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Neurostimulation Device

Spinal Cord Stimulation for Stroke Recovery

N/A
Waitlist Available
Led By Marco Capogrosso, PhD
Research Sponsored by Lee Fisher, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be between the ages of 21 and 70 years old.
Be older than 18 years old
Must not have
Evaluation to sign consent form score <12.
Serious disease or disorder (ex. neurological condition other than stroke, cancer, severe cardiac or respiratory disease, renal failure, etc.) or cognitive impairments that could affect the ability to participate in study activities.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7, 15, 21, 29 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether electrical stimulation of the spinal cord can help people with paralysis in one arm recover movement. A device is implanted to deliver the stimulation, and then removed after a month.

Who is the study for?
This trial is for adults aged 21-70 who've had a stroke at least 6 months ago, resulting in arm weakness but not complete paralysis. They should be able to participate actively and not have severe diseases, cognitive issues, or be pregnant. They can't take certain medications or have implants that could interfere with the study.
What is being tested?
Researchers are testing if electrical stimulation of the spinal cord can help activate arm and hand muscles in stroke survivors with hemiplegia. Participants will get a temporary implant to deliver this stimulation and see if it improves their ability to move their limbs.
What are the potential side effects?
Potential side effects may include discomfort from the surgical procedure for implant placement and removal, possible skin irritation from the device, muscle pain due to electrical stimulation, and risks associated with any surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am mentally capable of understanding and signing a consent form.
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I do not have any serious illness or cognitive issues that would prevent me from participating in the study.
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I am taking medication for blood clots, muscle spasms, or seizures during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7, 15, 21, 29 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7, 15, 21, 29 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events
Discomfort and Pain
Secondary study objectives
Cortico-spinal Tract Integrity
Dexterity / Function: Action Research Arm Test
Joint Velocity
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Epidural electrical stimulation of the cervical spinal cordExperimental Treatment1 Intervention
Individuals with prior subcortical stroke and hemiparesis of the upper extremity.

Find a Location

Who is running the clinical trial?

Lee Fisher, PhDLead Sponsor
3 Previous Clinical Trials
50 Total Patients Enrolled
Marco CapogrossoLead Sponsor
2 Previous Clinical Trials
23 Total Patients Enrolled
Marco Capogrosso, PhDPrincipal Investigator - University of Pittsburgh
University of Pittsburgh

Media Library

Epidural electrical stimulation (EES) of the cervical spinal cord (Neurostimulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT04512690 — N/A
Stroke Research Study Groups: Epidural electrical stimulation of the cervical spinal cord
Stroke Clinical Trial 2023: Epidural electrical stimulation (EES) of the cervical spinal cord Highlights & Side Effects. Trial Name: NCT04512690 — N/A
Epidural electrical stimulation (EES) of the cervical spinal cord (Neurostimulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04512690 — N/A
~3 spots leftby Sep 2025
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