Vibrotactile Coordinated Reset (vCR) for the Treatment of Advanced Parkinson's Disease Patients Who Have Previously Received vCR Stimulation

Обзор

The purpose of this study is to test the efficacy of vibrotactile coordinated reset(vCR) stimulation on human subject participants with advanced stage Parkinson's Disease who have previously received vCR therapy.

Вмешательства

• Устройство Vibrotactile coordinated reset (vCR)
  Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. A specific pattern of vibration to each fingertip is delivered which theoretically disrupts abnormal synchrony in the brain

Первичные конечные точки

• Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) off medication [Срок оценки: Baseline, 3Months,6 Months, 9 Months 12 Months, 18 Months, 24 Months]

Вторичные конечные точки (11)

• Levodopa equivalent daily dose (LEDD) daily change from baseline to 24 months [Срок оценки: 24 months]
• Parkinson's disease quality of life questionnaire-39 (PDQ-39) [Срок оценки: 24 months]
• Freezing of Gait Questionnaire (FOG) change [Срок оценки: 24 months]
• Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change [Срок оценки: 24 months]
• Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2 [Срок оценки: 24 months]
• Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4 change [Срок оценки: 24 months]
• Communicative Participation Item Bank (CPIB; Short Form) [Срок оценки: 24 months]
• Voice Handicap Index (VHI-10) [Срок оценки: 24 months]
• Spontaneous Electroencephalography beta band power change [Срок оценки: 24 months]
• Parkinson's disease cognitive functional rating scale (PD-CFRS) [Срок оценки: 24 months]
• Device calibration [Срок оценки: 24 months]

Критерии участия

Критерии включения

• Any adult age 18 and older
• Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to 4
• Fluent in English
• If patient is on medication that affects brain function or alters Electroencephalography (EEG) activity, the patient must feel comfortable going off this medication prior to EEG recording
• Appropriate social support if required during an off state.
• Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes.
• Feels comfortable going off Parkinson's Disease(PD) related medication during in person study visits
• Lives in the United States
• Having previously been enrolled in a vCR pilot study

Критерии исключения

• Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies
• Any current drug or alcohol abuse.
• Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
• Pregnancy, breast-feeding or wanting to become pregnant
• Physical limitations unrelated to PD that would affect motor ratings
• Craniotomy
• Brain surgery
• Patient is unable to communicate properly with staff (i.e., severe speech problems)
• Excessive drooling
• A type of hairstyle that would impede the use of an EEG cap
• Sensory abnormalities of the fingertips
• Patient is taking a medication that may cause significant withdrawal effects.
• Presence or diagnosis of Essential Tremor, psychogenetic tremor, functional tremor and any other non- pathological or non-Parkinsonian tremors

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06559098 · 71579

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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