Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis

NCT07153536 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY250601251UG3NS123135-01A1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study plans to use systems that have been developed by Medtronic to investigate the use of cervical spinal cord stimulation to treat adults with upper limb hemiparesis resulting from a stroke. The spinal cord stimulation (SCS) will be combined with physical training to improve arm and hand motor control. The study is divided into three phases. In the first phase, after baseline assessments, participants will undergo a Physical Training Protocol (PTP) for 6 weeks including 3 sessions of 90 mins/session per week. After receiving the Medtronic implantable system, in Phase 2, they will then repeat the same PTP program in combination with spinal cord stimulation during the entirety of each of the rehabilitation sessions. Finally, in Phase 3, participants will go home, will not be able to use the stimulation at home but will participate in monthly assessments in the laboratory in which the functionality of the Medtronic system and their motor performances will be assessed for up to 6 months.

Conditions

Stroke; Spinal Cord Injuries and Disorders; Hemiparesis After Stroke

Keywords

spinal cord stimulation

Outcome Measures

Primary Outcomes (1)

• Number and Severity of Adverse Events

  Success Criteria: no serious adverse events related to the stimulation or intolerable. adverse events reported

  From enrollment to the end of treatment at 49 weeks

Secondary Outcomes (6)

• Motor Impairment - Post Implant to end of Phase 2

  Post implant to the end of Phase 2 (11 weeks)

• Motor Impairment - Absolute Change

  Baseline to the end of Phase 2 (19 weeks)

• Spasticity - Phase 2

  Phase 2 (7 weeks)

• Spasticity - Absolute Change

  Baseline to the end of Phase 2 (19 weeks)

• Strength - Phase 2

  Phase 2 (7 weeks)

Study Arms (1)

Physical Therapy Alone, then Combined with Spinal Cord Stimulation

EXPERIMENTAL

Two percutaneous leads will be implanted unilaterally on the affected side in the epidural space of the C3-T1 vertebrae (Medtronic Vectris™ SureScan™ 1x8). The leads will be connected to an external stimulator (Medtronic Inceptiv™ spinal cord neurostimulation system) during research activities.

Device: Spinal Cord Stimulator (Medtronic Inceptiv™ System); Other: Physical Therapy

Interventions

Spinal Cord Stimulator (Medtronic Inceptiv™ System) DEVICE

The Medtronic Inceptiv™ spinal cord neurostimulation system is a rechargeable implantable pulse generator (IPG) designed to deliver electrical pulses to the spinal cord via implanted leads. The system is intended for use in patients with chronic pain.

Physical Therapy Alone, then Combined with Spinal Cord Stimulation

Physical Therapy OTHER

The physical therapy intervention consists of two components: the Mind-Pod Dolphin system (targeting arm function) and the Hummingbird Hunt system (targeting hand function). Both systems use interactive gaming software that enables participants to engage in remote, game-based therapy. Each system offers multiple difficulty levels, allowing participants to progress as their skills improve.

Physical Therapy Alone, then Combined with Spinal Cord Stimulation

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 22 to 70 years old
• Upper extremity motor score higher than 20 and lower than or equal to 45 on the Fugl-Meyer Assessment (FMA) scale
• FMA upper extremity sensory score higher than 6 points (out of 12 points)
• The ability to communicate, understand, give appropriate consent and follow two-step commands

You may not qualify if:

• Presence of any serious disease or disorder (ex. Neurological conditions other than stroke, cancer, severe cardiac or respiratory disease, renal failure, etc.) that could affect their ability to participate in this study
• Considered to be at high-risk of recurrent stroke as evident from their medical history or upon judgment of the study physician
• Presence of post-stroke central pain, other forms of pain or other constraints such as joint contractures in the paretic arm that are serious enough to prevent or affect the correct execution of the physical training protocol as judged by the study therapist
• A score on the Short Blessed Test assessment scale lower than 9
• Female participants of child-bearing age who are pregnant or breastfeeding during the study
• Participants that cannot suspend their antiplatelets and/or anticoagulant therapy for two weeks around the time of surgery
• Existence of any implanted medical device that is not MRI safe and/or any active medical devices even if it is MRI safe
• Implanted spinal fusion and stabilization devices such as plates and rods between the C2 and T3 spinal vertebra
• Obstructed or restricted epidural spinal canal to the point of hindering or increasing the risk of implant of the spinal leads as judged by the study surgeon upon screening imaging
• Severe claustrophobia that prevents execution of the required MRI imaging sessions
• Taking anti-spasticity or anti-epileptic medications
• T-score higher than 63 on the 18-question Brief Symptoms Inventory (BSI-18) who have undergone discussions with and been deemed unsuitable by the Principal Investigator and a study physician
• Potential participants who may be excluded on initial screening may discuss possible medication changes with their physician.

Sponsors & Collaborators

• Marco Capogrosso: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Spinal Cord Injuries; Disease

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• George Wittenberg, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Boos, MS

CONTACT

412-648-4179; amy.boos@pitt.edu

Cierra Clark, MS

CONTACT

240-441-4216; cic27@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single-center, interventional, open-label, non-randomized, single-arm feasibility study to obtain initial evidence of safety and efficacy of using spinal cord stimulation (SCS) in combination with physical therapy.

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 4, 2025
• Study Start: January 6, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available at the end of the trial upon publication of the first manuscript. Estimation is 2 years from enrollment of first participant.
• Access Criteria: Data must be directly requested to the PI and will be shared upon completion of necessary data sharing agreement to protect confidential patient information.

Locations

US (1)