Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa

Anorexia Nervosa Clinical Trial

— EVASTRAM  

Official title:

Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa : a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03813355
• Other study ID #: 1708195
• Secondary ID: 2018-A02866-49
• Status: Terminated
• Phase: N/A
• Start date: October 21, 2020
• Est. completion date: July 13, 2022

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Approximately 20% of anorexia nervosa cases do not respond to conventional management strategies: cognitive behavioral therapy, weight gain contract, drug treatments, etc ... - whether they are applied outpatients or during very long hospitalizations. These situations of chronic evolution are characterized by a high rate of mortality. Brain stimulation could be an alternative therapy for these patients. tDCS (transcranial direct current stimulation) is a non-invasive stimulation technique that has demonstrated beneficial effects in other psychiatric conditions such as major depression or schizophrenia. The objectives of the study will be to evaluate the efficacy of tDCS in anorexia nervosa resistant to conventional treatments on weight gain, eating behavior, psychological and nutritional behavioral scales, cognition, connectivity and brain activity.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: July 13, 2022
• Est. primary completion date: May 4, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 anorexia nervosa criteria
• Body Mass Index (BMI) < 17kg/m2
• Conventional treatment failure over the last 12 months
• Refusal or no indication of artificial nutrition

Exclusion Criteria:

• Artificial nutrition
• Other chronic diseases
• drug use (except tobacco)
• pregnancy
• Edinburgh score < 14

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Device:
• transcranial Direct Current Stimulation (tDCS)
transcranial Direct Current Stimulation (tDCS) during 20 sessions

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	CHU Grenoble	Grenoble
France	Hospices Civils de Lyon	Lyon
France	CHU Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index (BMI)	Change in body mass index after stimulation sessions. Weight and Height will be combined to report BMI in kg/m^2	weeks 8
Secondary	Eating Disorder Inventory (EDI)	Change in Eating Disorder Inventory scale after stimulation sessions; EDI measures : Drive for thinness (score between 0-4); Bulimia (score between 0-5); Body dissatisfaction (score between 3-10); ineffectiveness (score between 0-6); Perfectionism (score between 0-5); Interpersonal Distrust (score between 0-6); Interoceptive awareness (score between 0-4); Maturity Fears (score between 0-6)	weeks 8
Secondary	Dutch Eating Behavior Questionnaire (DEBQ)	Change in Dutch Eating Behavior Questionnaire (DEBQ) after stimulation sessions; DEBQ measures : Restrained eating (score between 10-30); Emotional eating (score between 17-35); external eating (score between 20-40)	weeks 8
Secondary	Beck Depression Inventory (BDI)	Change in Beck Depression Inventory after stimulation sessions.; BDI measures : No depression : score between 0-9; midl depression or anxiety : score between 10-19; moderate depression or anxiety : score between 20-25; moderate to severe depression or anxiety : score between 26-29; severe depression or anxiety : score between 30-40; very severe depression or anxiety : score between 41-84	weeks 8
Secondary	State-Trait Anxiety Inventory (STAI)	Change in State-Trait Anxiety Inventory (STAI) after stimulation sessions; STAI measures : no anxiety : score between 0-19; very low anxiety : score between 36-45; low anxiety : score between 46-55; moderate anxiety : score between 56-65; high anxiety : score between 56-65; very high anxiety : score greater than 65	weeks 8