NCT04782570

Psychotherapy of Anxiety Disorders With Noninvasive Brain Stimulation - Using Virtual Reality

Nicht-invasive Hirnstimulation in Der Psychotherapie Von Angsterkrankungen

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Wuerzburg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to transfer the rTMS stimulation protocol by Raij et al. (2018) into a therapeutic setting to improve exposure therapy in acrophobic patients. The quasi-randomized, placebo-controlled and double-blinded study will include 88 patients with height phobia (according to DSM 5). All participants will perform two exposure sessions in virtual reality (VR). Before exposure therapy, one group will receive verum rTMS of the left frontal cortex, which is indirectly functionally linked to the ventromedial prefrontal cortex (Raij et al., 2018). The control group will receive sham stimulation. A structural MRI and a TMS navigation system will be used for precise localization of the left FC. Anxiety symptoms will be measured using subjective ratings (e.g. Acrophobia Questionnaire) and the behavioural approach task (BAT) in VR and in real life before and after the treatment, and at 6 months follow-up. Furthermore, blood samples will be collected before rTMS and after exposure treatment to assess epigenetic and gene expression based changes.

Detailed description

The following hypotheses are derived: 1. Patients with acrophobia, who receive an active rTMS of the left FC before VRET, show a significantly stronger reduction of phobic symptoms immediately after exposure therapy, compared to the sham stimulation group. 2. Patients with acrophobia, who receive an active rTMS of the left FC before VRET, show a significantly greater increase in approach behavior and significantly less distress during the BAT immediately after exposure therapy, compared to the sham stimulation group. 3. The postulated differences in hypotheses 1 and 2 are still detectable at follow-up after 6 months.

Conditions

• Phobia

Interventions

Type	Name	Description
DEVICE	Verum TMS	Intensity of 100% of the resting motor threshold with iTBS. 600 stimuli applied in bursts of three pulses at 50 Hz given every 200 ms. iTBS will be applied 20 times for 2 s every 10 s.
DEVICE	Sham TMS	Sham stimulation with same protocol, but without magnetic stimulation

Timeline

• Start date: 2021-05-12
• Primary completion: 2022-09-27
• Completion: 2023-04-28
• First posted: 2021-03-04
• Last updated: 2023-08-02

Locations

1 site across 1 country: Germany