Transcranial Electrical Stimulation in the Treatment of Acute Anxiety Induced by Stressful Life Events: A Pilot Study

Study Overview
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Brief Summary
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The investigators examine the efficacy of two different transcranial direct current stimulation (tDCS) stimulation protocols in the treatment of acute anxiety in an open-label pilot study in patients who have faced severely stressful life events.

Detailed Description
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Transcranial direct current stimulation (tDCS) is a novel neuromodulation method that has been observed to be promising in treatment of psychiatric disorders such as depression. Nevertheless, knowledge related to the treatment of psychological stress and its main symptom, anxiety, is very scarce. The investigators examine the efficacy of two different transcranial direct current stimulation (tDCS) stimulation protocols in the treatment of acute anxiety in an open-label pilot study in patients who have faced severely stressful life events.

Official Title
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Optimizing Electrical Stimulation for Clinical Applications (the OptES Study): Severe Psychological Stress - a Pilot Study (OptES-Stress-pilot)

Conditions
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Anxiety

Intervention / Treatment
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* Device: NeuroConn DC Stimulator Plus tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 years Naïve to tDCS Right-handed Impact of Event Scale Scores ≥ 30 Exclusion Criteria: Metal implants inside skull or eye Severe skin lesions at the electrode placement area History of epilepsy or previous seizures Pregnant or breast-feeding Pacemaker History of intracerebral bleeding during the past six months Major psychiatric conditions according to the Structured Clinical Interview for DSM-IV Disorders, i.e., Lifetime diagnoses of bipolar mood disorder or psychotic disorder DSM-IV diagnosis for one or more of the following conditions during the past six months: unipolar mood disorder, anxiety disorders, eating disorders, or substance dependence/abuse. Use of psychotropic medication (i.e., antipsychotic and antidepressant medications, mood stabilizers, psychostimulants, hypnotics and tranquilizers) during the past six months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1<br>NeuroConn DC Stimulator Plus tDCS treatment protocol no 1 | Device: NeuroConn DC Stimulator Plus tDCS<br>* transcranial electrical stimulation intervention with two experimental protocols<br>|
| Experimental: Treatment 2<br>NeuroConn DC Stimulator Plus tDCS treatment protocol no 1 | Device: NeuroConn DC Stimulator Plus tDCS<br>* transcranial electrical stimulation intervention with two experimental protocols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Event Scale (Change in scores of event-related anxiety) | Change in scores of event-related anxiety | 12 days |