Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04782570
Other study ID # Wuerzburg45/20-am
Secondary ID PAN_VR
Status Completed
Phase N/A
First received
Last updated
Start date May 12, 2021
Est. completion date April 28, 2023

Study information

Verified date August 2023
Source Wuerzburg University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 87
Est. completion date April 28, 2023
Est. primary completion date September 27, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
Sham TMS
Sham stimulation with same protocol, but without magnetic stimulation

Locations

Country Name City State
Germany Martin J. Herrmann Würzburg

Sponsors (2)

Lead Sponsor Collaborator
Wuerzburg University Hospital University of Wuerzburg

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Subjective anxiety in behavioral approach tests (BAT) 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). change from T1 (baseline /study start) to T4 (immediately after treatment)
Secondary Subjective anxiety symptoms (Follow-Up) 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 T28 (6 months follow-up)
Secondary Subjective anxiety in behavioral approach tests (BAT) (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). change from T1 (baseline /study start) to T28 (6 months follow-up)
See also
  Status Clinical Trial Phase
Recruiting NCT04977544 - Virtual Reality Exposure Therapy in the Intensive Treatment of Social Anxiety Disorder N/A
Completed NCT03658252 - Efficacy of Targeted Intervention for Topical Steroid Phobia. N/A
Completed NCT03655262 - Treating Phobia With Multivoxel Neuro-reinforcement N/A
Completed NCT00451750 - Cortisol in the Treatment of Phobias N/A
Not yet recruiting NCT06420557 - Unconscious Reduction of Fear Through Decoded Neuro-Reinforcement N/A
Recruiting NCT03528109 - Improving Access to Child Anxiety Treatment N/A
Not yet recruiting NCT03813823 - Biobehavioral Correlates of Acute Phobic Fear
Completed NCT02810171 - Dimensional Brain Behavior Predictors of CBT Outcomes in Pediatric Anxiety N/A
Completed NCT02223767 - TMS Augmented Exposure Therapy N/A
Terminated NCT04019054 - TMS and Exposure Therapy N/A
Recruiting NCT03498599 - Neuroimaging of Pavlovian Fear Conditioning Processes in Patients With Pathological Anxiety N/A