NCT05814458

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Medical University of Lublin · Academic / Other
• Sex: Female
• Age: 10 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anorexia Nervosa

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2023-04-14
• Last updated: 2026-02-02

Locations

1 site across 1 country: Poland