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

Medical University of Lublin

Status: Active, not recruiting

Conditions: Anorexia Nervosa

Treatments: Device: tDCS; Device: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05814458

KE-0254/24/01/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 10 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

tDCS group

Active Comparator group

Description:

The tDCS group will receive the active brain stimulation.

Treatment:

Device: tDCS

Placebo group

Sham Comparator group

Description:

The placebo group will receive the sham brain stimulation.

Treatment:

Device: Placebo