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Neuromotor Prosthetic

Neuromotor Prosthetic for Paresis (Cortimo Trial)

N/A
Waitlist Available
Led By Mijail Serruya, MD, PhD
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Passive abduction of shoulder in weakened upper extremity with range of > 20 degrees or more
Passive flexion of shoulder in weakened upper extremity with range of > 30 degrees or more
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

Cortimo Trial Summary

This trial is testing a new medical device to help people with chronic stroke regain movement in their arms.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the device, skin irritation at surgical sites or where the device attaches, muscle fatigue from using the prosthetic limb during rehabilitation exercises and possible psychological impacts of adapting to a new assistive technology.

Cortimo Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can lift my weak arm sideways more than 20 degrees.
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I can lift my weak arm at the shoulder more than 30 degrees.
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I am 18 years old or older.
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I have arm weakness because of a stroke.

Cortimo Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline ADL, Hand and Recovery Scales within Stroke Impact Scale, at 4 months
Change from Baseline Action Research Arm Test (ARAT) score at 4 months
Change from Baseline Fugl-Meyer Motor Impairment Score at 4 months
+1 more
Secondary outcome measures
Change from Baseline Braden skin health score at 4 months

Cortimo Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
The participant will be implanted with the Blackrock Microsystems MultiPort system.

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
444 Previous Clinical Trials
145,623 Total Patients Enrolled
3 Trials studying Stroke
400 Patients Enrolled for Stroke
Mijail Serruya, MD, PhDPrincipal InvestigatorDr.
2 Previous Clinical Trials
1,020 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for this clinical research?

"As per the clinicaltrials.gov website, this medical trial is no longer accepting patients and has since concluded its recruitment phase that began on May 1st 2019 before being last updated March 2nd 2022. Although not actively looking for participants, there are 1148 other trials in progress which may be of interest to potential volunteers."

Answered by AI

Who else is applying?

What site did they apply to?
Thomas Jefferson University
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Still hopeful for use of hand and arm in adl and quality of life and appearance.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Neuromotor Prosthetic to Treat Stroke-Related Paresis
2019. "Neuromotor Prosthetic to Treat Stroke-Related Paresis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03913286.
All > Stroke
~0 spots leftby Apr 2025
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