Neuromotor Prosthetic to Treat Stroke-Related Paresis

NCT03913286 | Completed DMC FDA Device

• 1 other identifier: 17D.459
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Stroke, Complication; Stroke; Stroke Sequelae; Hemiparesis; Arm Paralysis

Keywords

neuroprosthetic; neuroprosthesis; brain-computer; brain-machine; microelectrode; Utah array; orthosis; brain computer interface; assistive device; Neurorehabilitation; neurotechnology

Outcome Measures

Primary Outcomes (4)

• Change from Baseline Fugl-Meyer Motor Impairment Score at 4 months

  The Fugl-Meyer assessment (FMA) is a stroke specific index for estimating the performance of motor function. Total scores of FMA-Upper limb range from 0-66. From: Fugl-Meyer et al. The post-stroke hemiplegic patient: a method for evaluation of physical performance. Scand. J. Rehabil. Med., 1975.

  4 months

• Change from Baseline Action Research Arm Test (ARAT) score at 4 months

  The Action Research Arm Test (ARAT) measures specific changes in the arm function in people who sustained cerebral damage resulting in arm weakness. The ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch and gross movements. Each sub scale has items ordered according to ascending difficulty: 0- can not perform any part of the test, 1- performs the test partially, 2- completes the test, but takes abnormally long time, 3- performs the test normally. The sum of all subscales are added to compute the total score. The total score ranges between 0 to 57. The higher score is considered to be better outcome. From: Yozbatiran et al. A standardized approach to performing the action research arm test. Neurorehabil. Neural Repair, 2008.

  4 months

• Change from Baseline Motricity Index score at 4 months

  The Motricity Index measures strength in the arms and legs after stroke. The weighted score is based on the ordinal 6 point scale of Medical Research Council to measure maximal isometric muscle strength. From: Collin and Wade. Assessing motor impairment after stroke: A pilot reliability study. J. Neurol. Neurosurg. Psychiatry, 1990.

  4 months

• Change from Baseline ADL, Hand and Recovery Scales within Stroke Impact Scale, at 4 months

  The Stroke Impact Scales assess how having a stroke impacts a person's life. The scale has 8 subscales which ask questions regarding a person's physical limitations, memory and thinking, emotions and mood, ability to communicate, daily activities, mobility at home and in the community, use of hand most affected by stroke, and ability to participate in meaningful life activities. Each subscale item is rated on a scale from 5-1 (5= None of the time, 4=a little of the time, 3=Some of the time, 2=Most of the time, 1=All of the time). ADL = activities of daily living. From: Duncan et al. The Stroke Impact Scale Version 2.0 : Evaluation of Reliability, Validity, and Sensitivity to Change. Stroke, 1999.

  4 months

Secondary Outcomes (1)

• Change from Baseline Braden skin health score at 4 months

  4 months

Study Arms (1)

Intervention

EXPERIMENTAL

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

Device: Cortimo

Interventions

Cortimo DEVICE

The Cortimo comprises an implanted brain activity sensor and a wearable powered arm orthosis.

Also known as: MyoPro powered orthotic brace, Blackrock Microsystems MultiPort

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Participant must have a caregiver willing to participate in the study who will help provide care for the surgical site.
• Must be willing to live at hospital or at nearby hotel for 90-day duration when implantable components were present.
• Plateaued post-stroke recovery with complete or incomplete hemiplegia due to stroke in one upper limb, as measured on two serial occasions (at least one month apart) without improvement, by the following standardized functional assessments of the weaker upper extremity, at their worst:
• Manual Muscle Testing scores of 0/5 (no movement) or 1/5 (palpable contraction in muscle, without movement) in the biceps (elbow flexion), triceps (elbow extension), wrist flexors, wrist extensors or intrinsic hand muscles
• Mild to plegia according to Medical Research Council Scale for Muscle Strength

You may not qualify if:

• 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.
• Dementia
• Other implantable devices such as heart/brain pacemakers
• Participants who rely on ventilators
• Co-morbid conditions that would interfere with study activities or response to treatment, which may include:
• Life expectancy \< 3 years

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mijail Serruya, MD, PhD

  Dr.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: April 12, 2019
• Study Start: May 1, 2019
• Primary Completion: December 1, 2023
• Study Completion: July 1, 2024
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: The data will be available beginning 3 months and ending 5 years following publication of the first manuscript summarizing outcome measure results.
• Access Criteria: The data is available to researchers who provide a methodologically sound proposal to achieve the aims of the approved proposal. Proposals should be directed to Mijail.Serruya@jefferson.edu . To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years at a third-party website:

Locations

US (1)