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

NCT ID: NCT04782570

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-12
• Study Completion Date: 2023-04-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Verum TMS

ITBS (intermittent Theta Burst Stimulation) over left frontal cortex

Group Type: EXPERIMENTAL

Verum TMS

Intervention Type: DEVICE

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.

Sham TMS

Sham TMS over left frontal cortex

Group Type: SHAM_COMPARATOR

Sham TMS

Intervention Type: DEVICE

Sham stimulation with same protocol, but without magnetic stimulation

Interventions

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.

Intervention Type: DEVICE

Sham TMS

Sham stimulation with same protocol, but without magnetic stimulation

Intervention Type: DEVICE

Other Intervention Names

Cool-B70 A/P, MagPro X100, MagVenture®, Denmark; Cool-B70 A/P, MagPro X100,, MagVenture®, Denmark

Eligibility Criteria

Inclusion Criteria

• Acrophobia (according to DSM-5)
• Right handed
• German native speaker
• Written informed consent

Exclusion Criteria

• Neurological and/or severe physical illnesses
• Comorbid Axis I disorder (other than phobias)
• Pretreated phobia of heights
• Use of tricyclic antidepressants, antipsychotics, or other substances that increase cerebral seizure susceptibility
• Craniocerebral injuries, head surgery
• Epileptic seizures, or family history of epilepsy
• Metal parts in the head area
• Cardiac pacemakers
• Infusion pumps
• Heart diseases
• Increased intracranial pressure
• Pregnancy
• Cochlear implants
• Tattoos (done before the year 2000)
• Piercings (if not completely removable)
• Permanent make-up
• Nicotine or pain patches
• other MRI contraindications

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wuerzburg

OTHER

Sponsor Role: collaborator

Wuerzburg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin J. Herrmann, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Würzburg

Locations

Martin J. Herrmann

Würzburg, , Germany

Countries

Germany

Other Identifiers

PAN_VR

Identifier Type: OTHER

Identifier Source: secondary_id

Wuerzburg45/20-am

Identifier Type: -

Identifier Source: org_study_id