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Transcutaneous Spinal Cord Stimulation for Spinal Cord Injury

This study is testing the safety and feasibility of Transcutaneous Spinal Cord Stimulation (Tc-SCS), a device that delivers electrical pulses through the skin to the spinal cord. It aims to see if Tc-SCS can help people with spinal cord injury (SCI), both from trauma and other causes like cervical myelopathy (a condition affecting the neck part of the spinal cord). Researchers will look at how well participants' neurological function improves over 12 months. The study plans to enroll 30 participants aged 18 to 80 years who do not have other life-threatening conditions or infections. The current recruitment status is unclear.

Study design
This is a pilot study that is not randomized or blinded, meaning participants will know if they are receiving the intervention. It aims to enroll 30 participants across three groups.
What's involved
You would be assessed at the start and at various times over a 12-month period, including during admission, rehabilitation, and follow-up appointments.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after the intervention to assess outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06520020

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

Recruiting
NAAges 18–80InterventionalTreatment
Francis Farhadi
~30 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:Transcutaneous Spinal Cord Stimulation (Tc-SCS)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Measured over Twelve Months
+11 more outcomes measured

Conditions

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

Explore related trials

Cervical myelopathySpinal Cord Injury

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

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

Who to contact

H. Francis Farhadi, MD, PhD
[email protected]
859-323-5661
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

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

    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.

  • ASIA Impairment Scale (ASIA / AIS)Twelve Months

    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).

  • Modified Japanese Orthopaedic Association (mJOA)Perioperative

    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).

  • Blood PressurePerioperative

    Systolic and diastolic. Measured in mmHg

  • Orthostatic Blood PressurePerioperative

    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.

  • Post-Void ResidualPerioperative

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

  • Upper Extremity: Grip StrengthTwelve Months

    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.

  • GRASSPTwelve Months

    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.

  • Lower Extremity: 10 Meter Walk TestTwelve Months

    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.

  • GAITRite Walking AssessmentTwelve Months

    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).

  • SCIM-vIII (PROM)Twelve Months

    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.

  • WHOQOL-BREFTwelve Months

    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.