Neuromotor Prosthetic for Paresis

(Cortimo Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Mijail Serruya, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Thomas Jefferson University

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of the research is to develop a new medical device prototype to restore functional movement of an arm made weak due to a chronic stroke

Research Team

Mijail Serruya, MD, PhD

Principal Investigator

Dr.

Eligibility Criteria

This trial is for English-speaking adults over 18 who've had a stroke at least six months ago, leading to arm weakness. They need a caregiver, must stay near the hospital for 90 days with the device implanted, and be willing to follow up. They can't join if they have severe medical conditions like heart issues or dementia, other implants, rely on ventilators, are pregnant without contraception use, or are in another study.

Inclusion Criteria

I can lift my weak arm sideways more than 20 degrees.

Participant is able to provide informed consent prior to enrollment in the study

The participant is fluent in English

Exclusion Criteria

You do not have a history of poorly controlled autonomic dysreflexia.

You have untreated mental health issues that would make it hard for you to stay motivated and take part in the trial.

I do not have any current wounds or skin problems that are healing.

Treatment Details

Interventions

• Cortimo (Neuromotor Prosthetic)

Trial Overview The trial is testing 'Cortimo', a new neuromotor prosthetic device designed to help restore arm movement in people with chronic stroke-induced paralysis. Participants will receive this prototype device and their ability to move their weakened arm will be evaluated.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

The participant will be implanted with the Blackrock Microsystems MultiPort system.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Dr. Eugene Kennedy

Thomas Jefferson University

Chief Medical Officer since 2020

MD

Dr. Joseph G. Cacchione

Thomas Jefferson University

Chief Executive Officer since 2022

MD, MBA