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| ID | Type | Description | Link |
|---|---|---|---|
| PAN_VR | Other Identifier | Clinic for Psychiatry |
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| Name | Class |
|---|---|
| University of Wuerzburg | OTHER |
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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.
The following hypotheses are derived:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum TMS | Experimental | ITBS (intermittent Theta Burst Stimulation) over left frontal cortex |
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| Sham TMS | Sham Comparator | Sham TMS over left frontal cortex |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin J. Herrmann, PhD | University of Würzburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Martin J. Herrmann | Würzburg | 97080 | Germany |
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| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| C000719188 | Acrophobia |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| Sham TMS | Device | Sham stimulation with same protocol, but without magnetic stimulation |
|
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| 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) |
| 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) |