临床试验/NCT05814458

NCT05814458进行中（未招募）不适用

The Efficiency of Transcranial Direct Current Stimulation in the Treatment of Anorexia Nervosa - a Randomised, Double-blind Clinical Trial

Medical University of Lublin1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2022年9月1日最近更新: 2026年2月2日

适应症

干预措施

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Medical University of Lublin
入组人数: 40
试验地点: 1
主要终点: Change in severity of eating disorder symptoms 1

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The main goal of the study (a 3-week, randomized, double-blind, and placebo-controlled study) is to determine the effect of Transcranial Direct Current Stimulation (tDCS) on the mental state and advances in nutritional rehabilitation in patients with AN. The primary hypothesis assumes that tDCS will reduce the symptoms of depression, improve cognition functions and it will have a positive effect on the reduction of restriction related to body weight and diet.

详细描述

The aim of the study is to assess the effect of tDCS stimulation on psychological and biological factors in patient suffering for AN with particular attention to the safety of such additional therapy. Transcranial direct current stimulation (tDCS) is a non-invasive and currently considered safe method of neurostimulation. It is based on the use of direct current of very low intensity, up to 2000uA-2mA, and supplying it to the brain through electrodes placed on the scalp. In this way, the polarity of the cell membranes of neurons is induced, and this influences changes in the cortical excitation of the brain.

Results confirming the efficacy of such a therapeutic approach would provide support for the introduction of brain stimulations as a valuable part of treatment in psychiatric wards but also as a part of home-based treatment.

The protocol was developed by a multidisciplinary researcher team of a psychiatrist, psychologist, psychotherapist and nutritionists. Thanks to this, it is possible to evaluate the progress taking place in various fields.

To the best of our knowledge, this will be the first intervention study assessing the efficacy of tDCS in AN taking into account not only psychological tests, but also biochemical markers (including levels of neurotrophins) or the electrical activity of the brain.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Single (Outcomes Assessor)

入排标准

年龄范围: 10 Years 至 30 Years（Child, Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Signed written Informed Consent Form,
•Patients aged 10-30 years old,
•Meet the DSM-5 criteria for AN,
•Body mass index (BMI) ≤ 17,5 kg/m2,
•A willingness and motivation to follow the study protocol.

排除标准

•Not giving Informed, Written Consent
•Diagnosis of neurological diseases, as epilepsy;
•Contraindications to tDCS, ie. pacemakers, metal parts around the head;
•Psychiatric comorbidities (except specific personality disorder) including mental retardation, organic brain dysfunction, or addiction (except nicotine and caffeine);
•Pregnancy or pregnancy planning;
•Changes in psychopharmacotherapy during hospitalization

研究组 & 干预措施

tDCS group

Active Comparator

The tDCS group will receive the active brain stimulation.

干预措施: tDCS (Device)

Placebo group

Sham Comparator

The placebo group will receive the sham brain stimulation.

干预措施: Placebo (Device)

结局指标

主要结局

Change in severity of eating disorder symptoms 1

时间窗: The test will be performed four times: Before stimulation, baseline (V1), immediately after stimulation (V2) two weeks after the intervention (V3), and two months after the intervention (V4)

The severity of symptoms will be assessed with Eating Attitudes Test (EAT-26)

Change in assessment of stress levels

The severity of stress will be assessed with Perceived Stress Scale (PSS-10). This test consists 10 questions and is used to measure stress based on subjective feelings related to problems and personal events, behavior, coping with stress.

Change in severity of depressive symptoms 2

时间窗: The tests will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2), and two months after the intervention (V4)

Severity of depressive symptoms will be assessed with Questionnaire for the Diagnosis of Depression in Children and Adolescents (CDI2).

Change in meta-cognition

时间窗: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2), and two months after the intervention (V4)

To assess metacognitive abilities Meta-Cognition Questionnaire (MCQ-A) will be used. Reliable and valid instrument for measuring meta-cognitive beliefs in adolescents (12-18 lat). The MCQ-A assesses the severity of dysfunctional meta-cognitive beliefs in adolescents (12-18) that affect their daily functioning. The first and second subscales measures "positive and negative beliefs about worry," Subscale 3 measures "cognitive confidence," Subscale 4 measures "beliefs about superstition, punishment and responsibility". Finally, subscale 5 measures "cognitive self-consciousness,".

Change in emotion regulation

时间窗: The test will be performed three times: at baseline (V1), immediately after stimulation (V2), and 2 months after stimulation (V4).

A shortened 16-item version of a questionnaire designed for the rapid assessment of difficulties in emotion regulation Difficulties in Emotion Regulation Scale DERS-16 wil be performed. The scale measures five domains, such as lack of emotional acceptance, impulsivity, and difficulties with goal-directed behavior, using a 5-point scale.

Change in autistic traits

时间窗: The test will be administered three times: at baseline (V1), immediately after stimulation (V2), and 2 months after stimulation (V4).

The Autism Spectrum Quotient (AQ) is a self-administered questionnaire used to measure the degree to which a person shows autistic traits.

Change in mental states

时间窗: The test will be administered three times: at baseline (V1), immediately after stimulation (V2), and 2 months after stimulation (V4).

The questionnaire Mentalization Scale (MentS) is used for a rapid assessment of the capacity to reflect on mental states (emotions, intentions, and beliefs).

Change in body-related conversations

时间窗: The test will be peformed three times: at baseline (V1), immediately after stimulation (V2), and 2 months after stimulation (V4).

Family Talk Questionnaire Fat Talk refers to negative, body-related conversations between girls or young women.

Change in cognitive functions

时间窗: The test will be performed twice: at baseline (V1), immediately after stimulation (V2)

A neuropsychological diagnostic tool Rey-Osterrieth Complex Figure used to assess visuospatial abilities, visual memory, and executive functions (planning and organization).

Change in anxiety level

时间窗: The test will be performed three times: at baseline (V1), immediately after stimulation (V2), and 2 months after stimulation (V4).

The STAI (State-Trait Anxiety Inventory) is a psychological tool used to measure anxiety as both a state (a temporary feeling of tension) and a trait (a stable personality disposition). It consists of two subscales (X-1 and X-2, or Y-1 and Y-2), each containing 20 questions, with scores ranging from 20 to 80 points.

Change in severity of eating disorder symptoms 1

时间窗: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)

The severity of symptoms will be assessed with Eating Attitudes Test (EAT-26)

Change in severity of eating disorder symptoms 2

时间窗: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)

The severity of symptoms will be assessed with Eating Disorder Examination Questionnaire (EDE-Q 6.0).

Change in eating habits and opinions about food and nutrition

时间窗: The test will be performed two times: Before stimulation, baseline (V1) and two weeks after intervention (V3)

To evaluate changes in eating habits and opinions about food and nutrition the Questionnaire of Eating Behaviours (QEB) will be used. It is a qualitative questionnaire designed to study eating habits and opinions about food and nutrition. The first part of the questionnaire covers the frequency of consumption of selected products, the frequency of eating meals and their typical composition. In the second part of the questionnaire, there are 26 statements about food and nutrition, which enable the assessment of the level of nutritional knowledge of the respondents.

Change in food intake variety

时间窗: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)

Food Intake Variety will be assessed with The Variety Food Consumption Questionnaire. It is a qualitative food consumption frequency questionnaire. It is a simple tool to collect information on the consumption of (yes / no) 63 assortment groups of products.

Change in assessment of stress levels

时间窗: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)

Change in severity of depressive symptoms 2

时间窗: The tests will be performed twice: Before stimulation, baseline (V1) and immediately after stimulation (V2)

Severity of depressive symptoms will be assessed with Questionnaire for the Diagnosis of Depression in Children and Adolescents (CDI2).

Change in severity of depressive symptoms 1

时间窗: The tests will be performed twice: Before stimulation, baseline (V1) and immediately after stimulation (V2)

Severity of depressive symptoms will be assessed with Beck's Depression Inventory (BDI)

Change in meta-cognition