Transcranial direct current stimulation (tDCS) in anorexia nervosa and bulimia nervosa

• Register: ISRCTN
• Last refreshed on: 19 October 2020
• Main ID: ISRCTN70396934
• Date of registration: 29/04/2014
• Prospective Registration: No
• Primary sponsor: King's College London (UK)
• Public title: Transcranial direct current stimulation (tDCS) in anorexia nervosa and bulimia nervosa
• Scientific title: An experimental sham-controlled crossover study of prefrontal cortex transcranial direct current stimulation (tDCS) in patients with anorexia nervosa and bulimia nervosa
• Date of first enrolment: 01/04/2014
• Target sample size: 72
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN70396934
• Study type: Interventional
• Study design: Single-centre randomised double-blind placebo-controlled crossover study (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Maria Kekic

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female
2. Aged over 18
3. Current DSM-V diagnosis of either:
3.1. Anorexia nervosa-restricting type
3.2. Anorexia nervosa-binge/purge type
3.3. Eating disorder not otherwise specified-anorexia type
3.4. Bulimia nervosa
3.5. Eating disorder not otherwise specified-bulimia type

Exclusion criteria:
1. Having a history of head or eye injury
2. Having a history of a neurological disease including previous seizures of any kind
3. Having a history of frequent or severe headaches
4. Having metallic implants in the head
5. Being on a dose of any psychotropic medication that has not been stable for at least 14 days prior to participation in the study
6. Taking antipsychotic medication
7. Taking anticonvulsive medication
8. Being pregnant
9. Smoking more than 15 cigarettes per day
10. Having a current major psychiatric disorder other than the eating disorder (e.g. major depressive disorder, substance use disorder, schizophrenia, or bipolar disorder) needing treatment in its own right
11. Having severe abnormalities in a blood test during the 30 days prior to participation


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Anorexia nervosa and bulimia nervosa
Mental and Behavioural Disorders
Anorexia nervosa, Bulimia nervosa

Intervention(s)

This study has three interventions:
1. Anode right/cathode left tDCS (active)
2. Anode left/cathode right tDCS (active)
3. Placebo tDCS

All participants will receive all three interventions (the order of stimulation will be randomised and counterbalanced across participants). A minimum 48-hour interval will be used between sessions to avoid any carryover effects due to stimulation. Each session will be 20 minutes long. Active tDCS will be delivered using a neuroConn® DC-STIMULATOR device at a constant current of 2 mA (with a 10-second fade in/out) using two 4 cm2 surface sponge electrodes soaked in a sterile saline solution (0.9% sodium chloride). The anode and cathode will be placed over the right (F4) and left (F3) dorsolateral prefrontal cortex (DLPFC), respectively, for intervention 1, and vice versa for intervention 2. The sites of interest will be located using the International EEG 10-20 system.

For placebo tDCS, the electrodes will be placed at the same sites as in active tDCS but the stimulation will automatically turn off after 30 seconds. Participants will therefore experience the initial itching sensation but will receive no current for the rest of the 20-minute session.

Primary Outcome(s)

The visual analogue scale (VAS) scores (0-10) obtained post-tDCS relating to hunger, urge to eat, urge to binge, urge to purge, urge to exercise, urge to restrict, feeling fat, and feeling full.

Secondary Outcome(s)

1. Post-tDCS VAS scores (0-10) relating to food ratings, stress, anxiety, tension, and mood.
2. Post-tDCS Mizes Eating Disorder Cognitions Questionnaire-Revised (MEDCQ-R) scores
3. Post-tDCS Profile of Mood States (POMS) scores
4. Post-tDCS delay discounting scores
5. Eating disorder symptoms (measured using VAS) at 24-hour follow-up
6. Blinding success
7. Tolerability of the intervention

Secondary ID(s)

N/A

Source(s) of Monetary Support

Institute of Psychiatry, King?s College London (UK)

Ethics review

Status:
Approval date:
Contact:

City Road and Hampstead National Research Ethics Service (NRES) committee;10/02/2014; ref: 14/LO/0025

Results

• Results available: Yes
• Date Completed: 30/09/2016