Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT05814458
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2023-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficiency of Transcranial Direct Current Stimulation in the Treatment of Anorexia Nervosa
Sponsor:
Medical University of Lublin
Organization:
Study Overview
Official Title:
The Efficiency of Transcranial Direct Current Stimulation in the Treatment of Anorexia Nervosa - a Randomised, Double-blind Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: