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

NCT ID: NCT02320370

Last Updated: 2014-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-03-31

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.

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment 1

NeuroConn DC Stimulator Plus tDCS treatment protocol no 1

Group Type EXPERIMENTAL

NeuroConn DC Stimulator Plus tDCS

Intervention Type DEVICE

transcranial electrical stimulation intervention with two experimental protocols

Treatment 2

NeuroConn DC Stimulator Plus tDCS treatment protocol no 1

Group Type EXPERIMENTAL

NeuroConn DC Stimulator Plus tDCS

Intervention Type DEVICE

transcranial electrical stimulation intervention with two experimental protocols

Interventions

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NeuroConn DC Stimulator Plus tDCS

transcranial electrical stimulation intervention with two experimental protocols

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Eastern Finland

OTHER

Sponsor Role lead

Responsible Party

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Soili Lehto

Adjunct professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Soili M Lehto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Eastern Finland

Central Contacts

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Soili M Lehto, MD, PhD

Role: CONTACT

Phone: +358 44 717 2971

Email: [email protected]

Other Identifiers

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OptES-Stress-pilot

Identifier Type: -

Identifier Source: org_study_id