TMS Augmented Exposure Therapy

NCT02223767 | Completed Results

• 2 other identifiers: Wuerzburg177/12098_MH
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Phobia

Keywords

TMS; virtual reality (VR); Exposure therapy; TMS augmentations of exposure therapy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Verum transcranial magnetic stimulation (TMS)

EXPERIMENTAL

10 Hz TMS over medial prefrontal cortex

Device: Experimental: Verum TMS

Sham transcranial magnetic stimulation (TMS)

EXPERIMENTAL

10 Hz sham TMS over medial prefrontal cortex

Device: Experimental: Sham TMS

Interventions

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.

Verum transcranial magnetic stimulation (TMS)

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.

Sham transcranial magnetic stimulation (TMS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Criteria for a simple phobia: specific heights

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (1)

University hospital

Würzburg, 97080, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Phobic Disorders

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Prof. Dr. M Herrmann
• Organization: Universitätsklinikum Würzburg

Herrmann_m@ukw.de

093120176650

Study Officials

• Martin J. Herrmann, PhD

  University of Würzburg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: August 22, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: October 1, 2015
• Last Updated: August 2, 2023
• Results First Posted: August 2, 2023

Record last verified: 2023-08

Locations

DE (1)