BoMI for Muscle Control
Primary Purpose
Spinal Cord Injury Cervical, Stroke
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motion and Emg Control
Sponsored by
About this trial
This is an interventional other trial for Spinal Cord Injury Cervical focused on measuring Motor Learning, Human Machine Interface, Neurorehabilitation, TMS, Cortico-spinal, Upper-body movements
Eligibility Criteria
Uninjured individuals
Inclusion criteria:
- Ages 18 and up.
- Ability to follow simple commands, and to respond to questions.
Exclusion criteria for SCI participants:
• Does not meet the inclusion criteria.
Individuals with SCI
Inclusion criteria:
- Age 16-65
- Injuries at the C3-6 level, complete (ASIA A), or incomplete (ASIA B and C).
- Able to follow simple commands
- Able to speak or respond to questions
Exclusion criteria:
- Presence of tremors, spasm and other significant involuntary movements
- Cognitive impairment
- Deficit of visuo-spatial orientation
- Concurrent pressure sores or urinary tract infection
- Other uncontrolled infection, concurrent cardiovascular disease
- Sitting tolerance less than one hour
- Severe hearing or visual deficiency
- Miss more than six appointments without notification
- Unable to comply with any of the procedures in the protocol
- Unable to provide informed consent
- Stroke survivors:
Inclusion criteria:
- Recent stroke (Sub acute to early chronic, between 3 and 12 months from CVA)
- Age less than 75 (To avoid age-related confounds)
- Inability to operate a manual wheelchair
- Available medical records and radiographic information about lesion locations
- Significant level of hemiparesis (UE Fugl Meyer score between 10 and 30)
- Presence of pathological muscle synergies in the UE (flexor and/or extensor synergy)
Exclusion criteria:
- Aphasia, apraxia, cognitive impairment or affective dysfunction that would influence the ability to perform the experiment
- Inability to provide informed consent
- Severe spasticity, contracture, shoulder subluxation, or UE pain
- Severe current medical problems, including rheumatoid arthritis or other orthopaedic impairments restricting finger or wrist movement
Additional exclusion criteria for participants enrolled in TMS procedures
- Any metal in head with the exception of dental work or any ferromagnetic metal elsewhere in the body. This applies to all metallic hardware such as cochlear implants, or an Internal Pulse Generator or medication pumps, implanted brain electrodes, and peacemaker.
- Personal history of epilepsy (untreated with one or a few past episodes), or treated patients
- Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without history of seizure, and without anticonvulsant medication
- Administration of drugs that potentially lower seizure threshold [REF], without concomitant administration of anticonvulsant drugs which potentially protect against seizures occurrence
- Change in dosage for neuro-active medications (Baclophen, Lyrica, Celebrex, Cymbalta, Gabapentin, Naprosyn, Diclofenac, Diazepam, Tramadol, etc) within 2 weeks of any study visit.
- Skull fractures, skull deficits or concussion within the last 6 months
- unexplained recurring headaches
- Sleep deprivation, alcoholism
- Claustrophobia precluding MRI
- Pregnancy
Sites / Locations
- Shirley Ryan Ability LabRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
SCI
STROKE
UNIMPAIRED
Arm Description
Outcomes
Primary Outcome Measures
Time
Changing time to task completion
Secondary Outcome Measures
Muscle activity
EMG activity in targeted muscles
Cortico spinal connectivity
Motor evoked potentials in selected muscles following TMS stimulation of M1
Full Information
NCT ID
NCT04641793
First Posted
August 21, 2020
Last Updated
November 17, 2020
Sponsor
Shirley Ryan AbilityLab
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
1. Study Identification
Unique Protocol Identification Number
NCT04641793
Brief Title
BoMI for Muscle Control
Official Title
Body-Machine Interface for Recovering Muscle Control
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
People with spinal cord injury (SCI), stroke and other neurodegenerative disorders can follow two pathways for regaining independence and quality of life. One is through clinical interventions, including therapeutic exercises. The other is provided by assistive technologies, such as wheelchairs or robotic systems. In this study, we combine these two paths within a single framework by developing a new generation of body-machine interfaces (BoMI) supporting both assistive and rehabilitative goals. In particular, we focus on the recovery of muscle control by including a combination of motion and muscle activity signals in the operation of the BoMI.
Detailed Description
When suffering from conditions affecting the central nervous system, such as spinal cord injury (SCI), stroke or neurodegenerative disorders, two pathways are available for regaining independence and quality of life. One way is through clinical interventions, including therapeutic exercises, often in combination with pharmacological agents. The other is provided by assistive technologies, such as wheelchairs or robotic systems. These two approaches have conflicting characteristics. While rehabilitation exercises challenge patients to use the most affected parts of their musculoskeletal apparatus, assistive technologies are typically designed to bypass the disability. This has led to divergent research domains. In both fields there are three major gaps that we plan to address in the investigator's research:
High cost of technology and the limited amount of available hospital-based rehabilitation;
Lack of adaptability of currently available assistive technologies, such as head switches and sip-and puff devices, that require users to overcome a hard learning barrier;
Inadequate criteria for assessment of effectiveness of therapy, with common techniques still relying on subjective approaches that are inadequate considering the current state of biomedical science and technology.
We will address all of these issues by developing a new generation of body-machine interfaces (BoMI) supporting both assistive and rehabilitative goals. BMIs will translate movement signals and muscle activities of the user into control signals for assistive devices and computer systems. State-of-the-art systems for surface electromyography (EMG) and movement recording (IMU) will be integrated through machine learning techniques to facilitate sensorimotor learning while providing the means to promote or reduce the use of targeted muscles. New comprehensive assessment techniques will be developed by integrating standard measure of function - as the manual muscle test - with EMG analysis and non-invasive magnetic brain stimulation (TMS) (Magstim 200 Bistim, Whitland, UK). The development will be organized in three specific aims.
AIM 1: To develop a BMI integrating muscle activities and motion signals for operating external devices and performing rehabilitation exercises. EMG signals derived from multiple muscles in the upper body (e.g. deltoid, pectoralis, trapezius, triceps, etc.) will be integrated with motion signals to generate control signals for external devices (e.g. the coordinates of a cursor on a computer monitor or the speed and direction commands to a powered wheelchair). Both linear (PCA) and nonlinear maps (auto encoder networks) will be explored, although current preliminary evidence suggests that non-linear auto encoders (AE) are likely to better facilitate user learning1.
AIM 2: To enable targeting and modulating recruitment of specific muscles and muscle synergies during the practice of games and functional tasks. To enhance or reduce the role of a muscle or synergy, the output of the BoMI will be modulated in proportion to the deviation of the measured muscle activity from the desired level. The effectiveness of the approach will be tested at different times following training, both by tracking of motions and EMG activities during the performance of selected activities of daily living (ADL) and trough the assessment of muscle responses evoked by non-invasive brain stimulation.
AIM 3: To promote the adoption of the BoMI by facilitating access to its functions by patients and therapists and by performing an observational study on uptake in the DayRehabTM environment. The Shirley Ryan Ability Lab has established a unique environment in which spinal cord injured and stroke outpatients engage in daily rehabilitation exercises in close physical proximity with researchers. We will seize this opportunity to introduce the BoMI in the context of clinical therapy thus allowing a direct assessment of acceptance by therapists and clients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury Cervical, Stroke
Keywords
Motor Learning, Human Machine Interface, Neurorehabilitation, TMS, Cortico-spinal, Upper-body movements
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SCI
Arm Type
Experimental
Arm Title
STROKE
Arm Type
Experimental
Arm Title
UNIMPAIRED
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Motion and Emg Control
Intervention Description
We will consider two methods for integrating motions and EMG signals:
Direct methods. Signals extracted from the latent EMG space will directly contribute to the control of the external device. We will integrate EMG and IMU in two ways. In a first scenario, EMG and IMU will be given variable weight in the control. In a second scenario (perturbative method) the distance of ongoing muscle patterns from a desired set of strategies will modulate the mapping from body to cursor motions in the form of assistive (i.e. the cursor moves faster towards the target) or resistive (i.e. the cursor slows down) influences on cursor movement.
Indirect Methods. Signals extracted by EMG will modulate the feedback offered to the learner to penalize deviations from desired muscle patterns. When multiple ways to perform a movement are offered by redundancy, (i.e., by the multiplicity of muscles compared to task demands), the brain chooses solutions that minimize noise and uncertainty.
Primary Outcome Measure Information:
Title
Time
Description
Changing time to task completion
Time Frame
during the intervention
Secondary Outcome Measure Information:
Title
Muscle activity
Description
EMG activity in targeted muscles
Time Frame
baseline, during the procedure, at 1 week follow-up
Title
Cortico spinal connectivity
Description
Motor evoked potentials in selected muscles following TMS stimulation of M1
Time Frame
baseline, immediately after the intervention, at 1 week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Uninjured individuals
Inclusion criteria:
Ages 18 and up.
Ability to follow simple commands, and to respond to questions.
Exclusion criteria for SCI participants:
• Does not meet the inclusion criteria.
Individuals with SCI
Inclusion criteria:
Age 16-65
Injuries at the C3-6 level, complete (ASIA A), or incomplete (ASIA B and C).
Able to follow simple commands
Able to speak or respond to questions
Exclusion criteria:
Presence of tremors, spasm and other significant involuntary movements
Cognitive impairment
Deficit of visuo-spatial orientation
Concurrent pressure sores or urinary tract infection
Other uncontrolled infection, concurrent cardiovascular disease
Sitting tolerance less than one hour
Severe hearing or visual deficiency
Miss more than six appointments without notification
Unable to comply with any of the procedures in the protocol
Unable to provide informed consent
Stroke survivors:
Inclusion criteria:
Recent stroke (Sub acute to early chronic, between 3 and 12 months from CVA)
Age less than 75 (To avoid age-related confounds)
Inability to operate a manual wheelchair
Available medical records and radiographic information about lesion locations
Significant level of hemiparesis (UE Fugl Meyer score between 10 and 30)
Presence of pathological muscle synergies in the UE (flexor and/or extensor synergy)
Exclusion criteria:
Aphasia, apraxia, cognitive impairment or affective dysfunction that would influence the ability to perform the experiment
Inability to provide informed consent
Severe spasticity, contracture, shoulder subluxation, or UE pain
Severe current medical problems, including rheumatoid arthritis or other orthopaedic impairments restricting finger or wrist movement
Additional exclusion criteria for participants enrolled in TMS procedures
Any metal in head with the exception of dental work or any ferromagnetic metal elsewhere in the body. This applies to all metallic hardware such as cochlear implants, or an Internal Pulse Generator or medication pumps, implanted brain electrodes, and peacemaker.
Personal history of epilepsy (untreated with one or a few past episodes), or treated patients
Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without history of seizure, and without anticonvulsant medication
Administration of drugs that potentially lower seizure threshold [REF], without concomitant administration of anticonvulsant drugs which potentially protect against seizures occurrence
Change in dosage for neuro-active medications (Baclophen, Lyrica, Celebrex, Cymbalta, Gabapentin, Naprosyn, Diclofenac, Diazepam, Tramadol, etc) within 2 weeks of any study visit.
Skull fractures, skull deficits or concussion within the last 6 months
unexplained recurring headaches
Sleep deprivation, alcoholism
Claustrophobia precluding MRI
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ferdinando Mussa-Ivaldi, PhD
Phone
312 238 1230
Email
sandro@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dalia De Santis, PhD
Phone
312 238 1650
Email
ddesantis@sralab.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferdinando Mussa-Ivaldi, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan Ability Lab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ferdinando Mussa-Ivaldi, PhD
Phone
312-238-1230
Email
sandro@northwestern.edu
12. IPD Sharing Statement
Learn more about this trial
BoMI for Muscle Control
We'll reach out to this number within 24 hrs