Your session is about to expire
← Back to Search
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 belowSelect...
I am between 21 and 70 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am mentally capable of understanding and signing a consent form.
Select...
I do not have any serious illness or cognitive issues that would prevent me from participating in the study.
Select...
I am taking medication for blood clots, muscle spasms, or seizures during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7, 15, 21, 29 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7, 15, 21, 29 days
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 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a stroke over 6 months ago that affected my arm's movement.I am mentally capable of understanding and signing a consent form.I am between 21 and 70 years old.I do not have any serious illness or cognitive issues that would prevent me from participating in the study.I am taking medication for blood clots, muscle spasms, or seizures during the study.You have a strong fear of being in small or enclosed spaces.My joint stiffness is too severe to do study activities.Your Fugl-Meyer scale score is not between 7 and 50.
Research Study Groups:
This trial has the following groups:- Group 1: Epidural electrical stimulation of the cervical spinal cord
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.