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

Primary Purpose

Anorexia Nervosa

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
tDCS
Placebo
Sponsored by
Medical University of Lublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Anorexia Nervosa, Brain stimulation, Eating disorders, Left dorsolateral prefrontal cortex, Transcranial direct current stimulation

Eligibility Criteria

13 Years - 25 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ist Department of Psychiatry, Psychotherapy and Early InterventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

tDCS group

Placebo group

Arm Description

The tDCS group will receive the active brain stimulation.

The placebo group will receive the sham brain stimulation.

Outcomes

Primary Outcome Measures

Change in severity of eating disorder symptoms 1
The severity of symptoms will be assessed with Eating Attitudes Test (EAT-26)
Change in severity of eating disorder symptoms 2
The severity of symptoms will be assessed with Eating Disorder Examination Questionnaire (EDE-Q 6.0).
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.
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.
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.
Change in severity of depressive symptoms 1
Severity of depressive symptoms will be assessed with Beck's Depression Inventory (BDI)
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).
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,".
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.
Change in intensity of intrusive thoughts
To assess intensity of intrusive thoughts CY-BOCS scale will be used
Change in intensity of rumination
To assess intensity of rumination the Ruminance-Reflectivity Questionnaire will be used
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.
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.
Change in cognitive abilities 1
To assess cognitive abilities Matching Familiar Figures Test (MFF)
Change in cognitive abilities 2
To assess cognitive abilities Verbal Fluency Test will be used.

Secondary Outcome Measures

Change in electrolyte levels
To evaluate electrolyte levels (mmol/l) in blood serum following tests will be performed: sodium, phosphorus, magnesium, calcium
Change in morphotic elements 1
To evaluate morphotic elements complete morphology with smear will be performed: RBC - Red Blood Cell (M/µl)
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)
Change in morphotic elements 3
To evaluate morphotic elements complete morphology with smear will be performed: Hematocrit
Change in morphotic elements 4
To evaluate morphotic elements complete morphology with smear will be performed: Mean Corpuscular Volume (fl)
Change in morphotic elements 5
To evaluate morphotic elements complete morphology with smear will be performed: Mean Corpuscular Hemoglobin (pg)
Change in morphotic elements 6
To evaluate morphotic elements complete morphology with smear will be performed: Ferritin ( ng/ml)
Change in morphotic elements 7
To evaluate morphotic elements complete morphology with smear will be performed: White Blood Cell (K/µl) Lymphocytes (K/µl)
Change in morphotic elements 8
To evaluate morphotic elements complete morphology with smear will be performed: Monocytes (G/l)
Metabolic changes 1
To evaluate metabolic changes in blood serum Thyroid parameters will be examined: FT3 (pmol/l), FT4 (pmol/l)
Metabolic changes 2
To evaluate metabolic changes in blood serum the pituitary gland parameter will be examined: TSH (µIU/ml)
Neurophysiologic changes 1
To evaluate neurophysiologic changes EEG (theta and alpha wave power) test will be performed
Neurophysiologic changes 2
To evaluate neurophysiologic changes fNIRs test will be performed
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)
Change in food intake regulators:
To evaluate food intake regulators in blood serum tests will be performed: leptin (pg/ml), visfatin (pg/ml)
Body composition changes 1
To evaluate body composition changes BIA body composition analysis will be performed: Body weight (kg)
Body composition changes 2
To evaluate body composition changes BIA body composition analysis will be performed: Intracellular and extracellular water (l/%)
Body composition changes 3
To evaluate body composition changes BIA body composition analysis will be performed: Lean body mass (kg/%)
Body composition changes 4
To evaluate body composition changes BIA body composition analysis will be performed: Fat mass (kg/%)
Changes in HPA axis biomarker
To evaluate HPA axis cortisol (nmol/l) in blood serum will be tested

Full Information

First Posted
January 31, 2023
Last Updated
April 12, 2023
Sponsor
Medical University of Lublin
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1. Study Identification

Unique Protocol Identification Number
NCT05814458
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Lublin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Anorexia Nervosa, Brain stimulation, Eating disorders, Left dorsolateral prefrontal cortex, Transcranial direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tDCS group
Arm Type
Active Comparator
Arm Description
The tDCS group will receive the active brain stimulation.
Arm Title
Placebo group
Arm Type
Sham Comparator
Arm Description
The placebo group will receive the sham brain stimulation.
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in severity of eating disorder symptoms 1
Description
The severity of symptoms will be assessed with Eating Attitudes Test (EAT-26)
Time Frame
The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
Title
Change in severity of eating disorder symptoms 2
Description
The severity of symptoms will be assessed with Eating Disorder Examination Questionnaire (EDE-Q 6.0).
Time Frame
The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
Title
Change in eating habits and opinions about food and nutrition
Description
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.
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and two weeks after intervention (V3)
Title
Change in food intake variety
Description
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.
Time Frame
The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
Title
Change in assessment of stress levels
Description
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.
Time Frame
The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
Title
Change in severity of depressive symptoms 1
Description
Severity of depressive symptoms will be assessed with Beck's Depression Inventory (BDI)
Time Frame
The tests will be performed twice: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Change in severity of depressive symptoms 2
Description
Severity of depressive symptoms will be assessed with Questionnaire for the Diagnosis of Depression in Children and Adolescents (CDI2).
Time Frame
The tests will be performed twice: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Change in meta-cognition
Description
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,".
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Change in attention and perceptiveness
Description
To assess levels of attention Color connection test (CTT-1, CTT-2) and Test of attention and perceptiveness will be used.
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Change in intensity of intrusive thoughts
Description
To assess intensity of intrusive thoughts CY-BOCS scale will be used
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Change in intensity of rumination
Description
To assess intensity of rumination the Ruminance-Reflectivity Questionnaire will be used
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Change in visual memory
Description
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.
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Change in body image self-esteem
Description
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.
Time Frame
The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
Title
Change in cognitive abilities 1
Description
To assess cognitive abilities Matching Familiar Figures Test (MFF)
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Change in cognitive abilities 2
Description
To assess cognitive abilities Verbal Fluency Test will be used.
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Secondary Outcome Measure Information:
Title
Change in electrolyte levels
Description
To evaluate electrolyte levels (mmol/l) in blood serum following tests will be performed: sodium, phosphorus, magnesium, calcium
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Change in morphotic elements 1
Description
To evaluate morphotic elements complete morphology with smear will be performed: RBC - Red Blood Cell (M/µl)
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Change in morphotic elements 2
Description
To evaluate morphotic elements complete morphology with smear will be performed: Hemoglobin (mmol/l) Mean Corpuscular Hemoglobin Concentration (mmol/l)
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Change in morphotic elements 3
Description
To evaluate morphotic elements complete morphology with smear will be performed: Hematocrit
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Change in morphotic elements 4
Description
To evaluate morphotic elements complete morphology with smear will be performed: Mean Corpuscular Volume (fl)
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Change in morphotic elements 5
Description
To evaluate morphotic elements complete morphology with smear will be performed: Mean Corpuscular Hemoglobin (pg)
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Change in morphotic elements 6
Description
To evaluate morphotic elements complete morphology with smear will be performed: Ferritin ( ng/ml)
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Change in morphotic elements 7
Description
To evaluate morphotic elements complete morphology with smear will be performed: White Blood Cell (K/µl) Lymphocytes (K/µl)
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Change in morphotic elements 8
Description
To evaluate morphotic elements complete morphology with smear will be performed: Monocytes (G/l)
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Metabolic changes 1
Description
To evaluate metabolic changes in blood serum Thyroid parameters will be examined: FT3 (pmol/l), FT4 (pmol/l)
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Metabolic changes 2
Description
To evaluate metabolic changes in blood serum the pituitary gland parameter will be examined: TSH (µIU/ml)
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Neurophysiologic changes 1
Description
To evaluate neurophysiologic changes EEG (theta and alpha wave power) test will be performed
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Neurophysiologic changes 2
Description
To evaluate neurophysiologic changes fNIRs test will be performed
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Change in neurotrophin levels
Description
To evaluate neurotrophin levels in blood serum tests will be performed: BDNF (pg/ml), Neurotrphin 3 and 4 (pg/ml), NGF (pg/ml)
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Change in food intake regulators:
Description
To evaluate food intake regulators in blood serum tests will be performed: leptin (pg/ml), visfatin (pg/ml)
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Title
Body composition changes 1
Description
To evaluate body composition changes BIA body composition analysis will be performed: Body weight (kg)
Time Frame
The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
Title
Body composition changes 2
Description
To evaluate body composition changes BIA body composition analysis will be performed: Intracellular and extracellular water (l/%)
Time Frame
The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
Title
Body composition changes 3
Description
To evaluate body composition changes BIA body composition analysis will be performed: Lean body mass (kg/%)
Time Frame
The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
Title
Body composition changes 4
Description
To evaluate body composition changes BIA body composition analysis will be performed: Fat mass (kg/%)
Time Frame
The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
Title
Changes in HPA axis biomarker
Description
To evaluate HPA axis cortisol (nmol/l) in blood serum will be tested
Time Frame
The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zuzanna Rząd, MS
Phone
(+48) 517259754
Email
rzadzuzanna@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Paweł Szewczyk, MS
Phone
(+48) 501660344
Email
pawel.szewczyk33@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanna Karakuła-Juchnowicz, Prof.
Organizational Affiliation
1st Department of Psychiatry, Psychotherapy and Early Intervention, Medical University of Lublin
Official's Role
Study Director
Facility Information:
Facility Name
Ist Department of Psychiatry, Psychotherapy and Early Intervention
City
Lublin
ZIP/Postal Code
20-439
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zuzanna Rząd, MS
Phone
(+48) 517259754
Email
rzadzuzanna@gmail.com
First Name & Middle Initial & Last Name & Degree
Paweł Szewczyk, MS
Phone
(+48)501660344
Email
pawel.szewczyk33@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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