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Completed

NCT Number: NCT02223767

TMS Augmented Exposure Therapy

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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Key information

Conditions

Phobia Anxiety Disorders Mental Disorders Phobic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital

Würzburg, 97080, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Subjective Anxiety Symptoms

    Time frame: 4 weeks

    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

  2. Subjective Anxiety in Height Situation (BAT), Differences From Pre (Baseline) to Post Therapy (Week 4)

    Time frame: 4 weeks

    real life anxiety measurement by an behavioral approach test. Ratings on a 0-100 scale. Higher values indicate higher anxiety

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Registry information

Official study title

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

Acronym: BEAT

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 22, 2014
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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