kTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery (KULMINATE) Pilot
kTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The goal of this pilot clinical trial is to assess the feasibility and preliminary efficacy of kTMP on upper limb motor recovery in chronic stroke compared to sham. We will conduct a 6-week double-blind, randomized, sham-controlled pilot study to test the beneficial influence of kTMP combined with simple motor tasks on kinematic outcomes such as range of motion of the upper arm, hand and fingers.
After baseline assessments, participants will be randomly allocated to either the kTMP group or the Control group. Participants, experimentalists, and outcome assessors will be blinded to group allocation. kTMP will begin within 1 week following randomization and will be delivered three times a week for 6 weeks. The primary endpoint will be assessed at the end of treatment, with follow-up assessments occurring 1 month, 3 months and 6 months following treatment completion. There is one assessment 4 weeks into the treatment phase to assess if patients continue to improve from 4 to 6 weeks of treatment.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ludovica Labruna, PhD
- Número de teléfono: 5104237125
- Correo electrónico: participate@magnetictides.com
Ubicaciones de estudio
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California
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San Francisco, California, Estados Unidos, 94158
- Reclutamiento
- UCSF Mission Bay- Sandler Neurosciences Center
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Contacto:
- Christina Merrick
- Número de teléfono: 510-423-7125
- Correo electrónico: participate@magnetictides.com
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Investigador principal:
- Ludovica Labruna, PhD
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Investigador principal:
- Richard Ivry, PhD
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Investigador principal:
- Karunesh Ganguly, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion criteria:
- Adults aged 18-80 years who have a history of an ischemic or hemorrhagic stroke ≥ 12 m prior to enrollment.
- Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 20-50.
- Ability to communicate, understand, and give appropriate consent. Participants can follow two-step commands.
- Motor evoked potentials in a hand muscle when stimulating ipsilesional cortex with suprathreshold single-pulse TMS (MEP positive).
Exclusion criteria:
- Participants with moderate or severe cognitive impairment (MoCA < 18).
- Participants with sensory deficits FMA-S < 6/12 (with proprioception < 4/8).
- Participants with severe apraxia (TULIA < 5).
- Language impairment or behavioral disorder that interferes with their ability to adhere to the protocol or to provide informed consent.
- Individuals who have a serious uncontrolled medical condition, including but not limited to severe cardiovascular and cardiopulmonary disease.
- Pregnancy or plans to become pregnant during the study period.
- Botulinum toxin injections of the affected upper extremity within 3 months prior to onset of study.
- Severe spasticity of the affected upper limb (Modified Ashworth ≥ 4).
- Absolute contraindications related to non-invasive brain stimulation, including:
9a) History of seizures in the last 12 months while taking anti-epilepsy medication 9b) Presence of any metal implants in the head (excluding the mouth), such as cortical stimulators and DBS, clips, coils, shunts, stents or skull plates, cochlear implants 9c) Permanent eye liner or head tattoos 9d) Implanted electronics such as pacemakers, defibrillators, intrathecal baclofen pumps or vagus nerve stimulator 9e) History of experiencing a serious adverse event during a previous transcranial magnetic stimulation (TMS) session
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: KTMP activo
Los participantes recibieron 8 v/m de estimulación activa
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Una nueva herramienta de estimulación cerebral no invasiva
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Comparador falso: Sham kTMP
Participants receive sham stimulation (0.0 V/m electric field)
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Una nueva herramienta de estimulación cerebral no invasiva con configuración simulada seleccionada
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Range of Joint Motion (ROM)
Periodo de tiempo: 6 weeks
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defined as the standard deviation of the joint angle time series for a given trial.
The median ROM will be calculated for eleven degrees of freedom and then averaged.
If there are joints which appear to be compensatory, they will be removed from the analysis
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6 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fugl- Meyer Assessment (Upper Extremity)
Periodo de tiempo: 6 weeks
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A comprehensive clinical examination that has been widely used to evaluate stroke-related motor impairment.
It is graded from 0 (hemiplegia) to 66 for the Upper extremity.
Higher scores signifies better motor control, and hence a better outcome.
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6 weeks
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Modified Ashworth Scale (MAS)
Periodo de tiempo: 6 weeks
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Used to measure spasticity in wrist and hand flexors and extensors.
It assigns a grade of spasticity from 0-4.
Lower scores represent normal muscle tone and higher scores represent spasticity.
Hence lower scores are associated with better outcomes.
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6 weeks
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Transport Time
Periodo de tiempo: 6 weeks
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Calculated for each of three epochs, pre, during and post
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6 weeks
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Trial to Trial Variability (T2TV)
Periodo de tiempo: 6 weeks
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Defined as the mean-squared error between the joint angle time-series for a given trial and the median joint angle timeseries.
The median T2TV will be calculated for eleven degrees of freedom.
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6 weeks
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Grasp to Lift Time
Periodo de tiempo: 6 weeks
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Calculated for each of three epochs, pre, during and post
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6 weeks
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- Carrera
- Estimulación Magnética Transcraneal
- Accidente cerebrovascular isquémico
- Estimulación cerebral no invasiva
- Excitabilidad cortical
- Accidente cerebrovascular crónico
- Plasticidad
- Trastornos cerebrovasculares
- Trastornos cerebrales
- Trastornos del sistema nervioso central
- Infarto hemorragico
- Desordenes cardiovasculares
- ktmp
- Perturbación magnética transcraneal en kilohercios
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- kTMPstrokePilot
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
producto fabricado y exportado desde los EE. UU.
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