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

U

University of Eastern Finland

Status

Unknown

Conditions

Anxiety

Treatments

Device: NeuroConn DC Stimulator Plus tDCS

Study type

Interventional

Funder types

Other

Identifiers

NCT02320370
OptES-Stress-pilot

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

14 participants in 2 patient groups

Treatment 1
Experimental group
Description:
NeuroConn DC Stimulator Plus tDCS treatment protocol no 1
Treatment:
Device: NeuroConn DC Stimulator Plus tDCS
Treatment 2
Experimental group
Description:
NeuroConn DC Stimulator Plus tDCS treatment protocol no 1
Treatment:
Device: NeuroConn DC Stimulator Plus tDCS

Trial contacts and locations

0

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Central trial contact

Soili M Lehto, MD, PhD

Data sourced from clinicaltrials.gov

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