Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa

NCT ID: NCT03813355

Last Updated: 2023-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-21

Study Completion Date

2022-07-13

Brief Summary

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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

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Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active stimulation

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

Group Type EXPERIMENTAL

transcranial Direct Current Stimulation (tDCS)

Intervention Type DEVICE

transcranial Direct Current Stimulation (tDCS) during 20 sessions

Sham stimulation

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

Group Type SHAM_COMPARATOR

transcranial Direct Current Stimulation (tDCS)

Intervention Type DEVICE

transcranial Direct Current Stimulation (tDCS) during 20 sessions

Interventions

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transcranial Direct Current Stimulation (tDCS)

transcranial Direct Current Stimulation (tDCS) during 20 sessions

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine Massoubre, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

CHU Grenoble

Grenoble, , France

Site Status

Hospices Civils de Lyon

Lyon, , France

Site Status

CHU Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2018-A02866-49

Identifier Type: OTHER

Identifier Source: secondary_id

1708195

Identifier Type: -

Identifier Source: org_study_id

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