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Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa (EVASTRAM)

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ClinicalTrials.gov Identifier: NCT03813355
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Tracking Information
First Submitted Date  ICMJE December 20, 2018
First Posted Date  ICMJE January 23, 2019
Last Update Posted Date July 27, 2021
Actual Study Start Date  ICMJE October 21, 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • 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)
  • 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)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa
Official Title  ICMJE Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa : a Randomized Controlled Clinical Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anorexia Nervosa
Intervention  ICMJE Device: transcranial Direct Current Stimulation (tDCS)
transcranial Direct Current Stimulation (tDCS) during 20 sessions
Study Arms  ICMJE
  • Experimental: Active stimulation
    Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with active stimulations
    Intervention: Device: transcranial Direct Current Stimulation (tDCS)
  • Sham Comparator: Sham stimulation
    Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with inactive stimulations
    Intervention: Device: transcranial Direct Current Stimulation (tDCS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 22, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Catherine Massoubre, PhD 0477829390 catherine.massoubre@chu-st-etienne.fr
Contact: Bogdan Galusca, PhD bogdan.galusca@chu-st-etienne.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03813355
Other Study ID Numbers  ICMJE 1708195
2018-A02866-49 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Saint Etienne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Catherine Massoubre, PhD CHU Saint-Etienne
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP