Spinal Cord InjuryNCT05157282
Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia
A study testing TESS, Training and Motor Task in people with Spinal Cord Injury, run by VA Office of Research and Development at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- TESS, Training and Motor Task
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jan 2023to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Monica A Perez, PhD, 312-238-2886, mperez04@sralab.org
- Recruiting
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
Bing Chen, PhD MD MEd, (312) 238-7895, bing.chen@va.gov
Monica A Perez, PhD
About this study
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.
Read the detailed description
Current studies demonstrate that electrical spinal stimulation, either invasive or noninvasive, can play an important role in rehabilitation strategies aimed at improving limb function in humans with SCI (Taccola et al., 2018). Among current stimulation strategies, one of the most promising candidates to emerge in recent years is transcutaneous electrical spinal stimulation (TESS). TESS is a noninvasive technique that can be tailored to the needs of each individual, where several segments of the spinal cord can be stimulated at the same time, and delivery can be programed to interact with a rehabilitation strategy during functional movements, such as reaching or grasping. A key element to TESS is its ability to access spared spinal cord networks with minimal discomfort. Although promising, the knowledge of TESS remains limited in scope and more studies are needed to further identify its efficacy.
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
- Spinal Cord Injury
- Being tested
- TESS, Training, Motor Task, sham-TESS
- Keywords
- Spinal Cord Injury, Motor Function, Reaching, Grasping, Hand Movement
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TESSDevice
Also called NeoStim-5
Small stimulation pulses will be given to the spine at C5-6 in a non invasive manner.
TrainingOther
Also called Massed Practice Training
The participant will be instructed to do repetitive motor movements with their arm or hand.
Motor TaskOther
Participants will be asked to perform specific motor tasks or movements with their fingers, hands, and arms.
sham-TESSDevice
Also called NeoStim-5
Small sham stimulation pulses will be given to the spine at C5-6 in a non invasive manner.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: Device: TESS; Other: Training; Other: Motor Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: Change from baseline at study completion, average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start25 Jan 2023
- Primary completion29 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Transcutaneous electrical spinal stimulation (TESS)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Monica A Perez, PhD, Principal investigator, Edward Hines Jr. VA Hospital, Hines, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157282
- Sponsor's protocol ID
- B3715-R
- Status last verified
- Jan 2026
- First submitted
- 24 Nov 2021
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia
- ClinicalTrials.gov ID
- NCT05157282
- Acronym / sponsor ID
- B3715-R
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury, Motor Function, Reaching, Grasping, Hand Movement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 29 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Current studies demonstrate that electrical spinal stimulation, either invasive or noninvasive, can play an important role in rehabilitation strategies aimed at improving limb function in humans with SCI (Taccola et al., 2018). Among current stimulation strategies, one of the most promising candidates to emerge in recent years is transcutaneous electrical spinal stimulation (TESS). TESS is a noninvasive technique that can be tailored to the needs of each individual, where several segments of the spinal cord can be stimulated at the same time, and delivery can be programed to interact with a rehabilitation strategy during functional movements, such as reaching or grasping. A key element to TESS is its ability to access spared spinal cord networks with minimal discomfort. Although promising, the knowledge of TESS remains limited in scope and more studies are needed to further identify its efficacy.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Transcutaneous electrical spinal stimulation (TESS)
| Arm | Type | Receives |
|---|---|---|
| Active TESS Group 1 | Active comparator | Device: TESS, Other: Motor Task, Device: sham-TESSSubjects 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 TESS Group 1 | Sham comparator | Device: TESS, Other: Motor Task, Device: sham-TESSSubjects 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 TESS + Training | Active comparator | Device: TESS, Other: Training, Other: Motor TaskDevelop 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TESSAlso: NeoStim-5Small stimulation pulses will be given to the spine at C5-6 in a non invasive manner. | Device | Active TESS + Training, Active TESS Group 1, Sham TESS Group 1 |
| TrainingAlso: Massed Practice TrainingThe participant will be instructed to do repetitive motor movements with their arm or hand. | Other | Active TESS + Training |
| Motor TaskParticipants will be asked to perform specific motor tasks or movements with their fingers, hands, and arms. | Other | Active TESS + Training, Active TESS Group 1, Sham TESS Group 1 |
| sham-TESSAlso: NeoStim-5Small sham stimulation pulses will be given to the spine at C5-6 in a non invasive manner. | Device | Active TESS Group 1, Sham TESS Group 1 |
Primary outcome
Changes in amplitude of Motor evoked potential size
Time frame: Change 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 Test
Time frame: Through 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 size
Time frame: Change 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injury
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Monica A Perez, PhD principal investigator
Edward Hines Jr. VA Hospital, Hines, IL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TESS, Training and Motor Task in people with Spinal Cord Injury, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica A Perez, PhD ((312) 238-2886, mperez04@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in amplitude of Motor evoked potential size (time frame: Change from baseline at study completion, average of 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.