Stimulating After Recovery From Traumatic Brain Injury

Обзор

This is a preliminary, prospective interventional study to investigate the feasibility of using transcutaneous alternating current stimulation (TACS) after a traumatic brain injury (TBI) to improve cognitive function and decision-making.

Подробное описание

All participants engaged in the study will participate once weekly for six weeks at Hennepin Healthcare Systems, Inc. (HHS). Each participant will be randomized into the block design of sham or tACS during the first three appointments or the last three appointments. While participating, both the tACS will be applied in accordance with the manufacturer's suggested use. Participants will complete computer-based tasks, while taking part in either the sham or tACS stimulation. The study is investigating the use of neuromodulation after Traumatic Brain Injury (TBI) for improved cognitive function.

Вмешательства

• Комбинированный продукт External non-invasive stimulation
  The participants are randomized into the block design of sham or tACS during the first three appointments or the last three appointments. Eye tracking will be used to test the predominant focus of decisions during the gaze phase on costs or difficulty levels during the COGED. The study is investigating the use of neuromodulation after TBI for improved cognitive function.
• Поведенческое COGED
  The COGED task consists of the classic N-back task of working memory-based decision making, followed by a valuation phase. The N-back phase of the task allows calculation of cognitive performance of a working memory task. During valuation, participants receive titrating offers of differing amounts of money to perform different difficulty levels of the N-back. The result is an effort discounting curve used to measure the individual effort cost. Effort discounting curves show the perceived cogniti

Первичные конечные точки

• Feasibility of using non-invasive stimulation to improve Cognitive Flexibility after TBI [Срок оценки: 3 years]

Критерии участия

Критерии включения

• Adults 18 years and older
• Diagnosis of a mild to moderate TBI (GCS > 8 on admission)
• Able to perform a computerized assessment
• Willing to attend all scheduled appointments
• Able to undergo the informed consent process

Healthy participants:

• Adults 18 years and older
• Able to perform a computerized assessment
• Willing to attend all scheduled appointments
• Able to undergo the informed consent process

Критерии исключения

• Open wound on scalp
• Severe TBI diagnosis or GCS of less than 8 on admission
• Non-English speaking
• Incarcerated
• Implanted defibrillator or pacemaker
• Visual impairment that hinders ability to complete computerized assessments

Healthy subject exclusion criteria:

• Less than 18 years of age
• Open wound on scalp
• TBI diagnosis
• Non-English speaking
• Incarcerated
• Implanted defibrillator or pacemaker
• Visual impairment that hinders ability to complete computerized assessments

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Hennepin County Medical Center — Minneapolis

Идентификаторы

NCT: NCT05327829 · IRB-FY2023-678

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗