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| ID | Type | Description | Link |
|---|---|---|---|
| 098_MH | Other Identifier | Clinic for Psychiatry |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum transcranial magnetic stimulation (TMS) | Experimental | 10 Hz TMS over medial prefrontal cortex |
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| Sham transcranial magnetic stimulation (TMS) | Experimental | 10 Hz sham TMS over medial prefrontal cortex |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Verum TMS | Device | 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. |
| 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 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Martin J. Herrmann, PhD | University of Würzburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital | Würzburg | 97080 | Germany |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Verum TMS | 10 Hz transcranial magnetic stimulation (TMS) over medial prefrontal cortex Experimental: Verum TMS: 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. |
| FG001 | Sham TMS | 10 Hz sham TMS over medial prefrontal cortex Experimental: Sham TMS: Sham stimulation with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Verum TMS | 10 Hz TMS over medial prefrontal cortex Experimental: Verum TMS: Intensity of 100 % of the resting motor threshold with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s. |
| BG001 | Sham TMS |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
3 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Verum TMS | 10 Hz TMS over medial prefrontal cortex Experimental: Verum TMS: Intensity of 100 % of the resting motor threshold with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. M Herrmann | Universitätsklinikum Würzburg | 093120176650 | Herrmann_m@ukw.de |
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| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| Experimental: Sham TMS | Device | Sham stimulation with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s. |
|
10 Hz sham TMS over medial prefrontal cortex
Experimental: Sham TMS: Sham stimulation with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
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|
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| 0 |
| 20 |
| 0 |
| 20 |
| 8 |
| 20 |
| EG001 | Sham TMS | 10 Hz sham TMS over medial prefrontal cortex Experimental: Sham TMS: Sham stimulation with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s. | 0 | 19 | 0 | 19 | 3 | 19 |
| drowsiness | Nervous system disorders | Non-systematic Assessment |
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| neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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