Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia

Part of paid clinical trials in Chicago, Illinois.

Sponsor
VA Office of Research and Development
Study ID
NCT05157282
Status
Recruiting
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Conditions

  • Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • TESS — DEVICE
    Small stimulation pulses will be given to the spine at C5-6 in a non invasive manner.
  • Training — OTHER
    The participant will be instructed to do repetitive motor movements with their arm or hand.
  • Motor Task — OTHER
    Participants will be asked to perform specific motor tasks or movements with their fingers, hands, and arms.
  • sham-TESS — DEVICE
    Small sham stimulation pulses will be given to the spine at C5-6 in a non invasive manner.

Study Details

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.

Key Dates

Start date
Jan 25, 2023
Status verified
Jan 2026
Primary completion
Jan 29, 2027
Completion
Feb 1, 2027

Study Design

Enrollment
86 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active TESS Group 1
    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.
  • Sham Comparator: Sham TESS Group 1
    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.
  • Active Comparator: Active TESS + Training
    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).

Primary Outcome Measure

Changes in amplitude of Motor evoked potential size [ Time Frame: Change from baseline at study completion, average of 5 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Shirley Ryan AbilityLabChicagoIllinois60611
Monica A Perez, PhD
[email protected]
312-238-2886
Edward Hines Jr. VA Hospital, Hines, ILHinesIllinois60141-3030
Bing Chen, PhD MD MEd
[email protected]
(312) 238-7895
Monica A Perez, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Shirley Ryan AbilityLab· Chicago, ILEdward Hines Jr. VA Hospital, Hines, IL· Hines, IL

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