Transcranial Temporal Interference Stimulation Targeted of the Amygdala as an Intervention for Alcohol Use Disorder Patients

Официальное название

Exploring the Efficacy and Neural Mechanisms of Transcranial Temporal Interference Stimulation Modulating the Amygdala on Patients With Alcohol Use Disorder

Обзор

The purpose of this research is to investigate the efficacy of transcranial temporal interference stimulation (tTIS) targeting the amygdala in patients with alcohol use disorder.

Подробное описание

This study employs a randomized, double-blind design to investigate the emerging non-invasive deep brain stimulation modality of temporal interference stimulation (tTIS) targeted at the amygdala, aiming to validate the efficacy and feasibility of non-invasively modulating the amygdala for the treatment of patients with alcohol use disorder (AUD). During the intervention phase, all participants will be randomly assigned to receive either active stimulation or sham stimulation. The localization of the amygdala will be modeled based on individual brain imaging data for each participant. Clinical characteristics, electroencephalography (EEG) and magnetic resonance imaging (MRI) data will be collected from all patients at baseline and post-intervention. In addition, follow-up assessments of alcohol consumption will be conducted for all participants after the intervention.

Вмешательства

• Устройство tTIS on Amygdala, 10 Hz
  Through the transcranial electric stimulation device, the first pair of electrodes continuously outputs a current with a frequency of f1 = 2 kHz, while the second pair continuously outputs a current with a frequency of f2 = 2.010 kHz. According to the principle of time-domain coherence, an alternating electric field with a frequency of f2-f1 = 10 Hz can be generated in the target area. The optimal electrode position and current parameters are determined by using the individualized modeling. For
• Устройство tTIS on Amygdala, Sham
  The first pair of electrodes continuously outputs a current with a frequency of f1 = 2 kHz, while the second pair continuously outputs a current with a frequency of f2 = 2 kHz. The optimal electrode position and current parameters are determined by using the individualized modeling. For each participant, the current intensity was determined via electric field simulation to implement an individualized intervention protocol.

Первичные конечные точки

• Change of Craving assessed by Visual Analog Scale [Срок оценки: Reported by participants before and after intervention, as well as during the 1 and 4 weeks follow-up period.]

Вторичные конечные точки (10)

• Number of participants who relapse [Срок оценки: At 1 week, 2 weeks, and 4 weeks after participants' discharge from the hospital.]
• Depression status assessed by Patient Health Questionnaire-9(PHQ-9) [Срок оценки: Baseline and 7 days after intervention]
• Anxiety status assessed by Generalized Anxiety Disorder-7(GAD-7) [Срок оценки: Baseline and 7 days after intervention]
• Preference in natural/alcohol rewards assessed by a reward/alcohol choice preference E-prime paradigm [Срок оценки: Baseline and 7 days after intervention]
• Responses to negative reward prediction error assessed by a negative reward prediction error E-prime paradigm [Срок оценки: Baseline and 7 days after intervention]
• Emotional states assessed using the Depression Anxiety Stress Scales (DASS). [Срок оценки: Baseline and 7 days after intervention]
• levels of positive and negative affect assessed by Positive and Negative Affect Schedule (PANAS) [Срок оценки: Baseline and 7 days after intervention]
• perceived stress assessed by Perceived Stress Scale (PSS) [Срок оценки: Baseline and 7 days after intervention]
• Functional connectivity assessed by MRI [Срок оценки: Baseline and 7 days after intervention]
• Cognitive emotion regulation strategies assessed by Cognitive Emotion Regulation Questionnaire (CERQ） [Срок оценки: Baseline and 7 days after intervention]

Критерии участия

Критерии включения

• aged 18 to 60 years old;
• Meets the DSM-5 diagnostic criteria for alcohol use disorder;
• Normal or corrected normal vision and hearing;
• Able to cooperate in completing the questionnaire assessment and behavioral tests;
• No metal implantation in the head, no history of neurological problems or head injury.

Критерии исключения

• Suffering from severe cognitive dysfunction, such as a history of head trauma, cerebrovascular disease, epilepsy, etc., use of cognitive-promoting medications in the last 6 months;
• serious physical or neurological illness, a diagnosis of any other psychiatric disorder under DSM-5 criteria (except for nicotine use disorder); Other psychoactive substance abuse or dependence in the last 5 years (except nicotine).
• any contraindications to transcranial electrical stimulation.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Mental Health Center — Шанхай

Идентификаторы

NCT: NCT07472673 · MZhao-026 · 2021ZD0202105 · 82571704

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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