Home Transcranial Direct Current Stimulation (tDCS) to Enhance Functional Recovery

Официальное название

Enhancing Functional Recovery With Home-based Transcranial Direct Current Stimulation (tDCS) in Patients With Stroke, Neurodegeneration and Brain Tumors

Обзор

The purpose of this study is to assess the feasibility of home-based Transcranial Direct Current Stimulation (tDCS) combined with a home activity based therapy program in patients with stroke, brain tumors or neurodegenerative conditions and to assess the efficacy of home-based tDCS combined with a home activity-based therapy program as an intervention to treat cognitive-linguistic impairments related to stroke, brain tumors, or neurodegenerative conditions and improve quality of life.

Вмешательства

• Устройство Soterix® tDCS - Home treatment
  Participants will receive transcranial direct current stimulation (tDCS) via the Soterix device at an intensity of 2 mA for 20 minutes per session, with slow ramp-up and ramp-down of the current. Each participant will be asked to perform tDCS on weekdays for two-weeks (10 sessions total) or every other weekday for four weeks (12 sessions). The research team will decide on a number of therapy sessions depending on the patient's baseline condition and tolerance. Patients who receive 10 sessions o
• Поведенческое Cognitive-linguistic therapy
  Participants will be instructed to perform home activity based cognitive-linguistic task-based exercises. Each participant will be asked to perform tDCS concurrently with individualized activity based cognitive-linguistic therapy on weekdays for two-weeks (10 sessions total) or every other weekday for four weeks (12 sessions)
• Устройство Soterix® tDCS - Lab treatment
  Participants will receive transcranial direct current stimulation (tDCS) in person, via the same Soterix device the home based participants will use at an intensity of 2 mA for 20 minutes per session, with slow ramp-up and ramp-down of the current. They will undergo 12 sessions over four weeks.

Первичные конечные точки

• For patients with post-stroke cognitive impairment--Stricker Learning Span and Symbols Test [Срок оценки: Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks]
• For patients with post-stroke language impairment--Mayo-developed web-based language [Срок оценки: Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks]

Вторичные конечные точки (5)

• For patients with post-stroke language impairment--Western Aphasia Battery-Revised Bedside Version [Срок оценки: Baseline, 12 weeks, 24 weeks]
• Change in Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F) [Срок оценки: Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks]
• Change in Epworth Sleepiness Scale (ESS) [Срок оценки: Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks]
• Karolinska Sleepiness Scale (KSS) [Срок оценки: 10 minutes before and after each treatment session]
• Communicative Participation Item Bank [Срок оценки: Baseline, 12 weeks, 24 weeks]

Критерии участия

Критерии включения

• At least 3 months after ischemic/hemorrhagic/anoxic stroke or 3 months after completion of cranial radiation or cranial surgery for treatment of primary or metastatic intracranial tumors or neurodegenerative conditions include, but are not limited to, primary progressive aphasia, corticobasal syndrome, progressive supranuclear palsy, Parkinson's disease, and Alzheimer's disease dementia.
• Expected survival >6 months
• Functional impairment in the domains of language and/or cognition affecting quality of life determined by PI.
• Have a legally authorized representative who is able to sign on their behalf in unable to consent for themselves (ex., individuals with aphasia).
• Have a legally authorized representative who is able to sign on their behalf in unable to consent for themselves (ex., individuals with aphasia).

Критерии исключения

• Pregnancy
• Contraindication to tDCS, including metallic implanted objects.
• Medical instability or inability to cooperate during the study as assessed by the treating physician to participate in the study.
• Individuals with epilepsy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT07091396 · 24-006350

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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