Transcranial Direct Current Stimulation for Post-stroke Fatigue

Официальное название

Home-based Post-stroke Fatigue Treatment Using Transcranial Direct Current Stimulation (tDCS)

Обзор

The investigators hypothesize that delivery of anodal tDCS to the left frontal head region will reduce fatigue severity following stroke.

Подробное описание

The purpose of this study is to investigate transcranial direct current stimulation (tDCS) as a home-based non-pharmacologic intervention for post-stroke fatigue (PSF). Investigators will perform a double-blind, sham-controlled, randomized clinical trial with 24 subjects; 12 will receive sham stimulation and 12 will receive real stimulation. After a baseline assessment, the tDCS device will be applied for 20 minutes, once daily over the left dorsolateral prefrontal cortex (DLPFC), for a total of two weeks. Follow-up assessments with outcome metrics will be completed after the seventh and fourteenth sessions, and one-month following the start date (2 weeks post-treatment). Neuroimaging will be completed at baseline and post-treatment.

Вмешательства

• Устройство Real Soterix Mini-CT tDCS stimulator
  Real transcranial electrical stimulation at 2mA intensity will be delivered to the left dorsolateral prefrontal cortex, 20 minutes/day, 14-day duration.
• Устройство Sham Soterix Mini-CT tDCS stimulator
  Sham stimulation to the left dorsolateral prefrontal cortex, 20 minutes/day, 14-day duration. The device will ramp up and ramp down current delivery from 0 mA -2 mA - 0 mA over 30 seconds at the start of the 20-minute protocol with no active stimulation until the end of the 20 minutes, at which time the 30-second ramp up/ramp down will be repeated.

Первичные конечные точки

• Mean change from baseline Fatigue Severity Scale - 7 (FSS-7) [Срок оценки: Screening (-1 to -14 days), Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52))]

Вторичные конечные точки (10)

• Mean change from baseline Stroke Specific Quality Of Life scale (SS-QOL) [Срок оценки: Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)]
• Mean change from baseline Patient Health Questionnaire - 9 (PHQ-9) [Срок оценки: Screening (-1 to -14 days), Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)]
• Mean change from baseline Generalized Anxiety Disorder - 7 (GAD-7) [Срок оценки: Screening (-1 to -14 days), Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)]
• Mean change from baseline PROMIS-sleep disturbance [Срок оценки: Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)]
• Mean change from baseline Symbol Digit Modalities Test (SDMT) [Срок оценки: Baseline (Day 1), Post-Treatment (Day 14-21)]
• Mean change from baseline Test of Variables of Attention (T.O.V.A) [Срок оценки: Baseline (Day 1), Post-Treatment (Day 14-21)]
• Mean change from baseline Montreal cognitive assessment (MoCA) [Срок оценки: Baseline (Day 1), Post-Treatment (Day 14-21)]
• Mean Client Satisfaction Questionnaire - 8 (CSQ-8) [Срок оценки: During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)]
• Mean change from baseline Frenchay activities index [Срок оценки: Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)]
• Change in resting state brain functional connectivity. [Срок оценки: Baseline (Day 1), Post-treatment (Day 14-21)]

Критерии участия

Критерии включения

• Male or female patients aged >18 years
• Greater than 3 months from first hemorrhagic or ischemic stroke (subacute to chronic), confirmed through neuroimaging (CT or MRI).
• Fatigue severity score average >4 (severe fatigue)
• Willingness to remain stable on pharmacologic therapy through the duration of the study.
• Availability of a caregiver, family member, or friend to be present during the administration of the tDCS intervention.

Критерии исключения

• Metal in the head (except mouth) or implanted cranial or thoracic devices (i.e. pacemaker, DBS stimulator)
• History of seizure
• History of moderate to severe traumatic brain injury
• A score of 10 or more on the PHQ-9 or GAD-7 scale, suggestive of moderate to severe depression/anxiety.
• A score of less than 21 on the MoCA suggesting major neurocognitive disorder.
• Signs of skin rash, infection, or laceration in the supraorbital region where the tDCS will be applied.
• Inability to provide informed consent
• Other major neurological, medical, or psychiatric illnesses that could confound results in the opinion of the site investigator.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106 — New York

Идентификаторы

NCT: NCT05816603 · 22-11025409

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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