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Набира участници Фаза 2 NCT05584124

Repetitive Transcranial Magnetic Stimulation, a Form of Non-invasive Brain Stimulation, as a Possible Treatment for Post-stroke Fatigue.

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Stroke Stroke, Chronic Fatigue

Спонсор: VA Office of Research and Development

Налично на: БГ
Обобщение
This experimental trial is investigating the use of magnetic stimulation of the brain as a possible treatment for post-stroke fatigue in people who have had a stroke more than six months prior to enrolling. Fatigue is a common condition after a stroke and can negatively impact an individual's ability to perform desired social and physical activities. Magnetic stimulation of the brain has been shown to improve signs and symptoms of related psychological (e.g., depression) conditions. Participants in this trial will receive a type of magnetic stimulation called repetitive transcranial magnetic stimulation, or rTMS. The investigators will measure feelings of fatigue and other clinical characteristics related to mood and cognition before and after participants receive rTMS.
Описание
The PI for this trial transferred to the Atlanta VA Medical Center in Feb 2026. As a result, the trial was suspended at the original site and moved to the Atlanta area. Additional changes accompanying the site transfer include removing one arm of the study (an active comparator), leaving two arms: one with the active treatment and the other with a sham treatment. Eligibility criteria were also updated to be more ecologically relevant. Ethical approvals for the new site, Atlanta, were provided by the Emory University IRB.
Кой може да участва
Inclusion Criteria: * 34 - 80 years of age * more than 6 months post-stroke * Clinically present fatigue Exclusion Criteria: * Contraindications to MRI/TMS/rTMS (e.g. implanted metal within the head, history of seizures) * Inability to follow simple three-step instructions * Diagnosed comorbid neurological conditions (e.g. multiple sclerosis, Parkinson's disease, moderate/severe TBI) * Pregnancy * strokes within stimulation sites * Pregnancy * Severe hypertension (resting SBP \> 200, DBP \> 120)
Интервенции
High frequency repetitive transcranial magnetic stimulation
DEVICE
Sham repetitive transcranial magnetic stimulation
DEVICE
Места на провеждане 1
САЩ (1)
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur , Georgia
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
34 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
10.04.2023
Крайна дата
29.10.2027
Регистрационен номер
NCT05584124
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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