NCT07153536

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Marco Capogrosso · Academic / Other
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The main goal for this study is to evaluate safety of the Medtronic system in the stroke population. The second goal of this study is to assess and document the effects of SCS on motor control. More specifically, whether the combination of SCS and physical exercise (PTP+SCS) will improve motor control and reduce impairments, with the goal of optimizing inclusion criteria and outcome measures for future efficacy studies. To achieve this goal, we designed a study based on the rationale that the ramp up PTP phase 1 will bring people to a plateau motor impairment, in consequence any improvement upon this plateaued level should be due to the intervention.

Conditions

• Stroke
• Spinal Cord Injuries and Disorders
• Hemiparesis After Stroke

Interventions

Type	Name	Description
DEVICE	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.
OTHER	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.

Timeline

• Start date: 2026-01-06
• Primary completion: 2027-03-01
• Completion: 2028-01-01
• First posted: 2025-09-04
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study