Transcranial Direct Current Stimulation (tDCS) and Anorexia Nervosa (STAR)

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.

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 .

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Device: Transcranial direct current stimulation

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Hôpital Lapeyronie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcranial direct current stimulation; 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; Anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Sébastien GUILLAUME, MD PhD, University Hospital, Montpellier

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2016
• Primary Completion (Actual): May 2, 2018
• Study Completion (Actual): May 2, 2018

Study Registration Dates

• First Submitted: March 8, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (Estimate): April 12, 2016

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Sever anorexia nervosa
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: UF 9587; 2015-A00872-47 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided