Testing Personalized High-Definition Transcranial Direct Current Stimulation (HD-tDCS) as a Treatment of Posterior Cortical Atrophy

Официальное название

Testing Personalized High Definition Transcranial Direct Current Stimulation (HD-tDCS) as a Treatment of Posterior Cortical Atrophy

Обзор

This study is being completed to learn if high-definition transcranial direct current stimulation (HD-tDCS) has an effect on visual and thinking abilities in persons with posterior cortical atrophy (PCA). Participants will be randomized to receive real or sham HD-tDCS (8 sessions over 4 days). Following the randomized treatment, participants will have optional open-label phase with real HD-tDCS up to 26 weeks and other possible testing.

Вмешательства

• Устройство HD-tDCS sessions
  This project translates decades of observational neuroimaging research into a biologically plausible stimulation target (i.e., DAN) and uses functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) to plan personalized brain stimulation and to ensure target engagement. When available; those not MRI compatible will receive a standard montage with per channel amplitudes of up to 5 milliamperes (mA) or a montage derived from other imaging methods. Participants will receiv
• Устройство Sham HD-tDCS sessions
  Participants will receive 4 days of sham HD-tDCS sessions in person. During these sessions participants will have electrodes placed on different areas of the head and held in place with headgear. Participants may also have memory and thinking tests during and after the sessions as well as questionnaires about the experience. Additionally, on the fourth day participants may have repeat immersive virtual reality (iVR) as well as other study activities.
• Устройство HD-tDCS sessions - Open-label (after randomized treatment)
  Optional 26 weeks of additional HD-tDCS sessions. Participants can complete up to 5 days per week, but most people will complete about 3 days per week. The study team may also collect audio recordings of these sessions. Participants can complete this in person or at-home via using a secure, HIPAA-compliant videoconferencing with the supervision of a research staff member. Participant's that decide to complete the additional sessions at home, a research staff member will train a study partner dur

Первичные конечные точки

• Change in network connectivity measured via fMRI [Срок оценки: Baseline and Day 5 (after 4 days of HD-tDCS)]
• Measure of form coherence [Срок оценки: Baseline and at end of study intervention (up to 6 months)]
• Long-term change in network connectivity via fMRI [Срок оценки: Baseline and end of study intervention (up to 6 months)]
• Measures of motion tasks [Срок оценки: Baseline and at end of study intervention (up to 6 months)]

Вторичные конечные точки (10)

• Measures of motion tasks [Срок оценки: Baseline and day 5 (after 4 days of HD-tDCS)]
• Measure of form coherence tasks [Срок оценки: Baseline and day 5 (after 4 days of HD-tDCS)]
• Eye tracking - Number of fixations [Срок оценки: Baseline and at end of study intervention (up to 6 months)]
• Eye tracking - Number of fixations [Срок оценки: Baseline and day 5 (after 4 days of HD-tDCS)]
• Self-ratings of cognitive change using the Posterior Cortical Atrophy Questionnaire (PCA-Q) [Срок оценки: Baseline and day 5 (after 4 days of HD-tDCS)]
• Self-ratings of cognitive change using the Posterior Cortical Atrophy Questionnaire (PCA-Q) [Срок оценки: Baseline and at end of study intervention (up to 6 months)]
• Immersive virtual reality (IVR) path length [Срок оценки: Baseline and at end of study intervention (up to 6 months)]
• functional near infrared spectroscopy (fNIRS) - Activation magnitude of DAN (processed) [Срок оценки: Baseline and at end of study intervention (up to 6 months)]
• Partner rating of cognitive change using the PCA-Q [Срок оценки: Baseline and day 5 (after 4 days of HD-tDCS)]
• Partner rating of cognitive change using the PCA-Q [Срок оценки: Baseline and at end of study intervention (up to 6 months)]

Критерии участия

Критерии включения

• Diagnosis or symptoms consistent with PCA
• Fluent in English
• HD-tDCS compatible
• Stable on relevant medications for at least approximately 4 weeks prior to study enrollment
• If completing any additional, optional, long-term study visits in a remote location (i.e., not our office), a study partner is required in order to administer HD-tDCS. Those choosing to return to our office may have, but are not required to have, a study partner.

Критерии исключения

• Other relevant neurological disease (e.g., epilepsy) or injuries (e.g., large vessel stroke, moderate-severe traumatic brain injury) viewed as primary to deficits since these could interfere with etiologic considerations and confound study results
• Active, relevant psychiatric conditions (e.g., bipolar disorder, schizophrenia) since the symptoms of these conditions may confound study participation.
• A recent (e.g., within the past 2 years) significant history of, or current, alcohol or drug abuse/dependence. Remote history of abuse/dependence is not exclusionary as long as it is not considered to be the primary etiology for visuospatial deficits.
• Women that are lactating/breastfeeding, pregnant, or may potentially be pregnant will be excluded from the study.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT07191327 · HUM00268033

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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