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

NCT06520020 | Recruiting DMC FDA Device

• 1 other identifier: 96620
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Stimulation; Transcutaneous; MagStim; Transcranial; Magnetic

Outcome Measures

Primary Outcomes (12)

• International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)

  An empirically validated and open worksheet for evaluation of sensation from C2 to S4-5, and motor strength of all major limb myotomes from C5-T1 and L2-S1. This determines the neurologic level of injury (NLI) and severity of motor and sensory completeness, with sensorimotor complete, sensory incomplete, motor incomplete without anti-gravity strength, motor incomplete with anti-gravity strength, and no significant deficit.

  Twelve Months

• ASIA Impairment Scale (ASIA / AIS)

  The product of the ISNCSCI examination includes a standard motor score (0-5) in five muscle groups in upper and lower extremity bilaterally with total extremity motor score of 100 (5 x \[5 upper + 5 lower\] x 2).

  Twelve Months

• Modified Japanese Orthopaedic Association (mJOA)

  Validated in cervical myelopathy, the mJOA scale is a patient reported functional scale with 18 points assessing four domains, including: upper extremity (0 - 7), lower extremity (0-7), sensory (0-3), and micturition (0-3). This scale is further divided into severe (\</=11), moderate (12-14), and mild (\>/=15), with scores \<8 reflecting inability to perform clinical assessments (and are excluded).

  Perioperative

• Blood Pressure

  Systolic and diastolic. Measured in mmHg

  Perioperative

• Orthostatic Blood Pressure

  As defined by a sustained reduction in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of 10 mmHg within three minutes of standing after being supine for five minutes.

  Perioperative

• Post-Void Residual

  Defined as the amount of urine remaining in the bladder following urination. Measured in milliliters.

  Perioperative

• Upper Extremity: Grip Strength

  Dynamometry measuring grip strength of both hands with participant directed to squeeze a force gauge between their thumb base and fingers at the distal interphalangeal joint. Average of three attempts, measured in kg of force.

  Twelve Months

• GRASSP

  Gross and fine motor function of the hand is tested with subcomponents while manipulating common, but standardized, objects including jar and water bottle opening, grasping of key, coin, nut and bolt, and nine-peg test. Measured in time (seconds) to completion and/or percentage of completion in a given time period.

  Twelve Months

• Lower Extremity: 10 Meter Walk Test

  The participant is instructed to walk as fast and accurately as possible across a 10- meter length of hallway, without adaptive devices. This can be consistently recorded whether starting at rest or when already walking 'at speed'. Measured in seconds.

  Twelve Months

• GAITRite Walking Assessment

  Quantitative analysis of gait using an electronic pressure mat, measured with gait stability ratio (single stance time / double stance time). Measured in time (seconds) and distance (centimeters).

  Twelve Months

• SCIM-vIII (PROM)

  self-reported questionnaire comprised of 19 questions on daily tasks with a total score between 0 and 100 and subscales for self-care, respiration \& sphincter management, and mobility.

  Twelve Months

• WHOQOL-BREF

  A questionnaire validated in, but not specific to, people with SCI. The WHOQOL-BREF been found to have excellent reliability, adequate-to-excellent validity with complete and incomplete SCI, and acceptable ceiling or floor effects. Measured as a raw score and converted to a percentage with higher values indicating a more positive result.

  Twelve Months

Secondary Outcomes (4)

• Adverse Event Rate

  Twelve Months

• Serious Adverse Event Rate

  Twelve Months

• Adherence to Protocol

  Twelve Months

• Data Collection and Monitoring

  Twelve Months

Study Arms (3)

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

EXPERIMENTAL

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

Device: Transcutaneous Spinal Cord Stimulation (Tc-SCS)

Traumatic Spinal Cord Injury (tSCI) - Early/Acute

EXPERIMENTAL

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

Device: Transcutaneous Spinal Cord Stimulation (Tc-SCS)

Traumatic Spinal Cord Injury (tSCI) - Chronic

ACTIVE COMPARATOR

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.

Device: Transcutaneous Spinal Cord Stimulation (Tc-SCS)

Interventions

Transcutaneous Spinal Cord Stimulation (Tc-SCS) DEVICE

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.

Also known as: Electrical Stimulation

Non-Traumatic Spinal Cord Injury (ntSCI,) DCM - Progressive; Traumatic Spinal Cord Injury (tSCI) - Chronic; Traumatic Spinal Cord Injury (tSCI) - Early/Acute

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Francis Farhadi: lead

Study Sites (1)

University of Kentucky - Chandler Medical Center

Lexington, Kentucky, 40536-0298, United States

RECRUITING

MeSH Terms

Interventions

Electric Stimulation

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Jared Wilcox, MD, PhD

  University of Kentucky Neurosurgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Neurosurgery

Model Details: The study will be a non-randomized, non-blinded pilot study to analyze the safety and feasibility of a non-significant risk device, using transcutaneous spinal cord stimulation. We aim 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.

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 25, 2024
• Study Start: October 23, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

US (1)