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Идёт набор NCT07094789

Focused Ultrasound Neuromodulation in Patients With Treatment-Resistant Depression

Без фазы С лечением Treatment-Resistant Depression Treatment-resistant Depression (TRD)

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: Next Generation Dome Helmet (NGDH).
Кому может быть актуально
Состояния в реестре: Treatment-Resistant Depression, Treatment-resistant Depression (TRD). Базовые параметры: 18 лет — 65 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
Канада
Следующий шаг
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Официальное название

Assessment of Safety and Feasibility of Focused Ultrasound Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment-Resistant Depression

Обзор

The goal of this clinical trial is to evaluate the safety and initial effectiveness of Magnetic Resonance-guided focused ultrasound neuromodulation using the Next Generation Dome Helmet (NGDH) device in patients with treatment-resistant depression. This is a prospective, single-arm, non-randomized study. Participants will: * Undergo two focused ultrasound treatment sessions targeting nodes of the cortical-striatal-thalamic circuit (CSTC) , spaced four weeks apart. * Return for follow-up visits at 24 hours, 2 weeks, and 4 weeks after each treatment session, during which clinical scales and imaging assessments will be conducted to monitor safety and clinical effects.

Подробное описание

A total of 20 participants with treatment-resistant depression will be enrolled and treated in this study. Participants will be recruited through local psychiatric practices, referrals from participating institutions, and external referrals, including both physician and self-referrals.

Eligibility will be assessed during a dedicated screening appointment conducted by the study coordinator in collaboration with a study-affiliated physician. The anticipated enrollment period is approximately two years, beginning from the date of first patient enrollment to the enrollment of the final participant.

Вмешательства

  • Устройство Next Generation Dome Helmet (NGDH)
    Participants will receive two sessions of Magnetic Resonance-guided focused ultrasound neuromodulation, spaced four weeks apart, using the Next Generation Dome Helmet device. Treatments will target regions within the CSTC circuit identified by advanced MRI scans. Each session will include pre-treatment assessments, precise sonications of deep brain structures, real-time safety monitoring, and post-treatment imaging.

Первичные конечные точки

  • Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients with Treatment-Resistant Depression [Срок оценки: Assessments will be conducted at the baseline visit, 24 hours after the first treatment, 2 weeks after the first treatment, 24 hours after the second treatment, and at 2 and 4 weeks following the second treatment.]
Вторичные конечные точки (1)
  • Clinical Efficacy - Change in Depressive Symptoms measured by Hamilton Depression Rating Scale (HAMD-17) [Срок оценки: Assessed at 2 weeks after first treatment and 2 and 4 weeks after second treatment.]

Критерии участия

Критерии включения

  • Deemed to have the capacity to provide informed consent.
  • Aged between 18 and 65 years.
  • Diagnosis of major depressive disorder (MDD) according to DSM-5 criteria.
  • Total score >20 on the Hamilton Depression Rating Scale (HAMD-17).
  • On a stable regimen of psychiatric medications for at least 30 days prior to enrollment.
  • Documented previous trial of at least two first-line antidepressant agents at adequate dose and duration, as assessed by two psychiatrists.
  • Documented previous trial of cognitive behavioral therapy (CBT) or psychotherapy for MDD, sustained for at least 6 weeks.

Критерии исключения

  • Pregnant or intending to become pregnant during the study period.
  • Diagnosis of a substance use disorder (excluding cannabis or nicotine) of moderate severity or greater, or when the substance is the primary focus of treatment, based on DSM-5 criteria.
  • Known active seizure disorder, significant head injury with an imaging-verified lesion
  • Unstable medical illness.
  • Not eligible for 3-Tesla MRI (i.e. MRI-incompatible pacemaker)
  • Inability to reliably attend required screening, treatment, or follow-up appointments.
  • Severe claustrophobia, as identified by the participant, that would prevent completion of MRI procedures.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • Sunnybrook Health Sciences Centre — Toronto

Идентификаторы

NCT: NCT07094789 · 6702

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗