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COMPLETEDNA

Neuromotor Prosthetic to Treat Stroke-Related Paresis

NCT03913286•Thomas Jefferson University

Summary

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

Detailed Description

Microelectrode arrays implanted into the brain will decode signals to drive motors on the powered brace worn on the arm so that the patient can "power steer" his or her own arm. The ultimate goal is to create a fully implantable medical device that will restore movement in all parts of the body affected by a stroke. Independent movement will have functional benefits (e.g., being able to lift a fork to eat) and health benefits (e.g., decreasing the frequency of skin infections and preventing the formation of painful joint contractures).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Must be 18 years or older.
•Clinical diagnosis of stroke (hemorrhagic or ischemic, cortical or subcortical), confirmed by brain computer tomography or magnetic resonance imaging, that occurred six or more months prior to enrollment
•Must have arm weakness due to stroke.
•Participant is willing to comply with all follow-up evaluations at the specified times.
•Participant is able to provide informed consent prior to enrollment in the study.
•The participant is fluent in English.
•\> 24 on the Mini Mental Status Examination
•Medically stable.
•Passive flexion of shoulder in weakened upper extremity with range of \> 30 degrees or more
•Passive abduction of shoulder in weakened upper extremity with range of \> 20 degrees or more
+11 more criteria

Exclusion Criteria

•No medical condition requiring active anti-coagulation with a medication such as heparin, warfarin or rivaroxaban (note that anti-platelet agents such as aspirin or clopidogrel are acceptable)
•No active wound healing or skin breakdown issues.
•No history of poorly controlled autonomic dysreflexia.
•Visual impairment such that extended viewing of a computer monitor would be challenging even with ordinary corrective lenses
•Chronic oral or intravenous steroids or immunosuppressive therapy
•A score of 23 or lower on Folstein's Mini-Mental Status Examination
•Orthopedic conditions of either arm that would affect performance on study
•Untreated psychiatric disturbances that would affect motivation and trial participation
•Medical contraindications for general anesthesia, craniotomy, or surgery.
•Diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months.
+22 more criteria

Locations (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

May 1, 2019

Primary Completion Date

December 1, 2023

Completion Date

July 1, 2024

Last Updated

April 16, 2025

Enrollment

ACTUAL participants

Conditions

Stroke, ComplicationStrokeStroke SequelaeHemiparesisArm Paralysis

Interventions

Cortimo

DEVICE

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RECRUITINGPHASE1

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RECRUITINGNA

Cerebellar Stimulation for Aphasia Rehabilitation

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Neuromotor Prosthetic to Treat Stroke-Related Paresis

Inclusion Criteria

Exclusion Criteria

Effects of Circuit Training Combining Different Types of Distal Robot-assisted and Task-oriented Therapy on Motor Control, Motor and Daily Functions, and Quality of Life After Stroke

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants

Cerebellar Stimulation for Aphasia Rehabilitation

Rapid Evacuation and Access of Cerebral Hemorrhage Trial

Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

The CONFORM Pivotal Trial