Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia

NCT05157282 | Recruiting FDA Device

• 1 other identifier: B3715-R
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

Brief Summary

In support of the long-term goal of developing new strategies to increase limb function after SCI, the objectives of this proposal are to: 1) Examine the behavioral and physiological effects of TESS on upper-limb muscles after cervical SCI; and 2) Maximize the recovery of reaching and grasping potential by using tailored TESS in a task-specific manner with motor training. Veterans with cervical spinal injuries and healthy volunteers will be recruited for this study.

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injury; Motor Function; Reaching; Grasping; Hand Movement

Outcome Measures

Primary Outcomes (3)

• Changes in amplitude of Motor evoked potential size

  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 from baseline at study completion, average of 5 weeks

• Change in GRASSP Test

  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.

  Through study completion(average of 5 weeks) and during 6-month follow-up

• Changes in amplitude of cervicomedullary motor evoked potential size

  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).

  Change from baseline at study completion, average of 5 weeks

Study Arms (3)

Active TESS Group 1

ACTIVE COMPARATOR

Subjects with SCI and without SCI (controls) will participate in two testing sessions, separated by 2-3 days, using a crossover design. In each session, active transcutaneous electrical spinal stimulation (TESS) will be applied over the cervical spinal cord. Functional and physiological measures will be acquired before and after each session.

Device: TESS; Other: Motor Task; Device: sham-TESS

Sham TESS Group 1

SHAM COMPARATOR

Subjects with SCI and without SCI (controls) will participate in two testing sessions, separated by 2-3 days, using a crossover design. In each session, sham transcutaneous electrical spinal stimulation (sham-TESS) will be applied over the cervical spinal cord. Functional and physiological measures will be acquired before and after each session.

Device: TESS; Other: Motor Task; Device: sham-TESS

Active TESS + Training

ACTIVE COMPARATOR

Develop methodologies to promote recovery of reaching and grasping movements. To accomplish this goal, the investigators will combine TESS applied in a closed-loop manner with massed practice upper-limb training. Participants will be assigned to one of three groups in a randomized order for a controlled design: \[1) Closed-loop TESS applied during grasping + training, 2) Closed-loop TESS applied during reaching + training, and 3) Closed-loop TESS applied during grasping \& reaching + training.\] TESS for 20-min will be followed by 60 min of massed practice exercise training (total=20 sessions).

Device: TESS; Other: Training; Other: Motor Task

Interventions

TESS DEVICE

Small stimulation pulses will be given to the spine at C5-6 in a non invasive manner.

Also known as: NeoStim-5

Active TESS + Training; Active TESS Group 1; Sham TESS Group 1

Training OTHER

The participant will be instructed to do repetitive motor movements with their arm or hand.

Also known as: Massed Practice Training

Active TESS + Training

Motor Task OTHER

Participants will be asked to perform specific motor tasks or movements with their fingers, hands, and arms.

Active TESS + Training; Active TESS Group 1; Sham TESS Group 1

sham-TESS DEVICE

Small sham stimulation pulses will be given to the spine at C5-6 in a non invasive manner.

Also known as: NeoStim-5

Active TESS Group 1; Sham TESS Group 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Monica A Perez, PhD

  Edward Hines Jr. VA Hospital, Hines, IL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica A Perez, PhD

CONTACT

(312) 238-2886; mperez04@sralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know if they receive real or sham stimulation
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Transcutaneous electrical spinal stimulation (TESS)

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 14, 2021
• Study Start: January 25, 2023
• Primary Completion (Estimated): January 29, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)