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Spinal Cord Injury CervicalNCT04641793

BoMI for Muscle Control

A study of Spinal Cord Injury Cervical and Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Spinal Cord Injury Cervical, Stroke
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
20 Jan 2020to Aug 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 16 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Ages 18 and up.
  • Ability to follow simple commands, and to respond to questions.
  • 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
Show all 12Show fewer
  • 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)

Who cannot join

  • Does not meet the inclusion criteria.
  • Individuals with SCI
  • Presence of tremors, spasm and other significant involuntary movements
  • Cognitive impairment
  • Deficit of visuo-spatial orientation
  • Concurrent pressure sores or urinary tract infection
Show all 28Show fewer
  • 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:
  • 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

Trial locations and contacts

1 site in 1 country.

Ferdinando Mussa-Ivaldi, PhD contact

312 238 1230

sandro@northwestern.edu

Dalia De Santis, PhD contact

312 238 1650

ddesantis@sralab.org

United States1 site, 1 recruiting
  • Shirley Ryan Ability Lab

    Chicago, Illinois, 60611

    Ferdinando Mussa-Ivaldi, PhD, 312-238-1230, sandro@northwestern.edu

    Recruiting

Other trials in United States

About this study

Official title: Body-Machine Interface for Recovering Muscle Control

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.

Read the 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:

  1. High cost of technology and the limited amount of available hospital-based rehabilitation;
  2. 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;
  3. 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.

Being tested
Motion and Emg Control
Keywords
Motor Learning, Human Machine Interface, Neurorehabilitation, TMS, Cortico-spinal, Upper-body movements
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motion and Emg ControlDevice

    We will consider two methods for integrating motions and EMG signals:

    1. 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.
    2. 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.
Study groups in NCT04641793
Study groupRoleWhat they receive
SCIExperimentalNot described
Receives: Device: Motion and Emg Control
STROKEExperimentalNot described
Receives: Device: Motion and Emg Control
UNIMPAIREDExperimentalNot described
Receives: Device: Motion and Emg Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time

    Changing time to task completion

    Measured: during the intervention

Secondary outcomes (2)
  1. Muscle activity

    EMG activity in targeted muscles

    Measured: baseline, during the procedure, at 1 week follow-up

  2. Cortico spinal connectivity

    Motor evoked potentials in selected muscles following TMS stimulation of M1

    Measured: baseline, immediately after the intervention, at 1 week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2020
  2. Study start20 Jan 2020
  3. Primary completionAug 2024 (estimated)
  4. Study completionAug 2024 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04641793
Sponsor's protocol ID
STU00210086
Status last verified
Nov 2020
First submitted
21 Aug 2020
Last updated
24 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study of Spinal Cord Injury Cervical and Stroke, run by Shirley Ryan AbilityLab 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 12 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 24 Nov 2020. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ferdinando Mussa-Ivaldi, PhD (312 238 1230, sandro@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time (time frame: during the intervention). 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 24 Nov 2020.

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