Phobia
Conditions
Keywords
TMS, virtual reality (VR), Exposure therapy, TMS augmentations of exposure therapy
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.
Interventions
DEVICEExperimental: 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.
DEVICEExperimental: Sham TMS
Sham stimulation with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.
Sponsors
Wuerzburg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Anxiety Symptoms | 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) | 4 weeks | real life anxiety measurement by an behavioral approach test. Ratings on a 0-100 scale. Higher values indicate higher anxiety |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Verum TMS 10 Hz TMS over medial prefrontal cortex
Experimental: Verum TMS: Intensity of 100 % of the resting motor threshold with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s. | 20 |
| Sham TMS 10 Hz sham TMS over medial prefrontal cortex
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. | 19 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Verum TMS | Sham TMS | Total |
|---|---|---|---|
| Age, Continuous | 43.2 years STANDARD_DEVIATION 12.6 | 46.6 years STANDARD_DEVIATION 13.7 | 44.9 years STANDARD_DEVIATION 13.1 |
| Region of Enrollment Germany | 20 participants | 19 participants | 39 participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 8 / 20 | 3 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 |
Outcome results
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
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Verum TMS | Subjective Anxiety in Height Situation (BAT), Differences From Pre (Baseline) to Post Therapy (Week 4) | 25.8 units on a scale | Standard Deviation 25.4 |
| Sham TMS | Subjective Anxiety in Height Situation (BAT), Differences From Pre (Baseline) to Post Therapy (Week 4) | 16.3 units on a scale | Standard Deviation 13.2 |
p-value: 0.08t-test, 1 sided
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
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Verum TMS | Subjective Anxiety Symptoms | 17.4 units on a scale | Standard Deviation 15.3 |
| Sham TMS | Subjective Anxiety Symptoms | 7.3 units on a scale | Standard Deviation 11.6 |
p-value: 0.025t-test, 1 sided