Идёт набор NCT07294924

Prediction of REsponse to Depression Interventions (Accelerated rTMS) Using Clinical and TD-fNIRS Measurements

— Наблюдательное Major Depressive Disorder (MDD) fNIRS

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: fNIRS measurement.
Кому может быть актуально: Состояния в реестре: Major Depressive Disorder (MDD), fNIRS. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

PREDICT-ACC: Prediction of REsponse to Depression Interventions (Accelerated rTMS) Using Clinical and TD-fNIRS Measurements

Обзор

This observational, longitudinal, multi-cohort study aims to evaluate functional brain activity in adults undergoing treatment for Major Depressive Disorder (MDD) at participating clinical sites. A separate cohort of healthy adults will be enrolled as a control group. All data collected in this study are for research purposes only and will not influence clinical decision-making or treatment plans. This study will use TD-fNIRS to measure hemodynamic brain responses at rest and/or during tasks in patients receiving accelerated transcranial magnetic stimulation (TMS). Imaging will occur at multiple timepoints (pre-treatment, post-treatment, and follow-ups). Healthy control participants will complete similar measurements at one visit, with the option for a follow-up visit. The primary objectives are to assess feasibility, characterize brain activity patterns, and explore potential biomarkers associated with treatment response.

Вмешательства

Другое fNIRS measurement
Kernel Flow is a non-invasive neuroimaging device that uses time-domain functional near-infrared spectroscopy (TD-fNIRS) to measure changes in cortical hemodynamics associated with brain activity.

Первичные конечные точки

TD-fNIRS Biomarkers of Treatment Response and Group Differences [Срок оценки: Baseline and 1-month after baseline]

Критерии участия

Inclusion Criteria for:

Accelerated TMS cohort

Adults aged 18-75 at the time of enrollment
Primary diagnosis of MDD as defined by the DSM-5
Determined by the clinic to be eligible for accelerated rTMS treatment and agrees to receive accelerated rTMS treatment
Agrees to start accelerated rTMS treatment in conjunction with study participation to capture baseline measurements
Has not received rTMS treatment in the past 1 month
Has not received SPRAVATO treatment in the past 1 month
Can speak and understand English
Ability to provide informed consent

Healthy controls cohort

Adults aged 18-75 at time of enrollment
Can speak and understand English
Ability to provide informed consent

Exclusion Criteria for:

All cohorts

Pregnant or may become pregnant during the treatment course
Unable or unwilling to wear the fNIRS headset
Has had electroconvulsive therapy (ECT) in the past 3 months
Major medical illnesses including neurological and psychiatric conditions such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, epilepsy, schizophrenia, or stroke.
Any other clinically significant medical condition that in the opinion of the clinician or study team, could affect patient safety, wellbeing, or the participant's ability to comply with study procedures.
Not an appropriate candidate for the study based on the discretion of the study investigator(s).

Healthy controls cohort only