Transcranial Direct Current Stimulation (tDCS) and Anorexia Nervosa

NCT02734108 | Completed DMC

• 2 other identifiers: UF 95872015-A00872-47
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 .

Conditions

Anorexia Nervosa

Keywords

Sever anorexia nervosa

Outcome Measures

Primary Outcomes (1)

• 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

  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

  At the end of the first and second week of stimulation

• Evolution of depressive symptoms assessed by patients with Beck Depression Inventory (BDI) questionnaire

  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)

  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)

  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

  At the baseline, 1 month and 6 months after the last session of tDCS

Study Arms (1)

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.

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulation DEVICE

Anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex

Transcranial direct current stimulation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Hopital Lapeyronie

Montpellier, 34295, France

Location

Related Publications (1)

• 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.

  PMID: 31239105 BACKGROUND

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Sébastien GUILLAUME, MD PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: April 12, 2016
• Study Start: January 6, 2016
• Primary Completion: May 2, 2018
• Study Completion: May 2, 2018
• Last Updated: December 21, 2021

Record last verified: 2021-12

Locations

FR (1)