PhobiaNCT04782570
Psychotherapy of Anxiety Disorders With Noninvasive Brain Stimulation - Using Virtual Reality
A study testing Verum TMS in people with Phobia, run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
The aim of the study is to transfer the rTMS stimulation protocol by Raij et al. (2018) into a therapeutic setting to improve exposure therapy in acrophobic patients. The quasi-randomized, placebo-controlled and double-blinded study will include 88 patients with height phobia (according to DSM 5). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Phobia
- What is being tested?
- Verum TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteGermany
- Study dates
- 12 May 2021to 28 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Acrophobia (according to DSM-5)
- Right handed
- German native speaker
- Written informed consent
Who cannot join
- Neurological and/or severe physical illnesses
- Comorbid Axis I disorder (other than phobias)
- Pretreated phobia of heights
- Use of tricyclic antidepressants, antipsychotics, or other substances that increase cerebral seizure susceptibility
- Craniocerebral injuries, head surgery
- Epileptic seizures, or family history of epilepsy
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- Metal parts in the head area
- Cardiac pacemakers
- Infusion pumps
- Heart diseases
- Increased intracranial pressure
- Pregnancy
- Cochlear implants
- Tattoos (done before the year 2000)
- Piercings (if not completely removable)
- Permanent make-up
- Nicotine or pain patches
- other MRI contraindications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nicht-invasive Hirnstimulation in Der Psychotherapie Von Angsterkrankungen
The aim of the study is to transfer the rTMS stimulation protocol by Raij et al. (2018) into a therapeutic setting to improve exposure therapy in acrophobic patients. The quasi-randomized, placebo-controlled and double-blinded study will include 88 patients with height phobia (according to DSM 5). All participants will perform two exposure sessions in virtual reality (VR). Before exposure therapy, one group will receive verum rTMS of the left frontal cortex, which is indirectly functionally linked to the ventromedial prefrontal cortex (Raij et al., 2018). The control group will receive sham stimulation. A structural MRI and a TMS navigation system will be used for precise localization of the left FC. Anxiety symptoms will be measured using subjective ratings (e.g. Acrophobia Questionnaire) and the behavioural approach task (BAT) in VR and in real life before and after the treatment, and at 6 months follow-up. Furthermore, blood samples will be collected before rTMS and after exposure treatment to assess epigenetic and gene expression based changes.
Read the detailed description
The following hypotheses are derived:
- Patients with acrophobia, who receive an active rTMS of the left FC before VRET, show a significantly stronger reduction of phobic symptoms immediately after exposure therapy, compared to the sham stimulation group.
- Patients with acrophobia, who receive an active rTMS of the left FC before VRET, show a significantly greater increase in approach behavior and significantly less distress during the BAT immediately after exposure therapy, compared to the sham stimulation group.
- The postulated differences in hypotheses 1 and 2 are still detectable at follow-up after 6 months.
- Conditions
- Phobia
- Being tested
- Verum TMS, Sham TMS
- Keywords
- VR, Exposure therapy, Acrophobia, rTMS, PFC
- Medical subject headings
- Phobic Disorders, Acrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum TMSDevice
Also called Cool-B70 A/P, MagPro X100, MagVenture®, Denmark
Intensity of 100% of the resting motor threshold with iTBS. 600 stimuli applied in bursts of three pulses at 50 Hz given every 200 ms. iTBS will be applied 20 times for 2 s every 10 s.
Sham TMSDevice
Also called Cool-B70 A/P, MagPro X100,, MagVenture®, Denmark
Sham stimulation with same protocol, but without magnetic stimulation
| Study group | Role | What they receive |
|---|---|---|
| Verum TMS | Experimental | ITBS (intermittent Theta Burst Stimulation) over left frontal cortex Receives: Device: Verum TMS |
| Sham TMS | Sham comparator | Sham TMS over left frontal cortex Receives: Device: Sham TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective anxiety symptoms
Acrophobia Questionnaire (Cohen, 1977) with two subscales: 1) degree of anxiety (ACRO) and 2) degree of avoidance (AVOI) in height-related situations.
Measured: change from T1 (baseline /study start) to T4 (immediately after treatment)
Secondary outcomes (3)
Subjective anxiety in behavioral approach tests (BAT)
anxiety measurement by a behavioral approach test (BAT) in virtual reality (glass elevator on the outside of an high-rise building, height up to 150m) and in real life (open stairwell height up to 11,6m).
Measured: change from T1 (baseline /study start) to T4 (immediately after treatment)
Subjective anxiety symptoms (Follow-Up)
Acrophobia Questionnaire (Cohen, 1977) with two subscales: 1) degree of anxiety (ACRO) and 2) degree of avoidance (AVOI) in height-related situations.
Measured: change from T1 (baseline/ study start) to T28 (6 months follow-up)
Subjective anxiety in behavioral approach tests (BAT) (Follow-Up)
anxiety measurement by a behavioral approach test (BAT) in virtual reality (glass elevator on the outside of an high-rise building, height up to 150m) and in real life (open stairwell height up to 11,6m).
Measured: change from T1 (baseline /study start) to T28 (6 months follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start12 May 2021
- Primary completion27 Sep 2022
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wuerzburg
- Responsible party
- Sponsor
- Investigators
- Martin J. Herrmann, PhD, Principal investigator, University of Würzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782570
- Sponsor's protocol ID
- Wuerzburg45/20-am
- Other IDs
- PAN_VR
- Status last verified
- Aug 2023
- First submitted
- 23 Feb 2021
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Nicht-invasive Hirnstimulation in Der Psychotherapie Von Angsterkrankungen
- ClinicalTrials.gov ID
- NCT04782570
- Acronym / sponsor ID
- Wuerzburg45/20-am
- Conditions
- Phobia
- Keywords
- VR, Exposure therapy, Acrophobia, rTMS, PFC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- University of Wuerzburg
- Study start
- 12 May 2021 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to transfer the rTMS stimulation protocol by Raij et al. (2018) into a therapeutic setting to improve exposure therapy in acrophobic patients. The quasi-randomized, placebo-controlled and double-blinded study will include 88 patients with height phobia (according to DSM 5). All participants will perform two exposure sessions in virtual reality (VR). Before exposure therapy, one group will receive verum rTMS of the left frontal cortex, which is indirectly functionally linked to the ventromedial prefrontal cortex (Raij et al., 2018). The control group will receive sham stimulation. A structural MRI and a TMS navigation system will be used for precise localization of the left FC. Anxiety symptoms will be measured using subjective ratings (e.g. Acrophobia Questionnaire) and the behavioural approach task (BAT) in VR and in real life before and after the treatment, and at 6 months follow-up. Furthermore, blood samples will be collected before rTMS and after exposure treatment to assess epigenetic and gene expression based changes.
Detailed description
The following hypotheses are derived:
- Patients with acrophobia, who receive an active rTMS of the left FC before VRET, show a significantly stronger reduction of phobic symptoms immediately after exposure therapy, compared to the sham stimulation group.
- Patients with acrophobia, who receive an active rTMS of the left FC before VRET, show a significantly greater increase in approach behavior and significantly less distress during the BAT immediately after exposure therapy, compared to the sham stimulation group.
- The postulated differences in hypotheses 1 and 2 are still detectable at follow-up after 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum TMS | Experimental | Device: Verum TMSITBS (intermittent Theta Burst Stimulation) over left frontal cortex |
| Sham TMS | Sham comparator | Device: Sham TMSSham TMS over left frontal cortex |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acrophobia (according to DSM-5)
- Right handed
- German native speaker
- Written informed consent
Key exclusion criteria (18 listed)
- Neurological and/or severe physical illnesses
- Comorbid Axis I disorder (other than phobias)
- Pretreated phobia of heights
- Use of tricyclic antidepressants, antipsychotics, or other substances that increase cerebral seizure susceptibility
- Craniocerebral injuries, head surgery
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 |
|---|---|---|
| Verum TMSAlso: Cool-B70 A/P, MagPro X100, MagVenture®, DenmarkIntensity of 100% of the resting motor threshold with iTBS. 600 stimuli applied in bursts of three pulses at 50 Hz given every 200 ms. iTBS will be applied 20 times for 2 s every 10 s. | Device | Verum TMS |
| Sham TMSAlso: Cool-B70 A/P, MagPro X100,, MagVenture®, DenmarkSham stimulation with same protocol, but without magnetic stimulation | Device | Sham TMS |
Primary outcome
Subjective anxiety symptoms
Time frame: change from T1 (baseline /study start) to T4 (immediately after treatment)
Acrophobia Questionnaire (Cohen, 1977) with two subscales: 1) degree of anxiety (ACRO) and 2) degree of avoidance (AVOI) in height-related situations.
3 secondary outcomes
Subjective anxiety in behavioral approach tests (BAT)
Time frame: change from T1 (baseline /study start) to T4 (immediately after treatment)
Subjective anxiety symptoms (Follow-Up)
Time frame: change from T1 (baseline/ study start) to T28 (6 months follow-up)
Subjective anxiety in behavioral approach tests (BAT) (Follow-Up)
Time frame: change from T1 (baseline /study start) to T28 (6 months follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
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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 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 4 inclusion and 18 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: change from T1 (baseline /study start) to T4 (immediately after treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.