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

Not Applicable

• Conditions: Anxiety
• Interventions: Device: NeuroConn DC Stimulator Plus tDCS

• Registration Number: NCT02320370
• Lead Sponsor: University of Eastern Finland

Brief Summary

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

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.

Study Timeline

• Status Verified: 2014-12
• Study First Submitted: 2014-12-16
• Study First Submitted QC: 2014-12-18
• Last Update Submitted: 2014-12-18
• Study First Posted: 2014-12-19
• Last Update Posted: 2014-12-19
• Study Start: 2015-01
• Primary Completion: 2015-12
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment 2	NeuroConn DC Stimulator Plus tDCS	NeuroConn DC Stimulator Plus tDCS treatment protocol no 1
Treatment 1	NeuroConn DC Stimulator Plus tDCS	NeuroConn DC Stimulator Plus tDCS treatment protocol no 1

Primary Outcome Measures

Name	Time	Method
Impact of Event Scale (Change in scores of event-related anxiety)	12 days	Change in scores of event-related anxiety