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Completed

NCT Number: NCT04782570

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

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.

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Key information

Conditions

Phobia Acrophobia Anxiety Disorders Mental Disorders Phobic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Martin J. Herrmann

Würzburg, 97080, Germany

About this study

The following hypotheses are derived:

  • 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.
  • 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.
  • The postulated differences in hypotheses 1 and 2 are still detectable at follow-up after 6 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Verum TMS

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.

Other names: Cool-B70 A/P, MagPro X100, MagVenture®, Denmark

Sham TMS

Device

Sham stimulation with same protocol, but without magnetic stimulation

Other names: Cool-B70 A/P, MagPro X100,, MagVenture®, Denmark

Primary outcomes

  1. Subjective anxiety symptoms

    Time frame: change from T1 (baseline /study start) to T4 (immediately after treatment)

    Acrophobia Questionnaire (Cohen, 1977) with two subscales: 1) degree of anxiety (ACRO) and 2) degree of avoidance (AVOI) in height-related situations.

Secondary outcomes

  1. Subjective anxiety in behavioral approach tests (BAT)

    Time frame: change from T1 (baseline /study start) to T4 (immediately after treatment)

    anxiety measurement by a behavioral approach test (BAT) in virtual reality (glass elevator on the outside of an high-rise building, height up to 150m) and in real life (open stairwell height up to 11,6m).

  2. Subjective anxiety symptoms (Follow-Up)

    Time frame: change from T1 (baseline/ study start) to T28 (6 months follow-up)

    Acrophobia Questionnaire (Cohen, 1977) with two subscales: 1) degree of anxiety (ACRO) and 2) degree of avoidance (AVOI) in height-related situations.

  3. Subjective anxiety in behavioral approach tests (BAT) (Follow-Up)

    Time frame: change from T1 (baseline /study start) to T28 (6 months follow-up)

    anxiety measurement by a behavioral approach test (BAT) in virtual reality (glass elevator on the outside of an high-rise building, height up to 150m) and in real life (open stairwell height up to 11,6m).

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Collaborators

  • University of Wuerzburg

Registry information

Official study title

Nicht-invasive Hirnstimulation in Der Psychotherapie Von Angsterkrankungen

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 4, 2021
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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