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BoMI for Muscle Control in Spinal Cord Injury
N/A
Recruiting
Led By Ferdinando Mussa-Ivaldi, PhD
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age less than 75 (To avoid age-related confounds) for stroke survivors
Able to follow simple commands for individuals with SCI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediately after the intervention, at 1 week follow-up
Awards & highlights
Study Summary
This trial combined two methods for helping people with spinal cord injury, stroke, or other neurodegenerative disorders regain independence and quality of life: clinical interventions (therapeutic exercises) and assistive technologies (wheelchairs or robotic systems). The new generation of body-machine interfaces (BoMI) developed in this study supports both assistive and rehabilitative goals. In particular, the BoMI is designed to help people recover muscle control by using a combination of motion and muscle activity signals.
Who is the study for?
This trial is for adults with spinal cord injuries (C3-6 level, ASIA A-C) or recent stroke survivors who have significant hemiparesis and pathological muscle synergies. Participants must be able to follow commands and respond to questions. Exclusions include severe medical conditions, metal in the body incompatible with TMS procedures, cognitive impairments, and inability to comply with study protocols.Check my eligibility
What is being tested?
The study tests a new type of body-machine interface (BoMI) that combines motion and muscle activity signals to help regain muscle control. It aims at enhancing both assistive technologies like wheelchairs and therapeutic exercises for rehabilitation purposes.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include discomfort from using the BoMI device or fatigue during therapy sessions. There could also be risks associated with Transcranial Magnetic Stimulation (TMS), such as headaches or seizures if applicable.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a stroke survivor under 75 years old.
Select...
I can understand and follow basic instructions.
Select...
I can speak or respond to questions despite my spinal cord injury.
Select...
My spinal cord injury is between the C3 and C6 levels, and it's either complete or incomplete.
Select...
I cannot use a manual wheelchair due to my stroke.
Select...
I am between 16 and 65 years old with a spinal cord injury.
Select...
I have significant weakness on one side of my body after a stroke.
Select...
I have muscle coordination issues in my arm due to a stroke.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time
Secondary outcome measures
Cortico spinal connectivity
Muscle activity
Trial Design
3Treatment groups
Experimental Treatment
Group I: UNIMPAIREDExperimental Treatment1 Intervention
Group II: STROKEExperimental Treatment1 Intervention
Group III: SCIExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
71 Previous Clinical Trials
9,069 Total Patients Enrolled
Shirley Ryan AbilityLabLead Sponsor
194 Previous Clinical Trials
16,852 Total Patients Enrolled
Ferdinando Mussa-Ivaldi, PhDPrincipal Investigator - Northwestern University
Shirley Ryan AbilityLab
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot sit for more than an hour due to my spinal cord injury.I am a stroke survivor under 75 years old.I have a brain condition not caused by seizures and I'm not on seizure medication.I often have headaches for no known reason.I can understand and follow basic instructions.I had a stroke between 3 and 12 months ago.I can speak or respond to questions despite my spinal cord injury.My spinal cord injury is between the C3 and C6 levels, and it's either complete or incomplete.I am taking medication that could lower my seizure threshold but am not on any anticonvulsant drugs.I have pressure sores or a urinary infection with my spinal cord injury.You have an uncontrolled infection or a heart condition if you have spinal cord injury.I have epilepsy, either untreated or treated, and am enrolled in TMS procedures.You have trouble thinking clearly or remembering things because of a spinal cord injury.I do not have severe arthritis or other conditions that limit my hand movement.I have severe muscle stiffness, joint issues, shoulder dislocation, or arm pain after a stroke.I haven't changed my neuro-active medication dose in the last 2 weeks.I do not have speech, movement, thinking, or mood problems that would affect my participation.I have severe hearing or vision problems due to my spinal cord injury.I have not had a skull fracture, skull deficit, or concussion in the last 6 months.You are afraid of being in small, enclosed spaces, which would make it difficult for you to have a MRI scan during the study.I am 18 years old or older.You should not have sleep problems or be addicted to alcohol if you are taking part in TMS procedures.I have my medical records and images showing where my stroke affected me.I experience tremors or involuntary movements due to my spinal cord injury.I cannot use a manual wheelchair due to my stroke.I can understand and follow simple instructions.I am between 16 and 65 years old with a spinal cord injury.I have trouble understanding where objects are in space due to my spinal cord injury.I have significant weakness on one side of my body after a stroke.I have muscle coordination issues in my arm due to a stroke.
Research Study Groups:
This trial has the following groups:- Group 1: SCI
- Group 2: UNIMPAIRED
- Group 3: STROKE
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial accommodate geriatric patients?
"This clinical trial has established eligibility criteria that requires applicants to be between 16 and 65 years old. Separate studies exist for those under 18 (71) and individuals over 65 (1291)."
Answered by AI
How many research participants are partaking in this clinical experiment?
"Affirmative. The clinical trial's information on the website clinicaltrials.gov confirms that it is actively recruiting patients since its initial post on January 20th 2020, with an update November 17th 2020. This study requires 60 participants to be recruited from one site in particular."
Answered by AI
Is it possible for me to enroll in this clinical experiment?
"Up to 60 individuals between the ages of 16 and 65, who have suffered a stroke, can participate in this trial. To be eligible for consideration, applicants must possess the capability to obey straightforward instructions and answer questions as well as being physically healthy with an age higher than 18 years old."
Answered by AI
Are there still openings available for participation in this research trial?
"The clinical trial's listing on the government-sponsored platform, clinicaltrials.gov, confirms that this research is presently recruiting participants. It was first posted in January 20 2020 and underwent its latest update on November 17 2020."
Answered by AI
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