Augmenting Rehabilitation Outcomes and Functional Neuroplasticity Using Epidural Stimulation of Cervical Spinal Cord

NCT06225245 | Recruiting DMC FDA Device

• 1 other identifier: PRO00037827
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to investigate the effects of cervical epidural spinal stimulation with upper extremity training. This is an investigational study. The device used for epidural spinal stimulation (ESS) to deliver spinal stimulation is called the CoverEdgeX 32 Surgical Lead system. This device is approved by the Food and Drug Administration (FDA) for the treatment of severe pain and to manage chronic pain when other treatments have not been effective. In this study, the device is considered an investigational device because it is not approved for use in the treatment of spinal cord injury

Conditions

Spinal Cord Injuries; Cervical Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• Assessment of Upper Limb Muscle Response

  Neuromotor outcomes in the upper limb muscles will be assessed, specifically targeting the upper arm, forearm, wrist, and fine motor movements. Measurements will be conducted during voluntary effort without spinal stimulation, as well as in the presence of Epidural Spinal Stimulation (ESS). The force output will be quantified in newtons (N), while the magnitude of EMG signals will be measured and expressed in millivolts (mV).

  Baseline (Week 4), Post Intervention (Week 7), Follow up (Week 10), Follow up (Week 13)

Secondary Outcomes (2)

• Assessment of Neurological Status

  Baseline (Week 1), Post Intervention (Week 8), Follow up (Week 16)

• Assessment of Independence

  Baseline (Week 1), Post Intervention (Week 8), Follow up (Week 16)

Study Arms (1)

Epidural Spinal Stimulation (ESS)

EXPERIMENTAL

ESS will be delivered using The CoverEdgeX 32 Surgical Lead at frequencies of 0.2 to 60 Hz with intensity up to 10 mA, adjusted to induce motor threshold responses in the target muscle for the above motor task (e.g., biceps brachii for elbow flexion) \[31-33\]. The ESS controller will only be operated by trained study team members. Therefore, stimulation will only be delivered during study visits. Stimulation will be administered for a maximum duration of 1 hour total per visit, varying according to the individual's tolerance and fatigue levels, with 5 - 10 minutes breaks interspersed between intervals of stimulation.

Device: Epidural Spinal Stimulation (ESS)

Interventions

Epidural Spinal Stimulation (ESS) DEVICE

ESS will be delivered using The CoverEdgeX 32 Surgical Lead at frequencies of 0.2 to 60 Hz with intensity up to 10 mA, adjusted to induce motor threshold responses in the target muscle for the above motor task (e.g., biceps brachii for elbow flexion) \[31-33\]. The ESS controller will only be operated by trained study team members. Therefore, stimulation will only be delivered during study visits. Stimulation will be administered for a maximum duration of 1 hour total per visit, varying according to the individual's tolerance and fatigue levels, with 5 - 10 minutes breaks interspersed between intervals of stimulation.

Epidural Spinal Stimulation (ESS)

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants must provide a signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female aged 22 - 65 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 including:
• greater than 90 degrees of shoulder flexion and 20 degrees of shoulder extension;
• greater than 120 degrees of elbow flexion and reach elbow extension of approximately 150 degrees;
• neutral wrist position reaching a minimum of 70 degrees of movement (between flexion and extension;
• ability to passively flex and extend fingers.
• 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.
• Non-progressive spinal cord injury.
• Chronic SCI with neurologic level of injury as defined by ISNCSCI AIS A, B, or C.
• Neurological level of injury above T2.
• Eligible for fMRI per safety questionnaire.

You may not qualify if:

• 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, active urinary tract infections, pregnant or nursing).
• Intrathecal baclofen pump therapy for spasticity.
• Must not have received Botox injections to primary lower 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 muscular tears in the upper or lower extremities, pain in weight bearing positions for upper and lower extremities).
• Clinically significant depression, psychiatric disorders, or ongoing drug abuse.
• 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.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

The Methodist Hospital Research Institute

Houston, Texas, 77030, 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

• Dimitry Sayenko, MD, PhD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Dinh

CONTACT

346-238-4654; jtdinh@houstonmethodist.org

Rachel Markley

CONTACT

713-441-3770; rmarkley@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 25, 2024
• Study Start: August 6, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-03

Locations

US (1)