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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02223767
Other study ID # Wuerzburg177/12
Secondary ID 098_MH
Status Completed
Phase N/A
First received
Last updated
Start date August 2014
Est. completion date October 2015

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

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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date October 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.
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.

Locations

Country Name City State
Germany University hospital Wuerzburg

Sponsors (1)

Lead Sponsor Collaborator
Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
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 4 weeks
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 4 weeks
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Completed NCT02810171 - Dimensional Brain Behavior Predictors of CBT Outcomes in Pediatric Anxiety N/A
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