TMS Augmented Exposure Therapy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Phobia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Verum transcranial magnetic stimulation (TMS)

10 Hz TMS over medial prefrontal cortex

Group Type EXPERIMENTAL

Experimental: Verum TMS

Intervention Type 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.

Sham transcranial magnetic stimulation (TMS)

10 Hz sham TMS over medial prefrontal cortex

Group Type EXPERIMENTAL

Experimental: Sham TMS

Intervention Type DEVICE

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

Interventions

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Experimental: 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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No