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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Marco Capogrosso
Study ID
NCT07153536
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
22 Years - 70 Years
Healthy Volunteers
Not accepted

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 — 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.

Study Details

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.

Key Dates

Start date
Jan 6, 2026
Status verified
Jan 2026
Primary completion
Mar 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15213
Amy Boos, MS
[email protected]
412-648-4179
Cierra Clark, MS
[email protected]
240-441-4216

Find similar trials in Pittsburgh, PA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
University of Pittsburgh· Pittsburgh, PA

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