Anorexia NervosaEVASTRAMNCT03813355
Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa
A study testing transcranial Direct Current Stimulation (tDCS) in people with Anorexia Nervosa, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 4 sitesFrance
- Study dates
- 21 Oct 2020to 13 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Artificial nutrition
- Other chronic diseases
- drug use (except tobacco)
- pregnancy
- Edinburgh score < 14
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU Clermont-Ferrand
Clermont-Ferrand
CHU Grenoble
Grenoble
Hospices Civils de Lyon
Lyon
CHU Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa : a Randomized Controlled Clinical Trial
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.
- Conditions
- Anorexia Nervosa
- Being tested
- transcranial Direct Current Stimulation (tDCS)
- Keywords
- brain stimulation, Body Mass Index
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial Direct Current Stimulation (tDCS)Device
transcranial Direct Current Stimulation (tDCS) during 20 sessions
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Experimental | Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with active stimulations Receives: Device: transcranial Direct Current Stimulation (tDCS) |
| Sham stimulation | Sham comparator | Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with inactive stimulations Receives: Device: transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: weeks 8
Secondary outcomes (4)
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)
Measured: weeks 8
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)
Measured: weeks 8
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
Measured: weeks 8
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
Measured: weeks 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start21 Oct 2020
- Primary completion4 May 2022
- Study completion13 Jul 2022
Why it stopped: lack of inclusion to meet the evaluation criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Massoubre, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813355
- Sponsor's protocol ID
- 1708195
- Other IDs
- 2018-A02866-49
- Acronym
- EVASTRAM
- Status last verified
- Feb 2023
- First submitted
- 20 Dec 2018
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa : a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03813355
- Acronym / sponsor ID
- EVASTRAM / 1708195
- Conditions
- Anorexia Nervosa
- Keywords
- brain stimulation, Body Mass Index
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of inclusion to meet the evaluation criteria
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Experimental | Device: transcranial Direct Current Stimulation (tDCS)Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with active stimulations |
| Sham stimulation | Sham comparator | Device: transcranial Direct Current Stimulation (tDCS)Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with inactive stimulations |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Artificial nutrition
- Other chronic diseases
- drug use (except tobacco)
- pregnancy
- Edinburgh score < 14
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial Direct Current Stimulation (tDCS)transcranial Direct Current Stimulation (tDCS) during 20 sessions | Device | Active stimulation, Sham stimulation |
Primary outcome
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
4 secondary outcomes
Eating Disorder Inventory (EDI)
Time frame: weeks 8
Dutch Eating Behavior Questionnaire (DEBQ)
Time frame: weeks 8
Beck Depression Inventory (BDI)
Time frame: weeks 8
State-Trait Anxiety Inventory (STAI)
Time frame: weeks 8
Results and safety
The study was stopped early (reason given: lack of inclusion to meet the evaluation criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Massoubre, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial Direct Current Stimulation (tDCS) in people with Anorexia Nervosa, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of inclusion to meet the evaluation criteria). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) (time frame: weeks 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.