Меню
Идёт набор NCT06919432

Efficacy of Triple-daily 15mA tACS on Adolescent NSSI

Без фазы С лечением Self-Injurious Behavior

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: Active-tACS, Sham-tACS.
Кому может быть актуально
Состояния в реестре: Self-Injurious Behavior. Базовые параметры: 12 лет — 21 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Efficacy of Triple-daily 15mA Transcranial Alternating Current Stimulation on Adolescent Non-suicidal Self-injury (NSSI): a Double-blind, Randomized, Sham-controlled Trial

Обзор

In order to assess the clinical efficacy of triple-daily 15mA-tACS stimulation by comparing the effects of active and sham tACS interventions on driving improvements in adolescent Nonsuicidal Self-Injury(NSSI), participants will be randomly assigned to either the active or sham tACS group. This trial consists of a 2-week intensified intervention phase (40 sessions), followed by a 4-week observation period. The key hypothesis is that triple-daily 15mA-tACS stimulation will enhance clinical recovery compared to sham stimulation.

Подробное описание

Recognizing the clinical shortcomings of traditional methods for adolescent NSSI, study objective is to establish evidence supporting the efficacy of a triple-daily 15mA-tACS stimulation regimen targeting the forehead and both mastoids. This intervention will be administered five days a week over a four-week treatment period, with the aim of eliciting substantial clinical improvements in adolescent NSSI compared to a sham intervention. On the first day of the intervention, participants will receive a tACS session, followed by triple-daily tACS sessions administered for 13 consecutive days. Following the completion of treatment, participants will undergo follow-up observations every 7 days for 4 weeks. EEG and ECG recordings will be obtained at baseline, on day 1 after the first session, at the end of the 2-week intervention period (after 40 sessions), and at the 6-week follow-up. Throughout the sessions, all evaluations will be conducted under standardized conditions.

Вмешательства

  • Устройство Active-tACS
    Participants were comfortably positioned on a lounge chair and received alternating current stimulation using an FDA-approved tACS device (Nexalin Technology, Inc., Houston, TX, USA). Electrodes were evenly placed across the forehead and mastoid regions. Trained nurses administered the tACS according to standardized protocols.
  • Устройство Sham-tACS
    The sham tACS device will resemble the active stimulation device in appearance, weight, size, color, and odor, ensuring indistinguishability for the patients. Throughout the entire intervention period, each participant will be allocated to the same tACS device, regardless of whether it delivers active or sham stimulation.

Первичные конечные точки

  • Change in total NSSI incidents during the 4-week follow-up period post-intervention [Срок оценки: 6 weeks]
  • Change in mean NSSI severity levels during the 4-week follow-up period post-intervention [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

  • Diagnosis of NSSI based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria section 3 diagnostic criteria.
  • Five or more NSSI episodes in the past year and at least one NSSI episode in the past month.
  • Age between 12 and 21 years.
  • Informed consent from parents or legal guardians.
  • Informed consent from participants aged 15 years and above.

Критерии исключения

  • Current or history of organic brain disorders or neurological disorders.
  • Elevated or imminent suicidal risk, as assessed by clinicians during routine screening.
  • Previous or current exposure to electroconvulsive therapy (ECT), modified ECT, TMS, transcranial direct current stimulation (tDCS), tACS, or other neurostimulation treatments.
  • Presence of cochlear implants, cardiac pacemakers, implanted devices, or metal in the brain.
  • Previous or current use of psychotropic medication.
  • Pregnancy or lactation.
  • Participation in another concurrent clinical trial.
  • Refusal to provide informed consent to participate in the trial.
  • Other circumstances deemed unsuitable for participation by researchers.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Shanghai Mental Health Center — Шанхай

Идентификаторы

NCT: NCT06919432 · 2024y1023

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗