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Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa (EVASTRAM)

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ClinicalTrials.gov Identifier: NCT03813355
Recruitment Status : Not yet recruiting
First Posted : January 23, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Netherlands: Ministry of Health, Welfare and Sports
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief 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.


Condition or disease Intervention/treatment Phase
Anorexia Nervosa Device: transcranial Direct Current Stimulation (tDCS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa : a Randomized Controlled Clinical Trial
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: Active stimulation
Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with active stimulations
Device: transcranial Direct Current Stimulation (tDCS)
transcranial Direct Current Stimulation (tDCS) during 20 sessions

Sham Comparator: Sham stimulation
Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with inactive stimulations
Device: transcranial Direct Current Stimulation (tDCS)
transcranial Direct Current Stimulation (tDCS) during 20 sessions




Primary Outcome Measures :
  1. Body Mass Index (BMI) [ Time Frame: weeks 8 ]
    Change in body mass index after stimulation sessions. Weight and Height will be combined to report BMI in kg/m^2


Secondary Outcome Measures :
  1. Eating Disorder Inventory (EDI) [ Time Frame: weeks 8 ]

    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)

  2. Dutch Eating Behavior Questionnaire (DEBQ) [ Time Frame: weeks 8 ]

    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)

  3. Beck Depression Inventory (BDI) [ Time Frame: weeks 8 ]

    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

  4. State-Trait Anxiety Inventory (STAI) [ Time Frame: weeks 8 ]

    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 anorexia nervosa criteria
  • Body Mass Index (BMI) < 14kg/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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03813355


Contacts
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Contact: Catherine Massoubre, PhD 0477829390 catherine.massoubre@chu-st-etienne.fr
Contact: Bogdan Galusca, PhD bogdan.galusca@chu-st-etienne.fr

Locations
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France
CHU Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France
Contact: Pierre-Michel Llorca, PhD         
Principal Investigator: Pierre-Michel Llorca, PhD         
CHU Grenoble Not yet recruiting
Grenoble, France
Contact: Thierry Bougerol, PhD         
Principal Investigator: Thierry Bougerol, PhD         
Hospices Civils de Lyon Not yet recruiting
Lyon, France
Contact: Sylvain Iceta         
Principal Investigator: Sylvain Iceta, MD         
CHU Saint-Etienne Not yet recruiting
Saint-Etienne, France, 42055
Contact: Catherine Massoubre, PhD       catherine.massoubre@chu-st-etienne.fr   
Sub-Investigator: Bogdan Galusca         
Principal Investigator: Catherine Massoubre         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Netherlands: Ministry of Health, Welfare and Sports
Investigators
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Principal Investigator: Catherine Massoubre, PhD CHU Saint-Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03813355     History of Changes
Other Study ID Numbers: 1708195
2018-A02866-49 ( Other Identifier: ANSM )
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
brain stimulation
Body Mass Index
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders