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NCT Number: NCT02734108

Transcranial Direct Current Stimulation (tDCS) and Anorexia Nervosa

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 .

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Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Lapeyronie

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

Anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    Evaluate the safety of this program: side effects, early termination of the patient, acceptability

  2. 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

    Evaluate the evolution of mood as an associated symptoms of anorexia nervosa

  3. 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

    Evaluate the evolution of mood as an associated symptoms of anorexia nervosa

  4. 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

    Evaluate the evolution of mood as an associated symptoms of anorexia nervosa

  5. 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

    Evaluate the evolution of physical activity as an associated symptoms of anorexia nervosa

  6. 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

    Evaluate the evolution of physical activity as an associated symptoms of anorexia nervosa

  7. 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

    Evaluate the evolution of obsessiveness as an associated symptoms of anorexia nervosa sensitivity

  8. 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

    Evaluate the evolution of reward sensitivity as an associated symptoms of anorexia nervosa sensitivity

  9. 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

    Evaluate the evolution of neuropsychological performance as an associated symptoms of anorexia nervosa sensitivity

  10. 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

    Evaluate the evolution of neuropsychological performance as an associated symptoms of anorexia nervosa sensitivity

  11. Evolution of the neuropsychological performance measured with the Brixton test

    Time frame: At the baseline and 1 month after the last session of tDCS

    Evaluate the evolution of neuropsychological performance as an associated symptoms of anorexia nervosa sensitivity

  12. 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

    Evaluate the evolution of neuropsychological performance as an associated symptoms of anorexia nervosa sensitivity

  13. Evolution of the neuropsychological performance measured with the D2 test

    Time frame: At the baseline and 1 month after the last session of tDCS

    Evaluate the evolution of neuropsychological performance as an associated symptoms of anorexia nervosa sensitivity

  14. Evolution of the patient's level of function measured with the Work and Social Adjustment Scale (WSAS)

    Time frame: 6 months

    Evaluate the evolution of the patient's level of function as an associated symptoms of anorexia nervosa sensitivity

  15. Evolution of the patient's level of function measured with the Global Assessment of Functioning (GAF)

    Time frame: 6 months

    Evaluate the evolution of the patient's level of function as an associated symptoms of anorexia nervosa sensitivity

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study 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

Acronym: STAR

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2016
Registry last updated
Dec 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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