NCT04782570

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 12, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2023

Completed
Last Updated

August 2, 2023

Status Verified

August 1, 2023

Enrollment Period

1.4 years

First QC Date

February 23, 2021

Last Update Submit

August 1, 2023

Conditions

Phobia

Keywords

VRExposure therapyAcrophobiarTMSPFC

Outcome Measures

Primary Outcomes (1)

  • Subjective anxiety symptoms

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

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

Secondary Outcomes (3)

  • Subjective anxiety in behavioral approach tests (BAT)

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

  • Subjective anxiety symptoms (Follow-Up)

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

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

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

Study Arms (2)

Verum TMS

EXPERIMENTAL

ITBS (intermittent Theta Burst Stimulation) over left frontal cortex

Device: Verum TMS

Sham TMS

SHAM COMPARATOR

Sham TMS over left frontal cortex

Device: Sham TMS

Interventions

Verum TMSDEVICE

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.

Also known as: Cool-B70 A/P, MagPro X100, MagVenture®, Denmark
Verum TMS
Sham TMSDEVICE

Sham stimulation with same protocol, but without magnetic stimulation

Also known as: Cool-B70 A/P, MagPro X100,, MagVenture®, Denmark
Sham TMS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Martin J. Herrmann

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

Phobic DisordersAcrophobia

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Martin J. Herrmann, PhD

    University of Würzburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2021

First Posted

March 4, 2021

Study Start

May 12, 2021

Primary Completion

September 27, 2022

Study Completion

April 28, 2023

Last Updated

August 2, 2023

Record last verified: 2023-08

Locations

DE(1)