Spinal Cord InjuriesNCT06225245
Augmenting Upper Limb Function and Functional Neuroplasticity Using Epidural Stimulation of the Cervical Spinal Cord
A study testing Epidural Spinal Stimulation (ESS) and Upper extremity rehabilitation in people with Spinal Cord Injuries and Cervical Spinal Cord Injury, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
This study will test whether spinal stimulation combined with rehabilitation can improve arm and hand function in people with tetraplegia after spinal cord injury. Tetraplegia causes weakness or paralysis in the arms and legs. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Cervical Spinal Cord Injury, Spinal Cord Injury
- What is being tested?
- Epidural Spinal Stimulation (ESS) and Upper extremity rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2024to 1 Jan 2030
- 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 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed stable medical condition for participation by study physician.
- Male or female aged 22 - 70 years old.
- Must provide documentation from personal primary treating physician that reports stable medical condition.
- Able to passively range bilateral upper extremities within normal mobility parameters as defined by study protocol
- Maintain current oral anti-spasticity regimen/dosage as approved by study physician with no change in regular use that may affect study outcomes.
- Six (6) months to 20 years post spinal cord injury.
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- Non-progressive spinal cord injury.
- Chronic spinal cord injury classified as ASIA Impairment Scale (AIS) grade A, B, or C.
- Neurological level of injury above T2.
- Eligible for fMRI per safety questionnaire.
- Women of childbearing potential must agree to the use of an effective means of avoiding pregnancy for the duration of the study
Who cannot join
- Currently involved in another rehabilitation training study.
- Lower motor neuron injury revealed in the upper limbs.
- Stabilization hardware in the cervical spine, preventing implantation of ESS system.
- Active pressure sores, wounds, unhealed bone fractures, peripheral neuropathies, or painful musculoskeletal dysfunction (including contractures in the upper and lower extremities).
- Any ongoing medical condition which would preclude participant from regular physical activity (including but not limited to: ventilator dependence, cardiopulmonary disease, uncontrollable autonomic dysreflexia or orthostatic hypotension, or active urinary tract infections).
- Intrathecal baclofen pump therapy for spasticity.
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- Botox injections to primary upper extremity and trunk musculature within the past 3 months which would result in absence of muscle tone and thus preclude response to electrical stimulation therapy.
- Current or history of neuromuscular conditions (including but not limited to: unhealed ligament of muscle tears in the upper or lower extremities, pain in weight bearing positions for upper and lower extremities).
- Current or history of seizures or cerebral lesions.
- Clinically significant depression, psychiatric disorders, or ongoing drug abuse.
- Currently taking tricyclic anti-depressants, selective serotonin reuptake inhibitors (SSRIs), serotonin nor-epinephrine reuptake inhibitors (SNRI), or bupropion (Wellbutrin).
- Any reason the PI or treating physician may deem as harmful to the participant or inappropriate for the participant to enroll or continue in the study.
- Body Mass Index (BMI) over 30.
- Pregnancy or nursing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Methodist Hospital Research Institute
Houston, Texas, 77030
Dimitry Sayenko, 585-507-1706, sayenkolab@houstonmethodist.org
Dimitry G Sayenko, MD, PhD
About this study
This study will test whether spinal stimulation combined with rehabilitation can improve arm and hand function in people with tetraplegia after spinal cord injury. Tetraplegia causes weakness or paralysis in the arms and legs.
The stimulation sends electrical pulses through a paddle placed near the spinal cord in the neck. Researchers will study changes in arm and hand function and how the brain and spinal cord respond.
Read more
The study has two phases.
Phase 1: Initial testing
Participants will:
- Complete screening to see whether they qualify.
- Have surgery to place a stimulation paddle in the neck, with wires extending outside the body.
- Take part in arm and hand exercises with spinal stimulation.
- Complete tests to measure their response.
The study team will check whether each participant meets the criteria to continue. Those who qualify may choose to enter Phase 2. Those who do not qualify will have the paddle and external wires removed and will not enter Phase 2.
Phase 2: Permanent implant Participants will have surgery to implant a battery that powers the stimulation system. They will continue arm and hand exercises with stimulation. The study team will adjust the settings to support each participant's movement goals.
Read the detailed description
Previous research suggests that epidural spinal stimulation (ESS) can activate nerve networks below a spinal cord injury. This feasibility study will examine the safety and potential effects of cervical ESS, delivered near the spinal cord in the neck, combined with arm and hand rehabilitation.
The study has two aims:
- Assess changes in arm and hand movement and sensation when cervical ESS is paired with rehabilitation.
- Examine how cervical ESS affects brain and spinal cord activity and whether these responses relate to arm and hand function.
Researchers will monitor side effects, skin health, vital signs, and comfort during stimulation.
The study will use several methods to assess changes:
- Nervous system testing, including brain MRI scans and recordings of electrical signals from the spinal cord.
- Three-dimensional cameras and sensors to measure arm, hand, and other joint movements.
- Standardized tests and questionnaires to assess arm and hand function and the ability to perform daily activities.
- Being tested
- Epidural Spinal Stimulation (ESS), Upper extremity rehabilitation
- Keywords
- spinal stimulation, epidural spinal stimulation, neuromodulation, upper extremity function, Spinal cord injury, Tetraplegia, Upper limb function, Arm and hand function, Spinal cord electrophysiology
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Spinal Stimulation (ESS)Device
An implanted paddle array delivers electrical stimulation near the spinal cord in the neck. Settings are adjusted to each participant's tolerance and arm and hand movement goals. Only trained study staff operate the stimulation controller. For participants receiving a permanent implant, home stimulation programs are established and refined before study completion.
Upper extremity rehabilitationBehavioural
Participants complete arm and hand rehabilitation paired with cervical epidural spinal stimulation to work toward their movement goals.
| Study group | Role | What they receive |
|---|---|---|
| Epidural Spinal Stimulation (ESS) | Experimental | Participants receive an initial cervical paddle implant and arm and hand rehabilitation paired with stimulation. Those who meet the protocol's response criteria may choose to receive a permanent battery implant and continue rehabilitation with stimulation. Nonresponders have the paddle and external wires removed. Receives: Device: Epidural Spinal Stimulation (ESS); Behavioral: Upper extremity rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
Primary objectives are to evaluate safety and to quantify the neurophysiological and functional effects of ESS in individuals with SCI.
Safety endpoints: Adverse events throughout the study; wound/skin condition; vital signs; pain and spasticity assessments.
Neurophysiological and functional endpoints: electrophysiological assessments; MRI; functional assessments measuring 3D kinematics to access major joint and body segment assessments; spinal signals.
Measured: Safety: each visit from consent through last visit at week 17, for a total of 17 weeks; then re-assessed monthly after study completion for a period of 12 months. Other: before and after temporary and permanent phases, within 17 weeks of study duration.
Secondary outcomes (2)
Secondary Objective
The secondary objectives are to evaluate the effects of upper extremity rehabilitation paired with ESS on specific arm and hand functions as well as daily activities.
Endpoints: standardized functional and clinical outcomes looking at upper extremity function and effects on daily living.
Measured: Before and after temporary and permanent phases, within 17 weeks of study duration
Tertiary/Exploratory
The exploratory objective is to compare delayed (carry-over) effects following upper extremity rehabilitation training combined with ESS.
Measured: Up to 52 weeks after study ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start6 Aug 2024
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This single-group study has an initial testing stage and a permanent implant stage. Participants receive cervical epidural spinal stimulation through an implanted paddle with externalized wires, paired with upper limb rehabilitation. Participants who meet the study's response criteria may choose to have a battery implanted and continue stimulation with rehabilitation. Those who do not meet these criteria have the paddle and external wires removed and do not continue to the permanent implant stage.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dimitry Sayenko, MD, PhD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225245
- Sponsor's protocol ID
- PRO00037827
- Status last verified
- Oct 2026
- First submitted
- 19 Dec 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is currently no plan to share individual participant data from this study with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Upper Limb Function and Functional Neuroplasticity Using Epidural Stimulation of the Cervical Spinal Cord
- ClinicalTrials.gov ID
- NCT06225245
- Acronym / sponsor ID
- PRO00037827
- Keywords
- spinal stimulation, epidural spinal stimulation, neuromodulation, upper extremity function, Spinal cord injury, Tetraplegia, Upper limb function, Arm and hand function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 25 Jan 2024 (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.
This study will test whether spinal stimulation combined with rehabilitation can improve arm and hand function in people with tetraplegia after spinal cord injury. Tetraplegia causes weakness or paralysis in the arms and legs.
The stimulation sends electrical pulses through a paddle placed near the spinal cord in the neck. Researchers will study changes in arm and hand function and how the brain and spinal cord respond.
The study has two phases.
Phase 1: Initial testing
Participants will:
- Complete screening to see whether they qualify.
- Have surgery to place a stimulation paddle in the neck, with wires extending outside the body.
- Take part in arm and hand exercises with spinal stimulation.
- Complete tests to measure their response.
The study team will check whether each participant meets the criteria to continue. Those who qualify may choose to enter Phase 2. Those who do not qualify will have the paddle and external wires removed and will not enter Phase 2.
Phase 2: Permanent implant Participants will have surgery to implant a battery that powers the stimulation system. They will continue arm and hand exercises with stimulation. The study team will adjust the settings to support each participant's movement goals.
Detailed description
Previous research suggests that epidural spinal stimulation (ESS) can activate nerve networks below a spinal cord injury. This feasibility study will examine the safety and potential effects of cervical ESS, delivered near the spinal cord in the neck, combined with arm and hand rehabilitation.
The study has two aims:
- Assess changes in arm and hand movement and sensation when cervical ESS is paired with rehabilitation.
- Examine how cervical ESS affects brain and spinal cord activity and whether these responses relate to arm and hand function.
Researchers will monitor side effects, skin health, vital signs, and comfort during stimulation.
The study will use several methods to assess changes:
- Nervous system testing, including brain MRI scans and recordings of electrical signals from the spinal cord.
- Three-dimensional cameras and sensors to measure arm, hand, and other joint movements.
- Standardized tests and questionnaires to assess arm and hand function and the ability to perform daily activities.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This single-group study has an initial testing stage and a permanent implant stage. Participants receive cervical epidural spinal stimulation through an implanted paddle with externalized wires, paired with upper limb rehabilitation. Participants who meet the study's response criteria may choose to have a battery implanted and continue stimulation with rehabilitation. Those who do not meet these criteria have the paddle and external wires removed and do not continue to the permanent implant stage.
| Arm | Type | Receives |
|---|---|---|
| Epidural Spinal Stimulation (ESS) | Experimental | Device: Epidural Spinal Stimulation (ESS), Behavioral: Upper extremity rehabilitationParticipants receive an initial cervical paddle implant and arm and hand rehabilitation paired with stimulation. Those who meet the protocol's response criteria may choose to receive a permanent battery implant and continue rehabilitation with stimulation. Nonresponders have the paddle and external wires removed. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Confirmed stable medical condition for participation by study physician.
- Male or female aged 22 - 70 years old.
- Must provide documentation from personal primary treating physician that reports stable medical condition.
- Able to passively range bilateral upper extremities within normal mobility parameters as defined by study protocol
- Maintain current oral anti-spasticity regimen/dosage as approved by study physician with no change in regular use that may affect study outcomes.
Key exclusion criteria (14 listed)
- Currently involved in another rehabilitation training study.
- Lower motor neuron injury revealed in the upper limbs.
- Stabilization hardware in the cervical spine, preventing implantation of ESS system.
- Active pressure sores, wounds, unhealed bone fractures, peripheral neuropathies, or painful musculoskeletal dysfunction (including contractures in the upper and lower extremities).
- Any ongoing medical condition which would preclude participant from regular physical activity (including but not limited to: ventilator dependence, cardiopulmonary disease, uncontrollable autonomic dysreflexia or orthostatic hypotension, or active urinary tract infections).
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 |
|---|---|---|
| Epidural Spinal Stimulation (ESS)An implanted paddle array delivers electrical stimulation near the spinal cord in the neck. Settings are adjusted to each participant's tolerance and arm and hand movement goals. Only trained study staff operate the stimulation controller. For participants receiving a permanent implant, home stimulation programs are established and refined before study completion. | Device | Epidural Spinal Stimulation (ESS) |
| Upper extremity rehabilitationParticipants complete arm and hand rehabilitation paired with cervical epidural spinal stimulation to work toward their movement goals. | Behavioural | Epidural Spinal Stimulation (ESS) |
Primary outcome
Primary Objective
Time frame: Safety: each visit from consent through last visit at week 17, for a total of 17 weeks; then re-assessed monthly after study completion for a period of 12 months. Other: before and after temporary and permanent phases, within 17 weeks of study duration.
Primary objectives are to evaluate safety and to quantify the neurophysiological and functional effects of ESS in individuals with SCI. Safety endpoints: Adverse events throughout the study; wound/skin condition; vital signs; pain and spasticity assessments. Neurophysiological and functional endpoints: electrophysiological assessments; MRI; functional assessments measuring 3D kinematics to access major joint and body segment assessments; spinal signals.
2 secondary outcomes
Secondary Objective
Time frame: Before and after temporary and permanent phases, within 17 weeks of study duration
Tertiary/Exploratory
Time frame: Up to 52 weeks after study ends
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 26 Oct 2026.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data from this study with other researchers.
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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.
Dimitry Sayenko, MD, PhD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural Spinal Stimulation (ESS) and Upper extremity rehabilitation in people with Spinal Cord Injuries and Cervical Spinal Cord Injury, run by The Methodist Hospital Research Institute at 1 site 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 14 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 Dimitry Sayenko (585-507-1706, sayenkolab@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: Safety: each visit from consent through last visit at week 17, for a total of 17 weeks; then re-assessed monthly after study completion for a period of 12 months. Other: before and after temporary and permanent phases, within 17 weeks of study duration.). 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 26 Oct 2026.