Clinical Trial: Transcranial Direct Current Stimulation (tDCS) and Anorexia Nervosa

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 An

Brief 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.

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 Summary:

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.


Sponsor: University Hospital, Montpellier

Current 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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


Original Secondary Outcome: Same as current

Information By: University Hospital, Montpellier

Dates:
Date Received: March 8, 2016
Date Started: January 2016
Date Completion: May 2017
Last Updated: April 11, 2016
Last Verified: December 2015