Spinal Cord Stimulation + Physical Therapy for Stroke-related Hemiparesis

Overseen By Cierra Clark, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Marco Capogrosso

Must not be taking: Antiplatelets, Anticoagulants, Anti-spasticity, Anti-epileptic

Disqualifiers: Neurological conditions, Cancer, Severe cardiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals who struggle with arm and hand movement after a stroke. It combines spinal cord stimulation, which sends electrical pulses to the spine, with physical therapy to assess improvements in motor control. Participants will first undergo physical therapy alone, then repeat it with spinal stimulation using the Spinal Cord Stimulator (Medtronic Inceptiv™ System). This trial suits those who experienced a stroke over six months ago and continue to have difficulty using their arm and hand. As an unphased trial, it offers a unique opportunity to explore innovative treatments that could enhance recovery and improve quality of life.

Do I need to stop my current medications for the trial?

Yes, you will need to stop taking antiplatelets and/or anticoagulant therapy for two weeks around the time of surgery. Additionally, you cannot participate if you are taking anti-spasticity or anti-epileptic medications.

What prior data suggests that this spinal cord stimulation system is safe for treating stroke-related hemiparesis?

Research shows that the Medtronic Inceptiv™ spinal cord stimulator has been safely used for conditions like chronic pain, indicating it is generally well-tolerated. This trial examines its safety for stroke patients with arm weakness.

Specific side effects for stroke patients remain unknown, but the device's approval for other uses suggests it is usually safe. The trial also evaluates its safety when combined with physical therapy. So far, similar situations have revealed no major safety issues. Participants should consult the trial team or their doctor with any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about spinal cord stimulation for stroke-related hemiparesis because it offers a novel way to enhance physical therapy outcomes. Unlike standard treatments such as physical therapy alone, this approach uses the Medtronic Inceptiv™ System to send electrical impulses directly to the spinal cord. These impulses may help improve motor function by engaging the neural pathways more effectively. By combining spinal cord stimulation with physical therapy, there is potential for more significant recovery in muscle strength and movement, which is a promising advancement for stroke survivors facing hemiparesis.

What evidence suggests that spinal cord stimulation combined with physical therapy is effective for stroke-related hemiparesis?

This trial will evaluate the effects of combining spinal cord stimulation with physical therapy for stroke-related hemiparesis. Studies have shown that spinal cord stimulation can improve movement in individuals with stroke-induced weakness on one side of the body. Research indicates that this combination can enhance arm and hand mobility. Initial findings suggest that patients experienced better muscle control after this treatment. This method, particularly with the Medtronic Inceptiv™ system, has also shown promise in treating other conditions, such as chronic pain, by significantly reducing symptoms. While specific data on stroke is still being gathered, stimulating the spinal cord to boost nerve signals shows potential for improving movement in stroke survivors. ^{1 2 6 7 8}

Who Is on the Research Team?

George Wittenberg, MD, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults with upper limb hemiparesis due to a stroke, who can undergo physical therapy and spinal cord stimulation. Participants should not have liver disease or other conditions that could interfere with the study.

Inclusion Criteria

FMA upper extremity sensory score higher than 6 points (out of 12 points)

I had a stroke over 6 months ago that affected my arm and hand movement.

I am between 22 and 70 years old.

Exclusion Criteria

Considered to be at high-risk of recurrent stroke as evident from their medical history or upon judgment of the study physician

A score on the Short Blessed Test assessment scale higher than 9

Existence of any implanted medical device that is not MRI safe and/or any active medical devices even if it is MRI safe

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Physical Training Protocol (PTP)

Participants undergo a Physical Training Protocol for 6 weeks including 3 sessions of 90 mins/session per week

6 weeks

Treatment with Spinal Cord Stimulation

Participants receive spinal cord stimulation combined with the Physical Training Protocol

11 weeks

Follow-up

Participants are monitored monthly in the laboratory for functionality of the SR-SCS system and motor performance

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Physical Therapy
• Spinal Cord Stimulator (Medtronic Inceptiv™ System)

Trial Overview The trial tests if using Medtronic's Spinal Cord Stimulator along with physical therapy improves arm and hand control in stroke survivors. It includes initial training, then sessions with the stimulator, followed by home assessments without active stimulation.

How Is the Trial Designed?

Group I: Physical Therapy Alone, then Combined with Spinal Cord Stimulation Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Marco Capogrosso

Lead Sponsor

Trials

3

Recruited

40+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07153536

Spinal Cord Stimulation Combined With Physical Therapy ... It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in ...

2. news.medtronic.com news.medtronic.com/New-12-month-clinical-data-highlights-significant-and-sustained-benefits-of-the-Inceptiv-TM-closed-loop-spinal-cord-stimulation-system

New 12-month clinical data highlights significant and ... Study shows 67% mean reduction in Low-back Visual Analog Scale (VAS) pain score at 12 months; 87% of subjects had meaningful improvements in ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P840001S469B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The safety and effectiveness of the Medtronic implantable neurostimulation system to treat PDN was based on clinical safety outcome data from the Medtronic ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40799959/

SPINAL CORD STIMULATION IMPROVES MOTOR ... - PubMed Here, we report the final outcomes of a pilot clinical trial testing preliminary efficacy and safety of cervical epidural spinal cord ...

5. medrxiv.org medrxiv.org/content/10.1101/2025.08.01.25332445v1.full-text

SPINAL CORD STIMULATION IMPROVES MOTOR ... Here, we report the final outcomes of a pilot clinical trial testing preliminary efficacy and safety of cervical epidural spinal cord ...

6. medtronic.com medtronic.com/en-us/healthcare-professionals/products/neurological/spinal-cord-stimulation/neurostimulation-systems/inceptiv-neurostimulation-system.html

Inceptiv™ Neurostimulation System Inceptiv™spinal cord stimulator (SCS) is a rechargeable neurostimulator that adjusts in real-time with closed-loop technology to help treat chronic pain.

7. withpower.com withpower.com/trial/phase-stroke-8-2025-9705f

Spinal Cord Stimulation + Physical Therapy for Stroke ... This N/A medical study run by Marco Capogrosso is evaluating whether Spinal Cord Stimulator (Medtronic Inceptiv™ System) will have tolerable side effects ...

8. medtronic.com medtronic.com/me-en/healthcare-professionals/products/neurological/spinal-cord-stimulation-systems/inceptiv-neurostimulator.html

Inceptiv™ neurostimulator provides consistent therapy while patients perform a full range of daily activities. Inceptiv™ actively listens*5 to the spinal cord and responds instantly.