TMS Augmented Exposure Therapy

Study Overview
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Brief Summary
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This study investigates the beneficial effects of prefrontal brain stimulation (with a facilitating TMS protocol) before exposure therapy in acrophobic patients. The two exposure sessions were realized in virtual reality. Before and after therapy, the phobic symptoms were measured on a subjective, behavioral and physiological level. The placebo-controlled single blinded study includes 50 phobic patients, which were randomized into verum or sham TMS.

Official Title
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Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment of Height Phobics

Conditions
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Phobia

Intervention / Treatment
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* Device: Experimental: Verum TMS
* Device: Experimental: Sham TMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Criteria for a simple phobia: specific heights Exclusion Criteria: Objective tinnitus Involvement in psychiatric treatments Clinically relevant psychiatric comorbidity Clinically relevant unstable internal or neurological comorbidity History of or evidence of significant brain malformation or neoplasm, head injury Cerebral vascular events Neurodegenerative disorder affecting the brain or prior brain surgery Metal objects in and around body that can not be removed Pregnancy Alcohol or drug abuse history of seizures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum transcranial magnetic stimulation (TMS)<br>10 Hz TMS over medial prefrontal cortex | Device: Experimental: Verum TMS<br>* Intensity of 100 % of the resting motor threshold with 10 Hz and intertrial interval (ITI) of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.<br>|
| Experimental: Sham transcranial magnetic stimulation (TMS)<br>10 Hz sham TMS over medial prefrontal cortex | Device: Experimental: Sham TMS<br>* Sham stimulation with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Anxiety Symptoms | Change in anxiety questionaire (Agoraphobia Questionaire (AQ), subscale anxiety) from pre (baseline) to post therapy (week 4). The range of the scale is from 0 to 120. Higher values indicate higher anxiety symptoms. For the calculated changes from pre to post this means, that more negative values indicate higher symptom reductions | 4 weeks | 
| Subjective Anxiety in Height Situation (BAT), Differences From Pre (Baseline) to Post Therapy (Week 4) | real life anxiety measurement by an behavioral approach test. Ratings on a 0-100 scale. Higher values indicate higher anxiety | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TMS, virtual reality (VR), Exposure therapy, TMS augmentations of exposure therapy