- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06771531
Estimulación cerebral para la sensación de la planta del pie en adultos mayores con déficit somatosensorial en la planta del pie (BSFS)
Mecanismos corticales y modulación de la sensación somatosensible en adultos mayores con deficiencias somatosensoriales en la planta del pie
In older adults, diminished sensation of the legs and feet is highly prevalent and causes poor balance and reduced mobility. This type of sensation is not only dependent upon the receptors and nerves in the legs and feet, but also upon a complex central nervous system pathway that includes the cerebral cortex of the brain. This project will use a form of noninvasive brain stimulation called transcranial direct current stimulation (tDCS) to test whether increasing the excitability of the brain networks that process sensory feedback can augment foot sole sensation, balance, and mobility in older adults suffering from mild-to-moderate foot sole sensory impairments.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Junhong Zhou, PhD
- Número de teléfono: 617-971-5346
- Correo electrónico: junhongzhou@hsl.harvard.edu
Ubicaciones de estudio
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Massachusetts
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Roslindale, Massachusetts, Estados Unidos, 02131
- Reclutamiento
- Hebrew SeniorLife
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Contacto:
- Kathy Tasker
- Número de teléfono: 617-971-5351
- Correo electrónico: KathyTasker@hsl.harvard.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Aged ≥65 years.
- Self-reported feeling of unsteadiness or difficulty when standing and walking.
- Mild-to-moderate foot-sole somatosensory impairment: the ability to perceive 75g monofilament but inability to perceive 10g monofilament.
Exclusion Criteria:
- self-reported inability to stand or walk continuously for one minute without personal assistance (canes or walkers allowed);
- history or presence of foot ulceration, amputation, or deformities;
- self-reported uncontrolled pain or pain that is associated with mobility disability;
- uncontrolled diabetes mellitus;
- hospitalization within the past three months due to acute illness, or as the result of a musculoskeletal injury significantly affecting balance;
- persistent severe pain of lower extremity when standing or walking;
- diagnosis of dementia, Parkinson's disease, or stroke that affects balance;
- unstable medical condition;
- legal blindness or deafness;
- uncontrolled hypertension (i.e., systolic BP >180, diastolic BP >100 mm Hg, or prescription of ≥3 anti-hypertensive medications);
- functionally limiting nephropathy, severe diseases or transplant of the kidney or liver, renal or congestive heart failure;
- active cancer treatment;
- balance disorders due to past use of chemotherapy or history of Guillain-Barré syndrome;
- use of neuro-active or recreational drugs (e.g., sedatives, anti-psychotics), or alcohol abuse, which may affect the brain excitability;
- contraindications to MRI or tDCS (e.g., personal or family history of seizures or epilepsy, metallic or electric bio-implants, claustrophobia, brain surgery);
- persistent vertigo;
- history of Charcot-Marie-Tooth nerve disease.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: tDCS group
Participants in this arm will receive the real tDCS intervention. |
tDCS can safely and selectively modulate cortical excitability (specifically neuronal firing likelihood) by transferring weak electrical currents between scalp electrodes. The direct current delivered by any one electrode will not exceed 2.0 mA and the total amount of current from all electrodes will not exceed 4 mA in this study. |
|
Comparador falso: sham group
Participants in this arm will receive the sham stimulation as control. |
sham stimulation will implement the same protocol of the tDCS intervention; however, only very low-level currents (no more than 0.5 mA) are transferred between the same electrodes used for the tDCS throughout the 20-minute session. This strategy effectively mimics the cutaneous sensations and skin redness induced by creating only micro cortical electric fields. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
postural sway area when standing with eyes closed on the foam
Periodo de tiempo: Before and immediately after intervention
|
This metric assesses the degree to which the soft support and cut-off of the vision diminishes the control of standing posture. |
Before and immediately after intervention
|
|
Timed Up-and-Go (TUG) time
Periodo de tiempo: Before and immediately after intervention
|
This metric assesses mobility. |
Before and immediately after intervention
|
|
On-target Blood oxygen level dependent (BOLD) signal intensity in response to foot sole stimulation
Periodo de tiempo: Before and immediately after intervention
|
This metric assesses the degree to which brain cortical regions activated by the walking-related foot-sole stimulation. |
Before and immediately after intervention
|
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Standing vibratory thresholds of each foot sole
Periodo de tiempo: Before and immediately after intervention
|
This metric assesses the degree to which the foot soles can sense the vibro-tactile stimuli when standing. |
Before and immediately after intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Postural sway speed when standing with eyes closed on the foam
Periodo de tiempo: Before and immediately after intervention
|
This metric assesses the degree to which the soft support and cut-off of the vision diminishes the control of standing posture. |
Before and immediately after intervention
|
|
Gait speed of 10m walking test
Periodo de tiempo: Before and immediately after intervention
|
This metric assesses mobility. |
Before and immediately after intervention
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
BOLD signal intensity within other relevant cortical regions in response to foot sole stimulation
Periodo de tiempo: Before and immediately after intervention
|
This metric assesses the degree to which brain cortical regions activated by the walking-related foot-sole stimulation. |
Before and immediately after intervention
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pro00044674
- K01AG075180 (Subvención/contrato del NIH de EE. UU.)
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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