. The intensity of stimulation will be 120% the threshold intensity that elicits visible twitch or motor evoked potential (MEP) triggered in the biceps brachii (BB) or abductor pollicis brevis (APB) muscle for upper extremity, and quadriceps femoris (QF) or tibialis anterior (TA) in the lower extremity.

Primary outcome measure

  • International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) [ Time Frame: Twelve Months ]
  • ASIA Impairment Scale (ASIA / AIS) [ Time Frame: Twelve Months ]
  • Modified Japanese Orthopaedic Association (mJOA) [ Time Frame: Perioperative ]
  • Blood Pressure [ Time Frame: Perioperative ]
  • Orthostatic Blood Pressure [ Time Frame: Perioperative ]
  • Post-Void Residual [ Time Frame: Perioperative ]
  • Upper Extremity: Grip Strength [ Time Frame: Twelve Months ]
  • GRASSP [ Time Frame: Twelve Months ]
  • Lower Extremity: 10 Meter Walk Test [ Time Frame: Twelve Months ]
  • GAITRite Walking Assessment [ Time Frame: Twelve Months ]
  • SCIM-vIII (PROM) [ Time Frame: Twelve Months ]
  • WHOQOL-BREF [ Time Frame: Twelve Months ]

Central Contacts and Locations

Central contacts

H. Francis Farhadi, MD, PhD

859-323-5661francis.farhadi@uky.edu

Kris P Dyer, MPH, BS

859-323-4533kris.dyer@uky.edu

Locations

University of Kentucky - Chandler Medical Center

Recruiting

Lexington, Kentucky, United States, 40536-0298

Contacts

Francis H Farhadi, MD, PhD

859-562-0247francis.farhadi@uky.edu

Kris P Dyer, MPH, BS

859-323-4533kris.dyer@uky.edu

More Information

Sponsor

Francis Farhadi

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • Stimulation
  • Transcutaneous
  • MagStim
  • Transcranial
  • Magnetic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Francis Farhadi on 2026-07-07.