Estimulação por Interferência Temporal nos Sintomas Motores da Doença de Parkinson
28 de maio de 2026 atualizado por: Yu Liu, Shanghai University of Sport
Efeitos e Mecanismos da Estimulação Cerebral Profunda Não Invasiva em Doentes com Doença de Parkinson
O objetivo deste ensaio clínico é perceber se um tipo de estimulação cerebral chamada estimulação por interferência temporal transcraniana (TIS) do globo pálido interno (GPi) pode ajudar a melhorar os sintomas motores em pessoas com doença de Parkinson. O estudo também irá analisar como a TIS altera a atividade cerebral relacionada com estas melhorias.
As principais questões que este estudo pretende responder são:
- Até que ponto podem as sessões repetidas de TIS melhorar os sintomas motores em pessoas com doença de Parkinson?
- Podem estas melhorias durar até dois meses após o término do tratamento?
- Que alterações na atividade cerebral ocorrem em conjunto com as melhorias?
Os investigadores irão comparar pessoas que recebem TIS ativa com aquelas que recebem estimulação simulada (semelhante a placebo) para verificar se a TIS ativa leva a melhores resultados motores.
Os participantes irão:
- Receber 10 sessões de TIS ativa ou simulada ao longo de duas semanas
- Realizar avaliações motoras durante as duas semanas de tratamento e novamente 2, 4 e 8 semanas depois
- Realizar avaliações da atividade cerebral antes e depois das duas semanas de tratamento
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
37
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200438
- Shanghai University of Sport
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Critérios de Inclusão:
- Doença de Parkinson idiopática (DP) diagnosticada por um médico de acordo com os critérios de diagnóstico da Sociedade de Distúrbios do Movimento (MDS), com início após os 40 anos.
- Regime de medicação antiparkinsoniana estável, incluindo terapia com levodopa, inalterado durante pelo menos 4 semanas antes e durante o ensaio.
- Estádios de Hoehn e Yahr (H&Y) 1,5 a 3 e capacidade de caminhar sem assistência.
- Ausência de demência, definida como pontuação no Montreal Cognitive Assessment (MoCA) ≥ 21.
Critérios de Exclusão:
- Qualquer contraindicação para ressonância magnética (RM) ou estimulação por interferência temporal transcraniana (TIS), incluindo claustrofobia, implantes metálicos na cabeça ou no coração, ou historial de terapia eletroconvulsiva.
- Uso atual de medicamentos antipsicóticos, antidepressivos ou outros que modulam a dopamina.
- Presença de condições ortopédicas que possam interferir com avaliações motoras, como osteoartrite ou cirurgia ortopédica recente (nos últimos 6 meses).
- Historial de doença psiquiátrica grave diagnosticada por um médico.
- Riscos cardiovasculares diagnosticados por um médico que possam contraindicar exercício ou participação no estudo.
- Historial prévio de cirurgia de estimulação cerebral profunda (DBS).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Grupo TIS
Os participantes neste braço receberão estimulação ativa de interferência temporal transcraniana direcionada ao globo pálido interno durante um período de intervenção de duas semanas.
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A estimulação por interferência temporal transcraniana (TIS) é uma técnica não invasiva de estimulação cerebral que fornece duas correntes alternadas de alta frequência através de elétrodos no couro cabeludo para gerar um campo de interferência de baixa frequência em regiões cerebrais profundas.
Neste estudo, a TIS tem como alvo o globo pálido interno (GPi) para modular a atividade neural em pessoas com doença de Parkinson.
Os participantes recebem 10 sessões de estimulação ao longo de duas semanas.
A condição de TIS simulada utiliza a mesma configuração, mas aplica correntes de baixa frequência sem gerar um padrão de interferência.
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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.
|
A estimulação por interferência temporal transcraniana (TIS) é uma técnica não invasiva de estimulação cerebral que fornece duas correntes alternadas de alta frequência através de elétrodos no couro cabeludo para gerar um campo de interferência de baixa frequência em regiões cerebrais profundas.
Neste estudo, a TIS tem como alvo o globo pálido interno (GPi) para modular a atividade neural em pessoas com doença de Parkinson.
Os participantes recebem 10 sessões de estimulação ao longo de duas semanas.
A condição de TIS simulada utiliza a mesma configuração, mas aplica correntes de baixa frequência sem gerar um padrão de interferência.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-I (MDS-UPDRS I) Score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline in the Home Diary Assessment of Motor States (Medication-ON Without Dyskinesia)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
29 de dezembro de 2025
Conclusão Primária (Real)
15 de abril de 2026
Conclusão do estudo (Real)
15 de abril de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
15 de novembro de 2025
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de dezembro de 2025
Primeira postagem (Real)
30 de dezembro de 2025
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 102772024RT146
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .