Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-70
SponsorMarco Capogrosso
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.)
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Spinal Cord Stimulator (Medtronic Inceptiv™ System)
DeviceThe 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 interventionThe 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Physical Therapy Alone, then Combined with Spinal Cord StimulationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number and Severity of Adverse Events
Success Criteria: no serious adverse events related to the stimulation or intolerable. adverse events reported
Time frame
From enrollment to the end of treatment at 49 weeksSecondary outcomes
1
Motor Impairment - Post Implant to end of Phase 2
The investigators will measure the change in Fugl Meyer (FM) score from post-implant to the end of Phase 2 with SCS ON. The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The upper extremity motor function score ranges from 0 to 66 points. Success criteria: mean change FM across Phase 2 is greater than zero, indicating an additional therapeutic benefit of SCS beyond physical training executed in Phase 1 .
Time frame
Post implant to the end of Phase 2 (11 weeks)2
Motor Impairment - Absolute Change
The investigators will measure the change in Fugl Meyer (FM) score from the baseline to the end of Phase 2 with SCS OFF. The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The upper extremity motor function score ranges from 0 to 66 points. Success criteria: mean change FM across the study period is greater than 5, indicating the average improvement surpasses the minimal clinically meaningful threshold.
Time frame
Baseline to the end of Phase 2 (19 weeks)3
Spasticity - Phase 2
The investigators will quantify spasticity scores using the Modified Ashworth Scale (MAS) which is an assessment that is used to measure the increase in muscle tone. MAS assigns a grade of spasticity from a 0-4 ordinal scale. The grade is assigned by moving a joint/muscle through a high velocity quick stretch. The investigators will measure the change in MAS score across phase 2. The test is executed with SCS OFF. Success criteria: mean change MAS across Phase 2 is greater than 0. This would show that SCS is able to reduce spasticity beyond the Phase 1 physical training.
Time frame
Phase 2 (7 weeks)4
Spasticity - Absolute Change
The investigators will quantify spasticity scores using the Modified Ashworth Scale (MAS) which is an assessment that is used to measure the increase in muscle tone. MAS assigns a grade of spasticity from a 0-4 ordinal scale. The grade is assigned by moving a joint/muscle through a high velocity quick stretch. The investigators will measure the change in MAS score from the baseline to the end of Phase 2. The test is executed with SCS OFF. Success criteria: mean change MAS across the study is greater or equal than 2 points, indicating that average reduction surpasses the minimal clinically meaningful threshold.
Time frame
Baseline to the end of Phase 2 (19 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Marco Capogrosso
Lead sponsor
University of Pittsburgh
Sponsor institution
National Institutes of Health (NIH)
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov