Clinical trial NCT05814458: The Efficiency of Transcranial Direct Current Stimulation in the Treatment of Anorexia Nervosa
Official title: The Efficiency of Transcranial Direct Current Stimulation in the Treatment of Anorexia Nervosa - a Randomised, Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Anorexia Nervosa
Brain stimulation
Eating disorders
Left dorsolateral prefrontal cortex
Transcranial direct current stimulation
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Signed written Informed Consent Form,
* Patients aged 13-25 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in severity of eating disorder symptoms 1
timeFrame: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
measure: Change in severity of eating disorder symptoms 2
timeFrame: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
measure: Change in eating habits and opinions about food and nutrition
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and two weeks after intervention (V3)
measure: Change in food intake variety
timeFrame: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
measure: Change in assessment of stress levels
timeFrame: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
measure: Change in severity of depressive symptoms 1
timeFrame: The tests will be performed twice: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Change in severity of depressive symptoms 2
timeFrame: The tests will be performed twice: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Change in meta-cognition
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Change in attention and perceptiveness
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Change in intensity of intrusive thoughts
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Change in intensity of rumination
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Change in visual memory
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Change in body image self-esteem
timeFrame: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
measure: Change in cognitive abilities 1
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Change in cognitive abilities 2
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Secondary outcomes:
measure: Change in electrolyte levels
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Change in morphotic elements 1
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Change in morphotic elements 2
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Change in morphotic elements 3
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Change in morphotic elements 4
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Change in morphotic elements 5
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Change in morphotic elements 6
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Change in morphotic elements 7
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Change in morphotic elements 8
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Metabolic changes 1
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Metabolic changes 2
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Neurophysiologic changes 1
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Change in neurotrophin levels
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Change in food intake regulators:
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
measure: Body composition changes 1
timeFrame: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
measure: Body composition changes 2
timeFrame: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
measure: Body composition changes 3
timeFrame: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
measure: Body composition changes 4
timeFrame: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
measure: Changes in HPA axis biomarker
timeFrame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: Ist Department of Psychiatry, Psychotherapy and Early Intervention
Study officials:
affiliation: 1st Department of Psychiatry, Psychotherapy and Early Intervention, Medical University of Lublin
name: Hanna Karakuła-Juchnowicz, Prof.
role: STUDY_DIRECTOR
References: