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

NCT05814458 | Active Not Recruiting

• 1 other identifier: KE-0254/24/01/2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anorexia Nervosa

Keywords

Anorexia Nervosa; Brain stimulation; Eating disorders; Left dorsolateral prefrontal cortex; Transcranial direct current stimulation

Outcome Measures

Primary Outcomes (22)

• Change in severity of eating disorder symptoms 1

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

  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)

• Change in severity of eating disorder symptoms 2

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

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

• Change in eating habits and opinions about food and nutrition

  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.

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

• Change in food intake variety

  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.

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

• 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.

  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)

• Change in severity of depressive symptoms 1

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

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

• Change in severity of depressive symptoms 2

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

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

• Change in meta-cognition

  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,".

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

• Change in attention and perceptiveness

  To assess levels of attention Color connection test (CTT-1, CTT-2) and Test of attention and perceptiveness will be used.

  The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)

• Change in intensity of intrusive thoughts

  To assess intensity of intrusive thoughts CY-BOCS scale will be used

  The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)

• Change in intensity of rumination

  To assess intensity of rumination the Ruminance-Reflectivity Questionnaire will be used

  The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)

• Change in visual memory

  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.

  The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)

• Change in body image self-esteem

  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

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

• Change in cognitive abilities 1

  To assess cognitive abilities Matching Familiar Figures Test (MFF)

  The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)

• Change in cognitive abilities 2

  To assess cognitive abilities Verbal Fluency Test will be used.

  The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)

• Change in self-esteem

  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

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

• Change in emotion regulation

  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.

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

• Change in autistic traits

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

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

• Change in mental states

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

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

• Change in body-related conversations

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

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

• Change in cognitive functions

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

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

• Change in anxiety level

  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.

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

Secondary Outcomes (26)

• Change in electrolyte levels

  The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)

• Change in morphotic elements 1

  The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)

• Change in morphotic elements 2

  The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)

• Change in morphotic elements 3

  The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)

• Change in morphotic elements 4

  The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)

Study Arms (2)

tDCS group

ACTIVE COMPARATOR

The tDCS group will receive the active brain stimulation.

Device: tDCS

Placebo group

SHAM COMPARATOR

The placebo group will receive the sham brain stimulation.

Device: Placebo

Interventions

tDCS DEVICE

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.

tDCS group

Placebo DEVICE

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.

Placebo group

Eligibility Criteria

• Age: 10 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lublin: lead

Study Sites (1)

Ist Department of Psychiatry, Psychotherapy and Early Intervention

Lublin, Lublin Voivodeship, 20-439, Poland

Location

Related Publications (1)

• Rzad Z, Rog J, Kajka N, Szewczyk P, Krukow P, Karakula-Juchnowicz H. The efficacy of transcranial direct current stimulation in the treatment of anorexia nervosa: a randomized double-blind clinical trial. Front Psychiatry. 2024 May 2;15:1284675. doi: 10.3389/fpsyt.2024.1284675. eCollection 2024.

  PMID: 38757134 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa; Feeding and Eating Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Hanna Karakuła-Juchnowicz, Prof.

  1st Department of Psychiatry, Psychotherapy and Early Intervention, Medical University of Lublin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: April 14, 2023
• Study Start: September 1, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

PL (1)