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

Anorexia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05814458
• Other study ID #: KE-0254/24/01/2022
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Medical University of Lublin
• Contact: Zuzanna Rzad, MS
• Phone: (+48) 517259754
• Email: rzadzuzanna[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	Ist Department of Psychiatry, Psychotherapy and Early Intervention	Lublin

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lublin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
Primary	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)
Primary	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)
Primary	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)
Primary	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 three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
Primary	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)
Primary	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 twice: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Primary	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 two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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 test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
Primary	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)
Primary	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)
Secondary	Change in electrolyte levels	To evaluate electrolyte levels (mmol/l) in blood serum following tests will be performed: sodium, phosphorus, magnesium, calcium	The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Secondary	Change in morphotic elements 1	To evaluate morphotic elements complete morphology with smear will be performed: RBC - Red Blood Cell (M/µl)	The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Secondary	Change in morphotic elements 2	To evaluate morphotic elements complete morphology with smear will be performed: Hemoglobin (mmol/l) Mean Corpuscular Hemoglobin Concentration (mmol/l)	The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Secondary	Change in morphotic elements 3	To evaluate morphotic elements complete morphology with smear will be performed: Hematocrit	The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Secondary	Change in morphotic elements 4	To evaluate morphotic elements complete morphology with smear will be performed: Mean Corpuscular Volume (fl)	The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Secondary	Change in morphotic elements 5	To evaluate morphotic elements complete morphology with smear will be performed: Mean Corpuscular Hemoglobin (pg)	The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Secondary	Change in morphotic elements 6	To evaluate morphotic elements complete morphology with smear will be performed: Ferritin ( ng/ml)	The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Secondary	Change in morphotic elements 7	To evaluate morphotic elements complete morphology with smear will be performed: White Blood Cell (K/µl) Lymphocytes (K/µl)	The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Secondary	Change in morphotic elements 8	To evaluate morphotic elements complete morphology with smear will be performed: Monocytes (G/l)	The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Secondary	Metabolic changes 1	To evaluate metabolic changes in blood serum Thyroid parameters will be examined: FT3 (pmol/l), FT4 (pmol/l)	The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Secondary	Metabolic changes 2	To evaluate metabolic changes in blood serum the pituitary gland parameter will be examined: TSH (µIU/ml)	The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Secondary	Neurophysiologic changes 1	To evaluate neurophysiologic changes EEG (theta and alpha wave power) test will be performed	The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Secondary	Change in neurotrophin levels	To evaluate neurotrophin levels in blood serum tests will be performed: BDNF (pg/ml), Neurotrphin 3 and 4 (pg/ml), NGF (pg/ml)	The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Secondary	Change in food intake regulators:	To evaluate food intake regulators in blood serum tests will be performed: leptin (pg/ml), visfatin (pg/ml)	The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Secondary	Body composition changes 1	To evaluate body composition changes BIA body composition analysis will be performed: Body weight (kg)	The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
Secondary	Body composition changes 2	To evaluate body composition changes BIA body composition analysis will be performed: Intracellular and extracellular water (l/%)	The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
Secondary	Body composition changes 3	To evaluate body composition changes BIA body composition analysis will be performed: Lean body mass (kg/%)	The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
Secondary	Body composition changes 4	To evaluate body composition changes BIA body composition analysis will be performed: Fat mass (kg/%)	The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
Secondary	Changes in HPA axis biomarker	To evaluate HPA axis cortisol (nmol/l) in blood serum will be tested	The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)