Stroke, ComplicationCortimoNCT03913286
Neuromotor Prosthetic to Treat Stroke-Related Paresis
A study testing Cortimo in people with Stroke, Complication and Stroke, run by Thomas Jefferson University at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Complication, Stroke, Stroke Sequelae
- What is being tested?
- Cortimo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- > 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
- Fugl-Meyer Motor Impairment Score of 38 or lower
- Action Research Arm Test (ARAT) score of 35 or lower
- Motricity Index score of 55 or lower
- No joint contracture or severe spasticity in affected upper limb precluding the operation of the MyoPro orthotic device.
- Sufficient sitting balance to participate with robotic brace activities.
- No condition (e.g., severe arthritis, central pain) that would interfere with administration of motor function tests, ability to understand verbal commands and cooperate with test procedures.
Who cannot join
- 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
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- 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
- Severe chronic pulmonary disease
- Seizure within three months prior to enrollment
- History of uncontrolled seizures
- Local, systemic acute or chronic infectious illness
- Life threatening cardiac arrhythmias
- Severe collagen vascular disorder
- Kidney failure or other major organ system failures History of a neurological ablation procedure.
- Labeled contraindication for MRI.
- History of HIV infection or ongoing chronic infection (such as tuberculosis).
- Pregnant or of child-bearing potential and are not taking acceptable methods of contraception.
- Participation in another investigational device or medication trial
- Excessive pain in the paretic upper extremity (> 5 on a 10-point visual analog scale)
- Excessive spasticity at the paretic elbow, wrist, or digits as defined as a score of > 2 on the Modified Ashworth Spasticity Scale
- Participating in any experimental rehabilitation or drug studies
- Moderate to severe apraxia (< 2.5 on the Alexander scale)
- Received phenol injections to any portion of the paretic upper extremity within the past 12 months
- Other conditions or circumstances that, in the opinion of the investigators, would preclude safe and/or effective participation, including severe skin conditions, and/or other sequelae that may be contraindicated for arm orthosis use as well as personal circumstance
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
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
Read the 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).
- Conditions
- Stroke, Complication, Stroke, Stroke Sequelae, Hemiparesis, Arm Paralysis
- Being tested
- Cortimo
- Keywords
- neuroprosthetic, neuroprosthesis, brain-computer, brain-machine, microelectrode, Utah array, orthosis, brain computer interface, assistive device, Neurorehabilitation, neurotechnology
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CortimoDevice
Also called MyoPro powered orthotic brace, Blackrock Microsystems MultiPort
The Cortimo comprises an implanted brain activity sensor and a wearable powered arm orthosis.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The participant will be implanted with the Blackrock Microsystems MultiPort system. Receives: Device: Cortimo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 months
Secondary outcomes (1)
Change from Baseline Braden skin health score at 4 months
The Braden scale predicts pressure sore risk. The Braden score consists of 6 categories: sensory perception, moisture, activity, mobility, nutrition and friction. The score ranges from 6-23 with lower scores indicating a higher risk.
From: Bergstrom et al. The Braden Scale for Predicting Pressure Sore Risk. Nurs. Res. 36(4): 205-210. 1987.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start1 May 2019
- Primary completion1 Dec 2023
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, ComplicationStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mijail Serruya, MD, PhD, Principal investigator, Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913286
- Sponsor's protocol ID
- 17D.459
- Acronym
- Cortimo
- Status last verified
- Apr 2025
- First submitted
- 7 Mar 2019
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The individual participant data are available. The individual participant data comprises those that underlie the results reported in the first article describing outcome measures after deidentification. Other documents available are the Study Protocol and the Analytic Code.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromotor Prosthetic to Treat Stroke-Related Paresis
- ClinicalTrials.gov ID
- NCT03913286
- Acronym / sponsor ID
- Cortimo / 17D.459
- Conditions
- Stroke, Complication, Stroke, Stroke Sequelae, Hemiparesis, Arm Paralysis
- Keywords
- neuroprosthetic, neuroprosthesis, brain-computer, brain-machine, microelectrode, Utah array, orthosis, brain computer interface
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 12 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: CortimoThe participant will be implanted with the Blackrock Microsystems MultiPort system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CortimoAlso: MyoPro powered orthotic brace, Blackrock Microsystems MultiPortThe Cortimo comprises an implanted brain activity sensor and a wearable powered arm orthosis. | Device | Intervention |
Primary outcome
Change from Baseline Fugl-Meyer Motor Impairment Score at 4 months
Time frame: 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.
Change from Baseline Action Research Arm Test (ARAT) score at 4 months
Time frame: 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.
Change from Baseline Motricity Index score at 4 months
Time frame: 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.
Change from Baseline ADL, Hand and Recovery Scales within Stroke Impact Scale, at 4 months
Time frame: 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.
1 secondary outcome
Change from Baseline Braden skin health score at 4 months
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: Yes. The individual participant data are available. The individual participant data comprises those that underlie the results reported in the first article describing outcome measures after deidentification. Other documents available are the Study Protocol and the Analytic Code.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mijail Serruya, MD, PhD principal investigator
Dr.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cortimo in people with Stroke, Complication and Stroke, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Fugl-Meyer Motor Impairment Score at 4 months (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.