Transcranial Direct Current Stimulation (tDCS) in the Treatment of Anorexia Nervosa (SANO)

Silvie Ceresnakova

Status: Completed

Conditions: Anorexia Nervosa

Treatments: Device: Sham tDCS; Device: Anodal tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03273205

1955/16 S-IV

Details and patient eligibility

About

Anorexia Nervosa (AN) is a serious and often chronical eating disorder characterized by an extreme effort for weight loss and intense fear of becoming fat despite the obvious thinness. The treatment is very difficult and not always effective. That´s the reason why we are looking for new ways of the therapeutic approach.

Transcranial direct current stimulation (tDCS) is a neuromodulation technique, which modulates the neuronal excitability. According to previous research it has a potential to help people with Anorexia Nervosa.

The device for the tDCS has two electrodes, an anode (the excitatory one) and a cathode (the inhibitory one). We put them on the skull into the different positions, in dependence on the fact, if we want to excite or on to inhibit the parts of the brain under the electrodes.

There are several hypothesis how could the tDCS help in patients with AN. One of them speaks about the hyperactivity of the right hemisphere in Anorexia Nervosa. Therefore could the anodal (excitatory) tDCS over the left hemisphere and the cathodal (inhibitory one) help in resetting the inter-hemispheric balance.

Full description

Stimulation of 2 milliampere is applied for 30 minutes in every real session. Together there are 10 sessions, the application is every workday within 2 weeks.

All measurements and questionnaires are made 4 times:

1. Before the stimulation
2. On the day of the last stimulation
3. 14 days after the last stimulation
4. 28 days after the last stimulation

Enrollment: 43 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with the diagnosis of anorexia nervosa

Exclusion criteria

• patients: with the diagnosis of epilepsy, after a serious injury of head, with chronic headache, with some metal or electronic implants in their heads and patients who are pregnant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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43 participants in 2 patient groups

Anodal tDCS

Experimental group

Description:

The first group of patients has the real stimulation and the electrodes are placed in this position: Anode: Left DLPFC \[F3) Cathode: Right Supraorbital (FP2)

Treatment:

Device: Anodal tDCS

Sham tDCS

Sham Comparator group

Description:

The second group has the sham stimulation, but the electrodes are placed in the same position as in the first group: Anode: Left DLPFC \[F3) Cathode: Right Supraorbital (FP2)

Treatment:

Device: Sham tDCS