Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia
NCT ID: NCT05157282
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
86 participants
INTERVENTIONAL
2023-01-25
2027-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia
NCT05423600
Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury
NCT03184792
Hand Function for Tetraplegia
NCT00890916
Combined Nerve and Tendon Transfer for the Restoration of Hand Function in Individuals With Tetraplegia
NCT04276181
TCES for Upper Limb Function in Cervical SCI
NCT05801536
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In Aim 1, subjects will participate in two randomized sessions: 1) TESS, and 2) sham-TESS.\] In Aim 2, the investigators will examine the effect of stimulation and training for a total of 20 sessions (3 to 5 per week). Participants will be randomly assigned to: \[1) Closed-loop TESS applied during grasping + training, or 2) Closed-loop TESS applied during reaching + training.\]
AIM 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, TESS or sham-TESS will be applied over the cervical spinal cord. Functional and physiological measures will be acquired before and after each session.
AIM 2 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 using a sham 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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
TESS
Small stimulation pulses will be given to the spine at C5-6 in a non invasive manner.
Motor Task
Participants will be asked to perform specific motor tasks or movements with their fingers, hands, and arms.
sham-TESS
Small sham stimulation pulses will be given to the spine at C5-6 in a non invasive manner.
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.
TESS
Small stimulation pulses will be given to the spine at C5-6 in a non invasive manner.
Motor Task
Participants will be asked to perform specific motor tasks or movements with their fingers, hands, and arms.
sham-TESS
Small sham stimulation pulses will be given to the spine at C5-6 in a non invasive manner.
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).
TESS
Small stimulation pulses will be given to the spine at C5-6 in a non invasive manner.
Training
The participant will be instructed to do repetitive motor movements with their arm or hand.
Motor Task
Participants will be asked to perform specific motor tasks or movements with their fingers, hands, and arms.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TESS
Small stimulation pulses will be given to the spine at C5-6 in a non invasive manner.
Training
The participant will be instructed to do repetitive motor movements with their arm or hand.
Motor Task
Participants will be asked to perform specific motor tasks or movements with their fingers, hands, and arms.
sham-TESS
Small sham stimulation pulses will be given to the spine at C5-6 in a non invasive manner.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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
18 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
VA Office of Research and Development
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Monica A Perez, PhD
Role: PRINCIPAL_INVESTIGATOR
Edward Hines Jr. VA Hospital, Hines, IL
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shirley Ryan AbilityLab
Chicago, Illinois, United States
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B3715-R
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.