Is NCT07153536 recruiting in Pittsburgh, PA?

Yes, NCT07153536 is currently recruiting participants at its Pittsburgh, PA location. This stroke clinical trial is actively enrolling qualified participants.

How do I join the stroke clinical trial in Pittsburgh?

To join this clinical trial in Pittsburgh, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Pittsburgh clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Stroke Clinical Trial in Pittsburgh, PA

About This Stroke Study in Pittsburgh

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.

Sponsor: Marco Capogrosso

Who Can Participate

Inclusion Criteria

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

Exclusion Criteria

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 Exclusion Criteria:

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

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Pittsburgh?

Yes, this clinical trial (NCT07153536) has an active research site in Pittsburgh, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Stroke Treatment Options in Pittsburgh, PA

If you're searching for stroke treatment options in Pittsburgh, PA, this clinical trial (NCT07153536) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Pittsburgh research site is actively enrolling participants for this clinical trial. You'll receive care from experienced stroke specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all stroke clinical trials near you to find additional studies recruiting in your area.

Stroke Clinical Trial in Pittsburgh, PA

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