The Efficiency of Transcranial Direct Current Stimulation in the Treatment of Anorexia Nervosa

Condition(s) studied

Investigational drug(s) / intervention(s)

tDCS: Patients will be receiving twice a day tDCS (applied current at 2mA) stimulation, for 3 weeks on working days (30 sessions in total) and each stimulation will last 25 minutes. The anode will be located on the left, while the cathode- on the right dorsolateral prefrontal area of scalp. The commercially available Soterix 1x1 tDCS mini-CT LTE device (model 1601-LTE) will be used for stimulation.

Placebo: Patients will be receiving twice a day sham stimulation, for 3 weeks on working days (30 sessions in total) and each stimulation will last 25 minutes. The anode will be located on the left, while the cathode- on the right dorsolateral prefrontal area of scalp. The commercially available Soterix 1x1 tDCS mini-CT LTE device (model 1601-LTE) will be used for stimulation.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in severity of eating disorder symptoms 1 — 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 severity of eating disorder symptoms 2 — 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 — 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 — 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 — 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 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 1 — 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 severity of depressive symptoms 2 — 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 — 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 attention and perceptiveness — The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
  To assess levels of attention Color connection test (CTT-1, CTT-2) and Test of attention and perceptiveness will be used.
• Change in intensity of intrusive thoughts — The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
  To assess intensity of intrusive thoughts CY-BOCS scale will be used
• Change in intensity of rumination — The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
  To assess intensity of rumination the Ruminance-Reflectivity Questionnaire will be used
• Change in visual memory — The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
  To assess visual memory test BENTON will be used. This test is used to test memory, visual perception and graphomotor skills. The examined person draws the presented patterns (10 pieces) from memory or redraws them, depending on the version and methods of the research carried out by the researcher.
• Change in body image self-esteem — The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
  To assess body image self-esteem Appearance Self-Rating Sheet (ASRS) will be used. Assessment of 25 dimensions related to your body - (different parts of your body). The patient receives a visualization of the body figure on the drawing and evaluates its individual elements. The test allows you to assess the importance of appearance for patients, the assessment of satisfaction with one's appearance and the satisfaction index. The SES self-assessment questionnaire will also be used
• Change in cognitive abilities 1 — The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
  To assess cognitive abilities Matching Familiar Figures Test (MFF)
• Change in cognitive abilities 2 — The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
  To assess cognitive abilities Verbal Fluency Test will be used.
• Change in self-esteem — The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
  The Rosenberg Self-Esteem Scale (SES) will be used. SES is a tool for assessing the level of general self-esteem - a relatively stable disposition understood as a conscious attitude (positive or negative) towards the Self
• Change in emotion regulation — 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 — 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 — 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 — 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 — 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 — 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.

Trial sites (1)

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