Anorexia NervosaSTARNCT02734108
Transcranial Direct Current Stimulation (tDCS) and Anorexia Nervosa
A study testing Transcranial direct current stimulation in people with Anorexia Nervosa, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Anorexia nervosa is an eating disorder characterized by intense fear of becoming fat despite the obvious thinness and extreme behaviors for weight loss. The result is a massive weight loss and / or pathological thinness. The care of anorexia is difficult and few treatments have proved to be effective in adults. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2016to 2 May 2018
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Present a current anorexia nervosa (according to Diagnostic and Statistical Manual of Mental Disorders (DSM V)) ,severe, for at least 3 years
- Attest to the failure of at least one outpatient treatment conducted by a specialized team (Level 2/3) for the management of patients with eating disorders according to the criteria of French Association for the Development of Specialized Approaches of eating disorders and General Direction of the care
- Have an effective mean of contraception throughout the study
- Being able to understand the nature, purpose and methodology of the study
- Being affiliated to a social security scheme or being the beneficiary of such a scheme.
- Having signed the informed consent
Who cannot join
- Refusal to participate
- Present a body mass index lower than 13.5
- Present a history of seizures or epilepsy
- Presenting a head injury and / or brain pathology
- Presenting an unstabilized serious physical illness
- Present pregnancy (attested by a blood test Beta-HCG) or breastfeeding
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- Present physical disease that may affect cognitive abilities and brain structures (eg HIV infection, multiple sclerosis, lupus, Parkinson's disease, epilepsy, dementia ...)
- Deprived of liberty subject (judicial or administrative decision)
- People protected by law
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring the Effect of a Program of 20 Sessions of Transcranial Direct Current Stimulation With 2 Milli-ampere Targeting the Dorsolateral Prefrontal Cortex on the Symptoms of Anorexia Nervosa: An Open Label Uncontrolled Pilots Study
Anorexia nervosa is an eating disorder characterized by intense fear of becoming fat despite the obvious thinness and extreme behaviors for weight loss. The result is a massive weight loss and / or pathological thinness. The care of anorexia is difficult and few treatments have proved to be effective in adults.
Transcranial direct current stimulation (tDCS) is a neuromodulation technique that uses an electrical current of low intensity. It allows to modulate the corticospinal excitability: two electrodes, an anode (excitatory) and a cathode (inhibitory), are positioned on the skull according to the region which is desired to influence the operation.
Read more
Although tDCS was shown to no noticeable side effects, it is first necessary to assess the feasibility and safety of this technique in these physically frail patients. A recent pilot study suggests the acceptability, safety and efficacy of tDCS program in patients with anorexia nervosa.
Given these preliminary data and the extreme seriousness and vulnerability of patients with resistant anorexia, the investigators want to assess the risk / benefit ratio for the use of this technique in patients suffering from resistant anorexia nervosa. The current data are too preliminary to consider a randomized controlled trial, the investigators hope, initially, replicate the data from this pilot study in a second sample with a more rigorous and comprehensive assessment methodology .
Read the detailed description
During stimulation, the anode will be placed over the left dorsolateral prefrontal cortex and the cathode on the right dorsolateral prefrontal cortex. Stimulation of 2 milli-Ampere is applied for 25 minutes each session.
20 sessions will be conducted twice a day respecting a period of four hours between sessions.
The tDCS sessions will start maximum 15 days after the inclusion visit.
Two intermediate control visits will be conducted. One after the first week of tDCS, the other immediately after the last session of tDCS.
The main assessment visit will be carried out one month (+/- 5 days) after the last session of tDCS. Finally a reminder visit will be performed 6 months (+/- 3 weeks) after the last session of tDCS to assess the stability over time of the potential effects observed.
- Conditions
- Anorexia Nervosa
- Being tested
- Transcranial direct current stimulation
- Keywords
- Sever anorexia nervosa
- 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 stimulationDevice
Anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex
| Study group | Role | What they receive |
|---|---|---|
| Transcranial direct current stimulation | Experimental | 10 patients will be stimulated twice a day for two weeks or 20 sessions. 2 milli ampere stimulation will be applied for 25 min respecting a period of four hours between sessions. Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the Eating Disorders Examination Questionnaire (EDEq) score
Comparison between the total score of the Eating Disorders Examination Questionnaire (EDEq) 28 days before tDCS program and 28 days after the end of a program of 20 sessions of tDCS with 2 milliampere targeting dorsolateral prefrontal cortex
Measured: At the baseline and 1 month after the last session of tDCS
Secondary outcomes (15)
Number of participants with treatment-related adverse events assessed by tDCS adverse effect questionnaire
Evaluate the safety of this program: side effects, early termination of the patient, acceptability
Measured: At the end of the first and second week of stimulation
Evolution of depressive symptoms assessed by patients with Beck Depression Inventory (BDI) questionnaire
Evaluate the evolution of mood as an associated symptoms of anorexia nervosa
Measured: At the baseline, the end of the first and second week of stimulation, 1 month and 6 months after the last session of tDCS
Evolution of depressive symptoms assessed by the psychiatrist by Montgomery Asberg Depression Rating Scale (MADRS)
Evaluate the evolution of mood as an associated symptoms of anorexia nervosa
Measured: At the baseline, 1 month and 6 months after the last session of tDCS
Evolution of mania symptoms assessed by the physician with Young Mania Rating Scale (YMRS)
Evaluate the evolution of mood as an associated symptoms of anorexia nervosa
Measured: At the baseline, the end of the first and second week of stimulation, 1 month and 6 months after the last session of tDCS
Evolution of the Exercise Dependence Scale (EDS-R) score
Evaluate the evolution of physical activity as an associated symptoms of anorexia nervosa
Measured: At the baseline, 1 month and 6 months after the last session of tDCS
Evolution of the Global Physical Activity Questionnaire (GPAQ) score
Evaluate the evolution of physical activity as an associated symptoms of anorexia nervosa
Measured: At the baseline, 1 month and 6 months after the last session of tDCS
Evolution of the Maudsley Obsessive Compulsive Inventory (MOCI) score
Evaluate the evolution of obsessiveness as an associated symptoms of anorexia nervosa sensitivity
Measured: At the baseline, 1 month and 6 months after the last session of tDCS
Evolution of the sensitivity to punishment and sensitivity reward questionnaire
Evaluate the evolution of reward sensitivity as an associated symptoms of anorexia nervosa sensitivity
Measured: At the baseline, 1 month and 6 months after the last session of tDCS
Evolution of the neuropsychological performance measured with the National Adult Reading Test (NART)
Evaluate the evolution of neuropsychological performance as an associated symptoms of anorexia nervosa sensitivity
Measured: At the baseline and 1 month after the last session of tDCS
Evolution of the neuropsychological performance measured with the Iowa Gambling Task (IGT)
Evaluate the evolution of neuropsychological performance as an associated symptoms of anorexia nervosa sensitivity
Measured: At the baseline and 1 month after the last session of tDCS
Evolution of the neuropsychological performance measured with the Brixton test
Evaluate the evolution of neuropsychological performance as an associated symptoms of anorexia nervosa sensitivity
Measured: At the baseline and 1 month after the last session of tDCS
Evolution of the neuropsychological performance measured with the Rey-Osterrieth Complex Figure
Evaluate the evolution of neuropsychological performance as an associated symptoms of anorexia nervosa sensitivity
Measured: At the baseline and 1 month after the last session of tDCS
Evolution of the neuropsychological performance measured with the D2 test
Evaluate the evolution of neuropsychological performance as an associated symptoms of anorexia nervosa sensitivity
Measured: At the baseline and 1 month after the last session of tDCS
Evolution of the patient's level of function measured with the Work and Social Adjustment Scale (WSAS)
Evaluate the evolution of the patient's level of function as an associated symptoms of anorexia nervosa sensitivity
Measured: 6 months
Evolution of the patient's level of function measured with the Global Assessment of Functioning (GAF)
Evaluate the evolution of the patient's level of function as an associated symptoms of anorexia nervosa sensitivity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study start6 Jan 2016
- Primary completion2 May 2018
- Study completion2 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien GUILLAUME, MD PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734108
- Sponsor's protocol ID
- UF 9587
- Other IDs
- 2015-A00872-47
- Acronym
- STAR
- Status last verified
- Dec 2021
- First submitted
- 8 Mar 2016
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Strumila R, Thiebaut S, Jaussent I, Seneque M, Attal J, Courtet P, Guillaume S. Safety and efficacy of transcranial direct current stimulation (tDCS) in the treatment of Anorexia Nervosa. The open-label STAR study. Brain Stimul. 2019 Sep-Oct;12(5):1325-1327. doi: 10.1016/j.brs.2019.06.017. Epub 2019 Jun 19. No abstract available.
PubMed 31239105
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Effect of a Program of 20 Sessions of Transcranial Direct Current Stimulation With 2 Milli-ampere Targeting the Dorsolateral Prefrontal Cortex on the Symptoms of Anorexia Nervosa: An Open Label Uncontrolled Pilots Study
- ClinicalTrials.gov ID
- NCT02734108
- Acronym / sponsor ID
- STAR / UF 9587
- Conditions
- Anorexia Nervosa
- Keywords
- Sever anorexia nervosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 6 Jan 2016 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 12 Apr 2016 (estimated)
- 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.
Anorexia nervosa is an eating disorder characterized by intense fear of becoming fat despite the obvious thinness and extreme behaviors for weight loss. The result is a massive weight loss and / or pathological thinness. The care of anorexia is difficult and few treatments have proved to be effective in adults.
Transcranial direct current stimulation (tDCS) is a neuromodulation technique that uses an electrical current of low intensity. It allows to modulate the corticospinal excitability: two electrodes, an anode (excitatory) and a cathode (inhibitory), are positioned on the skull according to the region which is desired to influence the operation.
Although tDCS was shown to no noticeable side effects, it is first necessary to assess the feasibility and safety of this technique in these physically frail patients. A recent pilot study suggests the acceptability, safety and efficacy of tDCS program in patients with anorexia nervosa.
Given these preliminary data and the extreme seriousness and vulnerability of patients with resistant anorexia, the investigators want to assess the risk / benefit ratio for the use of this technique in patients suffering from resistant anorexia nervosa. The current data are too preliminary to consider a randomized controlled trial, the investigators hope, initially, replicate the data from this pilot study in a second sample with a more rigorous and comprehensive assessment methodology .
Detailed description
During stimulation, the anode will be placed over the left dorsolateral prefrontal cortex and the cathode on the right dorsolateral prefrontal cortex. Stimulation of 2 milli-Ampere is applied for 25 minutes each session.
20 sessions will be conducted twice a day respecting a period of four hours between sessions.
The tDCS sessions will start maximum 15 days after the inclusion visit.
Two intermediate control visits will be conducted. One after the first week of tDCS, the other immediately after the last session of tDCS.
The main assessment visit will be carried out one month (+/- 5 days) after the last session of tDCS. Finally a reminder visit will be performed 6 months (+/- 3 weeks) after the last session of tDCS to assess the stability over time of the potential effects observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial direct current stimulation | Experimental | Device: Transcranial direct current stimulation10 patients will be stimulated twice a day for two weeks or 20 sessions. 2 milli ampere stimulation will be applied for 25 min respecting a period of four hours between sessions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Present a current anorexia nervosa (according to Diagnostic and Statistical Manual of Mental Disorders (DSM V)) ,severe, for at least 3 years
- Attest to the failure of at least one outpatient treatment conducted by a specialized team (Level 2/3) for the management of patients with eating disorders according to the criteria of French Association for the Development of Specialized Approaches of eating disorders and General Direction of the care
- Have an effective mean of contraception throughout the study
- Being able to understand the nature, purpose and methodology of the study
- Being affiliated to a social security scheme or being the beneficiary of such a scheme.
Key exclusion criteria (9 listed)
- Refusal to participate
- Present a body mass index lower than 13.5
- Present a history of seizures or epilepsy
- Presenting a head injury and / or brain pathology
- Presenting an unstabilized serious physical illness
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 stimulationAnodal transcranial direct current stimulation over the dorsolateral prefrontal cortex | Device | Transcranial direct current stimulation |
Primary outcome
Evolution of the Eating Disorders Examination Questionnaire (EDEq) score
Time frame: At the baseline and 1 month after the last session of tDCS
Comparison between the total score of the Eating Disorders Examination Questionnaire (EDEq) 28 days before tDCS program and 28 days after the end of a program of 20 sessions of tDCS with 2 milliampere targeting dorsolateral prefrontal cortex
15 secondary outcomes
Number of participants with treatment-related adverse events assessed by tDCS adverse effect questionnaire
Time frame: At the end of the first and second week of stimulation
Evolution of depressive symptoms assessed by patients with Beck Depression Inventory (BDI) questionnaire
Time frame: At the baseline, the end of the first and second week of stimulation, 1 month and 6 months after the last session of tDCS
Evolution of depressive symptoms assessed by the psychiatrist by Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: At the baseline, 1 month and 6 months after the last session of tDCS
Evolution of mania symptoms assessed by the physician with Young Mania Rating Scale (YMRS)
Time frame: At the baseline, the end of the first and second week of stimulation, 1 month and 6 months after the last session of tDCS
Evolution of the Exercise Dependence Scale (EDS-R) score
Time frame: At the baseline, 1 month and 6 months after the last session of tDCS
Evolution of the Global Physical Activity Questionnaire (GPAQ) score
Time frame: At the baseline, 1 month and 6 months after the last session of tDCS
Evolution of the Maudsley Obsessive Compulsive Inventory (MOCI) score
Time frame: At the baseline, 1 month and 6 months after the last session of tDCS
Evolution of the sensitivity to punishment and sensitivity reward questionnaire
Time frame: At the baseline, 1 month and 6 months after the last session of tDCS
Evolution of the neuropsychological performance measured with the National Adult Reading Test (NART)
Time frame: At the baseline and 1 month after the last session of tDCS
Evolution of the neuropsychological performance measured with the Iowa Gambling Task (IGT)
Time frame: At the baseline and 1 month after the last session of tDCS
Evolution of the neuropsychological performance measured with the Brixton test
Time frame: At the baseline and 1 month after the last session of tDCS
Evolution of the neuropsychological performance measured with the Rey-Osterrieth Complex Figure
Time frame: At the baseline and 1 month after the last session of tDCS
Evolution of the neuropsychological performance measured with the D2 test
Time frame: At the baseline and 1 month after the last session of tDCS
Evolution of the patient's level of function measured with the Work and Social Adjustment Scale (WSAS)
Time frame: 6 months
Evolution of the patient's level of function measured with the Global Assessment of Functioning (GAF)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Background: PubMed 31239105Strumila R, Thiebaut S, Jaussent I, Seneque M, Attal J, Courtet P, Guillaume S. Safety and efficacy of transcranial direct current stimulation (tDCS) in the treatment of Anorexia Nervosa. The open-label STAR study. Brain Stimul. 2019 Sep-Oct;12(5):1325-1327. doi: 10.1016/j.brs.2019.06.017. Epub 2019 Jun 19. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Sébastien GUILLAUME, MD PhD principal investigator
University Hospital, Montpellier
1 site 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 in people with Anorexia Nervosa, run by University Hospital, Montpellier at 1 site 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evolution of the Eating Disorders Examination Questionnaire (EDEq) score (time frame: At the baseline and 1 month after the last session of tDCS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02734108, which also lists 1 linked publication.
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 21 Dec 2021.