Recruiting

SCS with Physical Training

Sponsor:

Marco Capogrosso

Code:

NCT07153536

Conditions

Stroke

Spinal Cord Injuries and Disorders

Hemiparesis After Stroke

Eligibility Criteria

Sex: All

Age: 22 - 70

Healthy Volunteers: Not accepted

Interventions

Spinal Cord Stimulator (Medtronic Inceptiv™ System)

Physical Therapy

Study Details

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

Study ID

NCT07153536

Start date

Jan 6, 2026

Status verified date

Jan, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Experienced an ischemic or hemorrhagic stroke that resulted in arm and hand hemiparesis more than 6 months prior to the time of enrollment (Prior strokes that did not cause upper extremity motor deficits are not exclusionary.)
2. Age 22 to 70 years old
3. Upper extremity motor score higher than 20 and lower than or equal to 45 on the Fugl-Meyer Assessment (FMA) scale
4. FMA upper extremity sensory score higher than 6 points (out of 12 points)
5. The ability to communicate, understand, give appropriate consent and follow two-step commands

Exclusion Criteria:

1. 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
2. Considered to be at high-risk of recurrent stroke as evident from their medical history or upon judgment of the study physician
3. 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
4. A score on the Short Blessed Test assessment scale lower than 9
5. Female participants of child-bearing age who are pregnant or breastfeeding during the study
6. Participants that cannot suspend their antiplatelets and/or anticoagulant therapy for two weeks around the time of surgery
7. Existence of any implanted medical device that is not MRI safe and/or any active medical devices even if it is MRI safe
8. Implanted spinal fusion and stabilization devices such as plates and rods between the C2 and T3 spinal vertebra
9. 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
10. Severe claustrophobia that prevents execution of the required MRI imaging sessions
11. Taking anti-spasticity or anti-epileptic medications
12. 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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Physical Therapy Alone, then Combined with Spinal Cord Stimulation

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.

Interventions

Spinal Cord Stimulator (Medtronic Inceptiv™ System)

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

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.

Primary outcome measure

  • Number and Severity of Adverse Events [ Time Frame: From enrollment to the end of treatment at 49 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

More Information

Sponsor

Marco Capogrosso

Last update posted

Jun 22, 2026

Last verified

Jan, 2026

Keywords

  • spinal cord stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Marco Capogrosso on 2026-06-22.