Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke

Официальное название

Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke (TRAINS): Neuromodulatory Intervention to Ameliorate Cognition After Stroke for Individuals At Risk for VCID.

Обзор

The purpose of this study is to determine whether a non-invasive brain stimulation technique, transcranial direct current stimulation (tDCS), combined with traditional cognitive therapy will improve cognitive function in patients with subacute stroke.

Подробное описание

This is a double-blind, sham-controlled study in which subjects with cognitive impairment after stroke will undergo neuropsychological testing before and after receiving 5 semi-consecutive daily sessions of real or sham transcranial direct current stimulation (tDCS) paired with cognitive therapy. Subjects will have experienced a stroke within 3 months of enrollment and will be undergoing inpatient rehabilitation at Penn Institute for Rehabilitation Medicine. Neuropsychological testing will be repeated immediately after completion of stimulation and 3-, 12- and 24- months following completion of treatment. The investigators will examine changes in cognitive performance induced by tDCS + cognitive therapy compared to sham tDCS + cognitive therapy. This study will combine knowledge gained from our behavioral, clinical and sociodemographic data in order to determine the relative degrees to which these properties predict whether persons with post-stroke cognitive impairment will respond to intervention.

Вмешательства

• Устройство tDCS
  tDCS is a type of non-invasive brain stimulation in which small electrical currents are applied to the scalp via 2 electrodes. During sham stimulation, the current, 2 mA, will be delivered for a short amount of time and then turn-off. To deliver the current, electrodes that are placed in saline soaked sponges. They will be attached to the left side of your head; they will be held in place with an elastic cap. For both real and sham stimulation the electrodes will be placed on the scalp. Most peo
• Устройство sham tDCS
  tDCS is a type of non-invasive brain stimulation in which small electrical currents are applied to the scalp via 2 electrodes. During sham stimulation, the current, 2 mA, will be delivered for a short amount of time and then turn-off. To deliver the current, electrodes that are placed in saline soaked sponges. They will be attached to the left side of your head; they will be held in place with an elastic cap. For both real and sham stimulation the electrodes will be placed on the scalp. Most peo
• Поведенческое Cognitive Therapy
  During both the treatment and the sham intervention, participants will undero cognitive therapy training by performing the NBack task. In this sequential letter memory exercise participants are presented with sequential stimuli in the form of a series of letters. For each new stimulus they are asked to indicate if the current stimulus matches the stimulus from 2 trials prior. This exercise stimulates cognitive demand in working memory, executive function and attention and is correlated with dors

Первичные конечные точки

• Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [Срок оценки: Baseline assessment prior to intervention; immediate post-intervention; 12 weeks (+/- 4 weeks) post-intervention; 12 months (+/- 4 weeks) post-intervention]

Критерии участия

Критерии включения

• Stroke that occurred within 4 weeks of the study
• Presence of cognitive impairment attributable to stroke
• Between the ages of 18 and 90
• Able to understand the nature of the study and give informed consent
• Able to follow simple commands as evidenced by NIHSS subtest 1C =0

Критерии исключения

• History of chronic, serious, or unstable neurologic illness other than stroke
• Current unstable medical illness(es)
• History of reoccurring seizures or epilepsy
• Current abuse of alcohol or drugs (prescription or otherwise)
• Active and severe psychiatric disorder
• Metallic objects in the face or head other than dental apparatus such as braces, fillings, and implants.
• Pregnancy

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

• Penn Medicine Rehabilitation — Philadelphia

Идентификаторы

NCT: NCT04897334 · 848469

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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