Estimulación por Interferencia Temporal sobre los Síntomas Motores en la Enfermedad de Parkinson
28 de mayo de 2026 actualizado por: Yu Liu, Shanghai University of Sport
Efectos y Mecanismos de la Estimulación Cerebral Profunda no Invasiva en Pacientes con Enfermedad de Parkinson
El objetivo de este ensayo clínico es determinar si un tipo de estimulación cerebral llamada estimulación por interferencia temporal transcraneal (TIS) del globo pálido interno (GPi) puede ayudar a mejorar los síntomas motores en personas con enfermedad de Parkinson. El estudio también examinará cómo la TIS modifica la actividad cerebral relacionada con estas mejoras.
Las principales preguntas que este estudio pretende responder son:
- ¿Cuánto pueden mejorar los síntomas motores en personas con enfermedad de Parkinson las sesiones repetidas de TIS?
- ¿Pueden estas mejoras durar hasta dos meses después de finalizar el tratamiento?
- ¿Qué cambios en la actividad cerebral ocurren junto con las mejoras?
Los investigadores compararán a las personas que reciben TIS activa con aquellas que reciben estimulación simulada (similar a un placebo) para determinar si la TIS activa conduce a mejores resultados motores.
Los participantes:
- Recibirán 10 sesiones de TIS activa o simulada durante dos semanas
- Completarán evaluaciones motoras durante las dos semanas de tratamiento y nuevamente a las 2, 4 y 8 semanas posteriores
- Completarán evaluaciones de actividad cerebral antes y después de las dos semanas de tratamiento
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
37
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200438
- Shanghai University of Sport
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
- Enfermedad de Parkinson idiopática (EP) diagnosticada por un médico según los criterios diagnósticos de la Sociedad de Trastornos del Movimiento (MDS), con inicio después de los 40 años.
- Régimen estable de medicación antiparkinsoniana, incluida la terapia con levodopa, sin cambios durante al menos 4 semanas antes y durante el ensayo.
- Estadios 1,5 a 3 de Hoehn y Yahr (H&Y) y capacidad para caminar sin ayuda.
- Ausencia de demencia, definida como una puntuación en la Evaluación Cognitiva de Montreal (MoCA) ≥ 21.
Criterios de exclusión:
- Cualquier contraindicación para la resonancia magnética (RM) o la estimulación por interferencia temporal transcraneal (TIS), incluida claustrofobia, implantes metálicos en la cabeza o el corazón, o antecedentes de terapia electroconvulsiva.
- Uso actual de medicamentos antipsicóticos, antidepresivos u otros medicamentos que modulan la dopamina.
- Presencia de afecciones ortopédicas que puedan interferir con las evaluaciones motoras, como osteoartritis o cirugía ortopédica reciente (en los últimos 6 meses).
- Antecedentes de enfermedad psiquiátrica mayor diagnosticada por un médico.
- Riesgos cardiovasculares diagnosticados por un médico que puedan contraindicar el ejercicio o la participación en el estudio.
- Antecedentes de cirugía de estimulación cerebral profunda (ECP).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Grupo TIS
Los participantes en este brazo recibirán estimulación activa por interferencia temporal transcraneal dirigida al globo pálido interno durante un período de intervención de dos semanas.
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La estimulación por interferencia temporal transcraneal (TIS) es una técnica de estimulación cerebral no invasiva que administra dos corrientes alternas de alta frecuencia a través de electrodos en el cuero cabelludo para generar un campo de interferencia de baja frecuencia en regiones cerebrales profundas.
En este estudio, la TIS se dirige al globo pálido interno (GPi) para modular la actividad neuronal en personas con enfermedad de Parkinson.
Los participantes reciben 10 sesiones de estimulación durante dos semanas.
La condición de TIS simulada utiliza la misma configuración pero aplica corrientes de baja frecuencia sin generar un patrón de interferencia.
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Comparador falso: Sham Group
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention.
However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations.
The sham procedure consists of 10 sessions delivered over a two-week period, without therapeutic stimulation.
|
La estimulación por interferencia temporal transcraneal (TIS) es una técnica de estimulación cerebral no invasiva que administra dos corrientes alternas de alta frecuencia a través de electrodos en el cuero cabelludo para generar un campo de interferencia de baja frecuencia en regiones cerebrales profundas.
En este estudio, la TIS se dirige al globo pálido interno (GPi) para modular la actividad neuronal en personas con enfermedad de Parkinson.
Los participantes reciben 10 sesiones de estimulación durante dos semanas.
La condición de TIS simulada utiliza la misma configuración pero aplica corrientes de baja frecuencia sin generar un patrón de interferencia.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score
Periodo de tiempo: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change in motor symptoms assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III).
The total score ranges from 0 to 132, with higher scores indicating more severe motor impairment (worse outcome).
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Participants With a ≥5-point Reduction From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score
Periodo de tiempo: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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A responder was defined as a participant with a reduction of at least 5 points from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) total score.
Scores range from 0 to 132, with higher scores indicating more severe motor impairment; therefore, a reduction in score indicates improvement.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-I (MDS-UPDRS I) Score
Periodo de tiempo: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change in non-motor symptoms assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-I (MDS-UPDRS I) (Non-Motor Experiences of Daily Living).
The total score ranges from 0 to 52, with higher scores indicating more severe non-motor symptoms (worse outcome).
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-II (MDS-UPDRS II) Score
Periodo de tiempo: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change in motor symptoms affecting daily living assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-II (MDS-UPDRS II) (Motor Experiences of Daily Living).
The total score ranges from 0 to 52, with higher scores indicating more severe motor difficulties in daily living (worse outcome).
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Epworth Sleepiness Scale Score
Periodo de tiempo: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change in daytime sleepiness assessed using the Epworth Sleepiness Scale .
The Epworth Sleepiness Scale is a self-administered questionnaire consisting of 8 items, with total scores ranging from 0 to 24, where higher scores indicate greater daytime sleepiness (worse outcome).
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Parkinson's Disease Sleep Scale-2 Score
Periodo de tiempo: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change in sleep disturbances assessed using the Parkinson's Disease Sleep Scale-2. The Parkinson's Disease Sleep Scale-2 is a patient-reported questionnaire consisting of 15 items, with total scores ranging from 0 to 60, where higher scores indicate more severe sleep disturbances (worse outcome). |
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Gait Performance Measures
Periodo de tiempo: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Changes in gait performance will be assessed using an instrumented gait mat during single-task and dual-task walking conditions. Spatiotemporal gait parameters, including gait speed, step length, stride length, step width, cadence, and gait variability, will be collected during standardized walking trials. Improvements in gait performance are indicated by increased gait speed, longer step and stride length, and reduced gait variability under both single-task and dual-task conditions. |
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Balance Performance Measures
Periodo de tiempo: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Changes in balance performance will be assessed using a force platform during standardized standing balance tasks. Center of pressure (COP) parameters, including COP path length, sway area, and sway velocity, will be derived from force platform recordings to quantify postural stability. Improved balance performance is indicated by reduced COP displacement, smaller sway area, and lower sway velocity. |
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Magnetic Resonance Imaging (MRI) Measures
Periodo de tiempo: Baseline and immediately after the intervention
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Changes in brain structure and/or function will be assessed using magnetic resonance imaging (MRI). MRI data will be acquired to evaluate intervention-related changes in brain regions associated with motor control. Imaging-derived measures may include structural and functional metrics obtained from standardized MRI protocols. |
Baseline and immediately after the intervention
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Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-bradykinesia Subscore
Periodo de tiempo: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the bradykinesia subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III).
The total bradykinesia subscore ranges from 0 to 48, with higher scores indicating more severe bradykinesia.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-rigidity Subscore
Periodo de tiempo: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the rigidity subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III).
The total rigidity subscore ranges from 0 to 20, with higher scores indicating more severe rigidity.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-axial Subscore
Periodo de tiempo: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the axial signs subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III).
The total axial signs subscore ranges from 0 to 20, with higher scores indicating more severe axial motor impairment.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-tremor Subscore
Periodo de tiempo: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the tremor subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III).
The total tremor subscore ranges from 0 to 40, with higher scores indicating more severe tremor.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in the Home Diary Assessment of Motor States (Medication-ON Without Dyskinesia)
Periodo de tiempo: Baseline, weekly averages during weeks 1 and 2 of the intervention
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The motor state will be recorded by participants using a self-completed home diary during waking hours in 30-minute intervals from awakening until bedtime. For each interval, participants will record one of the following motor states: ON with good control, ON with mild dyskinesia, ON with severe dyskinesia, or OFF. Baseline assessment will be defined as the average percentage of waking time spent in ON states over three consecutive days immediately prior to the intervention. The 1-week assessment will be defined as the average percentage of waking time spent in ON states over the five intervention days of the first intervention week, and the 2-week assessment as the average over the five intervention days of the second intervention week. The outcome measure is defined as the percentage of total recorded waking time spent in ON states, calculated from the home diary data. A higher percentage of time spent in ON states indicates milder motor symptoms and better motor control. |
Baseline, weekly averages during weeks 1 and 2 of the intervention
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Change From Baseline in the Home Diary Assessment of Motor States (Medication-OFF)
Periodo de tiempo: Baseline, weekly averages during weeks 1 and 2 of the intervention
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The motor state will be recorded by participants using a self-completed home diary during waking hours in 30-minute intervals from awakening until bedtime. For each interval, participants will record one of the following motor states: ON with good control, ON with mild dyskinesia, ON with severe dyskinesia, or OFF. Baseline assessment will be defined as the average percentage of waking time spent in the Medication-OFF state over three consecutive days immediately prior to the intervention. Week 1 and Week 2 assessments will be calculated as the average percentage of waking time spent in the Medication-OFF state over the five intervention days of each intervention week. The outcome measure is defined as the percentage of total recorded waking time spent in the Medication-OFF state, calculated from the home diary data. A lower percentage of time spent in the Medication-OFF state indicates milder motor symptoms and better motor control. |
Baseline, weekly averages during weeks 1 and 2 of the intervention
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Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index
Periodo de tiempo: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change in quality of life assessed using the Parkinson's Disease Questionnaire-39 (PDQ-39).
The PDQ-39 consists of 39 items across 8 domains, with total scores ranging from 0 to 100, where higher scores indicate poorer health-related quality of life (worse outcome).
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Mobility Domain Score
Periodo de tiempo: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the mobility domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease.
Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer mobility-related quality of life.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Activities of Daily Living Domain Score
Periodo de tiempo: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the activities of daily living domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease.
Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of daily living-related quality of life.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Emotional Well-being Domain Score
Periodo de tiempo: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the emotional well-being domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease.
Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of emotional well-being-related quality of life.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Stigma Domain Score
Periodo de tiempo: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the stigma domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease.
Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of stigma-related quality of life.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Social Support Domain Score
Periodo de tiempo: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the social support domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease.
Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of social support-related quality of life.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Cognitions Domain Score
Periodo de tiempo: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the cognitions domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease.
Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of cognitions-related quality of life.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Communication Domain Score
Periodo de tiempo: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the communication domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease.
Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of communication-related quality of life.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Bodily Discomfort Domain Score
Periodo de tiempo: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the bodily discomfort domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease.
Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of bodily discomfort-related quality of life.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
29 de diciembre de 2025
Finalización primaria (Actual)
15 de abril de 2026
Finalización del estudio (Actual)
15 de abril de 2026
Fechas de registro del estudio
Enviado por primera vez
15 de noviembre de 2025
Primero enviado que cumplió con los criterios de control de calidad
28 de diciembre de 2025
Publicado por primera vez (Actual)
30 de diciembre de 2025
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 102772024RT146
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .