Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis
Marco Capogrosso
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.
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 up…
Eligibility
- Age range
- 22–70 years
- Sex
- All
- Healthy volunteers
- No
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. Presenc…
Interventions
- DeviceSpinal 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.
- OtherPhysical 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.
Location
- University of PittsburghPittsburgh, Pennsylvania