Back to search results

Spinal Cord Stimulation for Functional Recovery in Tetraplegia

This study is investigating if a non-invasive treatment called transcutaneous electrical spinal stimulation (TESS) can help improve arm and hand movement in people with spinal cord injuries (SCI). TESS delivers small electrical pulses to your spine at C5-6. Researchers will compare TESS with a sham-TESS (inactive stimulation) and combine it with motor training, where you'll practice repetitive arm and hand movements. The study aims to see how TESS affects your upper-limb muscles and if it can improve your ability to reach and grasp. Success will be measured by changes in muscle responses and improvements in your GRASSP Test scores, which assess hand function. The study is currently recruiting 86 Veterans, aged 18-70, with chronic cervical SCI (at least one year after injury, at C8 or above).

Study design
This interventional study plans to enroll 86 participants and involves different groups receiving either TESS or sham-TESS, combined with motor training.
What's involved
You would participate in two randomized sessions initially, then potentially 20 sessions (3-5 per week) involving TESS or sham-TESS and motor tasks over an average of 5 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be followed through study completion (average of 5 weeks) and during a 6-month follow-up period.

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

NCT05157282

Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia

Recruiting
NAAges 18–70InterventionalTreatment
VA Office of Research and Development
~86 participants
Updated 2026-01-16 on ClinicalTrials.gov
What's tested:TESSTrainingMotor Tasksham-TESS

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in amplitude of Motor evoked potential size
Measured over Change from baseline at study completion, average of 5 weeks
+2 more outcomes measured

Conditions

Spinal Cord Injury

Explore related trials

Spinal Cord Injury

Where it's being run

2 sites across 1 states
Illinois2

Study leadership

  • Monica A Perez, PhD · PRINCIPAL_INVESTIGATOR · Edward Hines Jr. VA Hospital, Hines, IL

Who to contact

Monica A Perez, PhD
[email protected]
(312) 238-2886
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Male and female Veterans between 18-70 years
Chronic SCI (1 year of injury)
Cervical injury at C8 or above - damage between cervical spinal segments will be confirmed using MRI \[preliminary data (Benavides et al., 2020) and analysis of MRIs in \~100 participants with cervical SCI confirm that the investigators can meet our recruitment goals. Note that most SCI in humans damage several spinal cord segments
Verification of damage to cervical spinal segments will ensure that TESS electrodes will target the injured spinal cord (Benavides et al., 2020)
Intact or impaired, but not absent, innervations in dermatomes C6, C7 and C8 during light touch and pin prick stimulus using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) sensory scores as tested before in our studies (Bunday and Perez, 2012; Bunday et al., 2018; Benavides et al., 2020; Jo and Perez, 2020)
Able to produce a visible power grip with one hand
Can score a minimum of two (2) in the cylindrical grasp the "Prehension Ability" GRASSP
This criterion was selected to ensure that hand impairment will not interfere with the ability to perform training and the proposed tests
Males and females (18-70 years)
Right-handed
Able to complete grasping

Exclusion

Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
Any debilitating disease prior to the SCI that caused exercise intolerance
Premorbid, ongoing major depression or psychosis, altered cognitive status
History of head injury or concussion, skull fractures (or any skull deficit), unexplained headaches in the last 6 months, or stroke
Pacemaker
Metal plate in skull
History of seizures
Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold, such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants
Pregnant females
Ongoing cord compression, or a syrinx in the spinal cord, or one who suffers from a spinal cord disease such as spinal stenosis, spina bifida, or herniated cervical disk

What this trial measures

  • Changes in amplitude of Motor evoked potential sizeChange from baseline at study completion, average of 5 weeks

    Ten stimuli (0.2 Hz) will be delivered at each intensity to plot the mean peak-to-peak amplitude of the MEP from the non-rectified response against the TMS intensity in each subject (MEP recruitment curve).

  • Change in GRASSP TestThrough study completion(average of 5 weeks) and during 6-month follow-up

    The GRASSP will be used to asses several domains of arm/hand function in humans with cervical SCI, specifically assessing three domains of hand function: 1) strength, 2) sensibility, and 3) prehension. The time to administer the test is \~45 min. The GRASSP has 5 subsets: * Dorsal sensation: (3 locations, each scored 0-4, sum=0-12) * Palmar sensation: (3 locations, each scored 0-4, sum=0-12) * Strength: (10 muscles of arm and hand, motor score 0-5, sum=0-50) * Prehension ability: (3 grasps (cylindrical, lateral key, tip to tip), each scored 0-4, sum=0-12) * Prehension performance: There are 6 prehension tasks. Pouring water from a bottle, opening jars, picking up and turning a key, transferring 9 pegs from board to board, picking up four coins and place in slots, screwing four nuts onto bolts. Each task is scored 0-5, sum=0-30.

  • Changes in amplitude of cervicomedullary motor evoked potential sizeChange from baseline at study completion, average of 5 weeks

    Ten Transcranial magnetic stimuli (TMS) will be delivered to plot the mean peak-to-peak amplitude of the motor and cervicomedullary evoked potentials (MEPs and CMEPs, respectively) from the non-rectified response against the TMS intensity in each subject (MEP/CMEP recruitment curves).