PhobiaBEATNCT02223767

TMS Augmented Exposure Therapy

A study testing Experimental: Verum TMS in people with Phobia, run by Wuerzburg University Hospital at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Phobia
What is being tested?: Experimental: Verum TMS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 47 participants
Where: 1 siteGermany
Study dates: Aug 2014to Oct 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Criteria for a simple phobia: specific heights

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

University hospital
Würzburg, 97080

Other trials in Germany

About this study

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

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
Being tested: Experimental: Verum TMS, Experimental: Sham TMS
Keywords: TMS, virtual reality (VR), Exposure therapy, TMS augmentations of exposure therapy
Medical subject headings: Phobic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental: Verum TMSDevice
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 TMSDevice
Sham stimulation with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.

Study groups in NCT02223767
Study group	Role	What they receive
Verum transcranial magnetic stimulation (TMS)	Experimental	10 Hz TMS over medial prefrontal cortex Receives: Device: Experimental: Verum TMS
Sham transcranial magnetic stimulation (TMS)	Experimental	10 Hz sham TMS over medial prefrontal cortex Receives: Device: Experimental: Sham TMS

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Oct 2015

First posted22 Aug 2014 (estimated)
Study startAug 2014
Primary completionApr 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PhobiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02223767
Sponsor's protocol ID: Wuerzburg177/12
Other IDs: 098_MH
Acronym: BEAT
Status last verified: Aug 2023
First submitted: 20 Aug 2014
Last updated: 2 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Phobia trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment of Height Phobics
ClinicalTrials.gov ID: NCT02223767
Acronym / sponsor ID: BEAT / Wuerzburg177/12
Conditions: Phobia
Keywords: TMS, virtual reality (VR), Exposure therapy, TMS augmentations of exposure therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Wuerzburg University HospitalUniversity, hospital or other
Study start: Aug 2014
Primary completion: Apr 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 22 Aug 2014 (estimated)
Results: Posted 2 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Verum transcranial magnetic stimulation (TMS)	Experimental	Device: Experimental: Verum TMS10 Hz TMS over medial prefrontal cortex
Sham transcranial magnetic stimulation (TMS)	Experimental	Device: Experimental: Sham TMS10 Hz sham TMS over medial prefrontal cortex

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Criteria for a simple phobia: specific heights

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Experimental: Verum TMSIntensity 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.	Device	Verum transcranial magnetic stimulation (TMS)
Experimental: Sham TMSSham stimulation with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.	Device	Sham transcranial magnetic stimulation (TMS)

Primary outcome

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
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

Results and safety

Results posted to the registry on 2 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Verum TMS	24	20
Sham TMS	23	19

Primary outcome: Subjective Anxiety Symptoms

Time frame: 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Verum TMS n = 20	Sham TMS n = 19
Value	17.4 (15.3)	7.3 (11.6)

Verum TMS vs Sham TMS: p = 0.025, t-test, 1 sided

Primary outcome: Subjective Anxiety in Height Situation (BAT), Differences From Pre (Baseline) to Post Therapy (Week 4)

Time frame: 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Verum TMS n = 20	Sham TMS n = 19
Value	25.8 (25.4)	16.3 (13.2)

Verum TMS vs Sham TMS: p = 0.08, t-test, 1 sided

Adverse events

Time frame: 3 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Verum TMS	0 of 20 (0%)	8 of 20 (40%)	0 of 20
Sham TMS	0 of 19 (0%)	3 of 19 (15.8%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Martin J. Herrmann, PhD principal investigator

University of Würzburg

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: Verum TMS in people with Phobia, run by Wuerzburg University Hospital at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective Anxiety Symptoms (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02223767.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.