StrokeNCT07153536
Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis
A study testing Spinal Cord Stimulator (Medtronic Inceptiv™ System) and Physical Therapy in people with Stroke and Spinal Cord Injuries and Disorders, run by Marco Capogrosso at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Stroke, Spinal Cord Injuries and Disorders, Hemiparesis After Stroke
- What is being tested?
- Spinal Cord Stimulator (Medtronic Inceptiv™ System) and Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- The ability to communicate, understand, give appropriate consent and follow two-step commands
Who cannot join
- 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
- Female participants of child-bearing age who are pregnant or breastfeeding during the study
- Participants that cannot suspend their antiplatelets and/or anticoagulant therapy for two weeks around the time of surgery
Show all 13Show fewer
- Existence of any implanted medical device that is not MRI safe and/or any active medical devices even if it is MRI safe
- Implanted spinal fusion and stabilization devices such as plates and rods between the C2 and T3 spinal vertebra
- 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
- Severe claustrophobia that prevents execution of the required MRI imaging sessions
- Taking anti-spasticity or anti-epileptic medications
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Amy Boos, MS, 412-648-4179, amy.boos@pitt.edu
Cierra Clark, MS, 240-441-4216, cic27@pitt.edu
About this study
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.
Read the 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.
- Being tested
- Spinal Cord Stimulator (Medtronic Inceptiv™ System), Physical Therapy
- Keywords
- spinal cord stimulation
- Medical subject headings
- Stroke, Spinal Cord Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 TherapyOther
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 group | Role | What they receive |
|---|---|---|
| Physical Therapy Alone, then Combined with Spinal Cord Stimulation | Experimental | 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. Receives: Device: Spinal Cord Stimulator (Medtronic Inceptiv™ System); Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Severity of Adverse Events
Success Criteria: no serious adverse events related to the stimulation or intolerable. adverse events reported
Measured: From enrollment to the end of treatment at 49 weeks
Secondary outcomes (6)
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 .
Measured: Post implant to the end of Phase 2 (11 weeks)
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.
Measured: Baseline to the end of Phase 2 (19 weeks)
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.
Measured: Phase 2 (7 weeks)
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.
Measured: Baseline to the end of Phase 2 (19 weeks)
Strength - Phase 2
The investigators will measure changes in isometric torque produced during maximal voluntary contractions across shoulder, elbow and grip strength with SCS ON and SCS OFF. Success criteria: 75% of the participants have significantly higher maximal torques (or forces) with SCS ON compared to SCS OFF in at least 1 movement of at least 1 joint. (e.g. elbow extension). This will confirm that SCS can immediately improve strength.
Measured: Phase 2 (7 weeks)
Motor Control - Phase 2 and 3
The investigators will perform FM testing within a 2-day period with SCS OFF and SCS ON. The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. The upper extremity motor function score ranges from 0 to 66 points, with a higher score indicating a better outcome. Success criteria: 75% of the participants have higher FM scores with SCS ON compared to SCS OFF of at least 3 points.
Measured: Phase 2 through Phase 3 (31 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start6 Jan 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, interventional, open-label, non-randomized, single-arm feasibility study to obtain initial evidence of safety and efficacy of using spinal cord stimulation (SCS) in combination with physical therapy.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marco Capogrosso
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor-investigator, Marco Capogrosso, University of Pittsburgh
- Investigators
- George Wittenberg, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153536
- Sponsor's protocol ID
- STUDY25060125
- Other IDs
- 1UG3NS123135-01A1
- Status last verified
- Jan 2026
- First submitted
- 20 Aug 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification, may be shared with other researchers for the purpose of data analysis and collaboration.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis
- ClinicalTrials.gov ID
- NCT07153536
- Acronym / sponsor ID
- STUDY25060125
- Keywords
- spinal cord stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Marco CapogrossoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, interventional, open-label, non-randomized, single-arm feasibility study to obtain initial evidence of safety and efficacy of using spinal cord stimulation (SCS) in combination with physical therapy.
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy Alone, then Combined with Spinal Cord Stimulation | Experimental | Device: Spinal Cord Stimulator (Medtronic Inceptiv™ System), Other: Physical TherapyTwo 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. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
- The ability to communicate, understand, give appropriate consent and follow two-step commands
Key exclusion criteria (13 listed)
- 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
- Female participants of child-bearing age who are pregnant or breastfeeding during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Physical Therapy Alone, then Combined with Spinal Cord Stimulation |
| Physical TherapyThe 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. | Other | Physical Therapy Alone, then Combined with Spinal Cord Stimulation |
Primary outcome
Number and Severity of Adverse Events
Time frame: From enrollment to the end of treatment at 49 weeks
Success Criteria: no serious adverse events related to the stimulation or intolerable. adverse events reported
6 secondary outcomes
Motor Impairment - Post Implant to end of Phase 2
Time frame: Post implant to the end of Phase 2 (11 weeks)
Motor Impairment - Absolute Change
Time frame: Baseline to the end of Phase 2 (19 weeks)
Spasticity - Phase 2
Time frame: Phase 2 (7 weeks)
Spasticity - Absolute Change
Time frame: Baseline to the end of Phase 2 (19 weeks)
Strength - Phase 2
Time frame: Phase 2 (7 weeks)
Motor Control - Phase 2 and 3
Time frame: Phase 2 through Phase 3 (31 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification, may be shared with other researchers for the purpose of data analysis and collaboration.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
George Wittenberg, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulator (Medtronic Inceptiv™ System) and Physical Therapy in people with Stroke and Spinal Cord Injuries and Disorders, run by Marco Capogrosso at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Boos, MS (412-648-4179, amy.boos@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Severity of Adverse Events (time frame: From enrollment to the end of treatment at 49 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.