NCT03813355

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

October 21, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2022

Completed
Last Updated

April 6, 2023

Status Verified

February 1, 2023

Enrollment Period

1.5 years

First QC Date

December 20, 2018

Last Update Submit

April 5, 2023

Conditions

Anorexia Nervosa

Keywords

brain stimulationBody Mass Index

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Eating Disorder Inventory (EDI)

    weeks 8

  • Dutch Eating Behavior Questionnaire (DEBQ)

    weeks 8

  • Beck Depression Inventory (BDI)

    weeks 8

  • State-Trait Anxiety Inventory (STAI)

    weeks 8

Study Arms (2)

Active stimulation

EXPERIMENTAL

Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with active stimulations

Device: transcranial Direct Current Stimulation (tDCS)

Sham stimulation

SHAM COMPARATOR

Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with inactive stimulations

Device: transcranial Direct Current Stimulation (tDCS)

Interventions

transcranial Direct Current Stimulation (tDCS)DEVICE

transcranial Direct Current Stimulation (tDCS) during 20 sessions

Active stimulationSham stimulation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

CHU Grenoble

Grenoble, France

Location

Hospices Civils de Lyon

Lyon, France

Location

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Catherine Massoubre, PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2018

First Posted

January 23, 2019

Study Start

October 21, 2020

Primary Completion

May 4, 2022

Study Completion

July 13, 2022

Last Updated

April 6, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)