- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04641793
BoMI for Muscle Control
Body-Machine Interface for Recovering Muscle Control
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ferdinando Mussa-Ivaldi, PhD
- Número de teléfono: 312 238 1230
- Correo electrónico: sandro@northwestern.edu
Copia de seguridad de contactos de estudio
- Nombre: Dalia De Santis, PhD
- Número de teléfono: 312 238 1650
- Correo electrónico: ddesantis@sralab.org
Ubicaciones de estudio
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60611
- Reclutamiento
- Shirley Ryan Ability Lab
-
Contacto:
- Ferdinando Mussa-Ivaldi, PhD
- Número de teléfono: 312-238-1230
- Correo electrónico: sandro@northwestern.edu
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: SCI
|
We will consider two methods for integrating motions and EMG signals:
|
Experimental: STROKE
|
We will consider two methods for integrating motions and EMG signals:
|
Experimental: UNIMPAIRED
|
We will consider two methods for integrating motions and EMG signals:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Time
Periodo de tiempo: during the intervention
|
Changing time to task completion
|
during the intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Muscle activity
Periodo de tiempo: baseline, during the procedure, at 1 week follow-up
|
EMG activity in targeted muscles
|
baseline, during the procedure, at 1 week follow-up
|
Cortico spinal connectivity
Periodo de tiempo: baseline, immediately after the intervention, at 1 week follow-up
|
Motor evoked potentials in selected muscles following TMS stimulation of M1
|
baseline, immediately after the intervention, at 1 week follow-up
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ferdinando Mussa-Ivaldi, PhD, Northwestern University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STU00210086
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Motion and Emg Control
-
Collinge and Associates, Inc.National Cancer Institute (NCI)Terminado
-
Coapt, LLCCongressionally Directed Medical Research ProgramsTerminadoUsuario de prótesis | Amputación congénita de miembro superior | Amputación; Traumático, ExtremidadEstados Unidos
-
Coapt, LLCEunice Kennedy Shriver National Institute of Child Health and Human Development...TerminadoUsuario de prótesis | Amputación congénita de miembro superior | Amputación; Traumático, ExtremidadEstados Unidos
-
Richard H EpsteinUniversity of Miami; Society for Technology in AnesthesiaTerminado
-
Montefiore Medical CenterAgency for Healthcare Research and Quality (AHRQ)TerminadoHipertensión pediátricaEstados Unidos
-
Majmaah UniversityTerminadoSíndrome de dolor anterior de rodilla | Trastorno patelofemoralArabia Saudita
-
Tung Wah CollegeReclutamientoFractura Vertebral | Marcha, Inestable | EquilibrioHong Kong
-
University Fernando PessoaTerminadoRendimiento de las restauraciones/adhesivos dentalesPortugal
-
I.M. Sechenov First Moscow State Medical UniversityTerminado
-
North American Consortium for HistiocytosisHistiocyte SocietyReclutamientoHistiocitosis de células de LangerhansEstados Unidos