Remotely Supervised Home-based Transcranial Temporal Interference Stimulation on Motor Symptoms in Parkinson's Disease

Официальное название

Remotely Supervised Home-based Transcranial Temporal Interference Stimulation on Motor Symptoms in Parkinson's Disease: Protocol For a Double Blind Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if home-based temporal interference stimulation (TIS) works to improve motor symptoms in people with Parkinson's disease (PD). It will also learn about the safety of this treatment. The main questions it aims to answer are: 1. Does home-based TIS improve movement problems such as slow movement, stiffness, and walking difficulty? 2. Are the effects maintained after the treatment ends? 3. What medical problems (adverse events) occur during treatment? Researchers will compare active TIS to a sham treatment (a look-alike procedure that does not deliver active stimulation) to see if TIS works. Participants will: 1. Receive active TIS or sham stimulation once a day for 4 weeks at home under remote supervision 2. Visit the clinic at specific time points for movement assessments 3. Complete online questionnaires about symptoms and quality of life

Вмешательства

• Устройство Home-based Transcranial Temporal Interference Stimulation (HB-TIS)
  Transcranial temporal interference stimulation (TIS) is a noninvasive brain stimulation technique that delivers two high-frequency alternating currents through scalp electrodes to generate a low-frequency interference field in deep brain regions. In this study, TIS targets the internal globus pallidus (GPi) to modulate neural activity in people with Parkinson's disease. Participants will receive one stimulation session per day, seven days per week, for four weeks in a home-based setting under re

Первичные конечные точки

• Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) [Срок оценки: Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention]
• The time to complete 3-meter instrumented Timed Up and Go (iTUG) test [Срок оценки: Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention]

Вторичные конечные точки (12)

• The time to complete sit-to-stand and stand-to-sit transitions in 3m-iTUG [Срок оценки: Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.]
• Turning time during 3m-iTUG [Срок оценки: Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention]
• Response rate of MDS-UPDRS-III and gait speed [Срок оценки: Baseline, immediately after 1 and 4 weeks of intervention]
• MDS-UPDRS-III sub scores [Срок оценки: Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention]
• Geriatric Anxiety Inventory (GAI) [Срок оценки: Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention]
• Geriatric Depression Scale (GDS) [Срок оценки: Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention]
• Scales for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT) [Срок оценки: Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention]
• Montreal Cognitive Assessment (MOCA) [Срок оценки: Baseline, after 4 weeks of intervention]
• Trail Making Test (Part A/B) [Срок оценки: Baseline, after 4 weeks of intervention]
• The Digit Span Test evaluates (DST) [Срок оценки: Baseline, after 4 weeks of intervention]
• Parkinson's Disease Sleep Scale-2 (PDSS-II) [Срок оценки: Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention]
• Epworth Sleeping Scale (ESS) [Срок оценки: Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention]

Критерии участия

Критерии включения

• Diagnosis of Parkinson's disease according to established clinical criteria
• Mild-to-moderate disease severity, defined as Hoehn and Yahr stage 1.5-3;
• Age between 40 and 80 years;
• Stable anti-parkinsonian medication regimen;
• Ability to walk unaided for at least 2 minutes.

Критерии исключения

• contraindications to TIs (e.g., metal implantation, pacemakers, etc.);
• the use of DBS;
• significant cognitive impairment as defined by the diagnosis of Alzheimer's disease or dementia, or Montreal Cognitive Assessment (MoCA) total score<21, a recommended threshold for dementia in PD;
• diagnosis of other neurological conditions such as multiple sclerosis, previous stroke;
• report of severe lower-extremity arthritis, pain, or orthopedic problems significantly affecting gait;
• physician-diagnosis of schizophrenia or other psychiatric illness;
• an unwillingness to cooperate or participate in the study protocol. Eligible and interested participants will then be enrolled and complete baseline assessments before the randomization.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Shanghai University of Sport — Шанхай
• Shanghai University of Sport — Шанхай

Идентификаторы

NCT: NCT07518290 · 102772025RT234 · 11932013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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