Transcranial Electrical Stimulation in the Treatment of Acute Anxiety Induced by Stressful Life Events: A Pilot Study
OptesStressP
Optimizing Electrical Stimulation for Clinical Applications (the OptES Study): Severe Psychological Stress - a Pilot Study (OptES-Stress-pilot)
1 other identifier
interventional
14
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable anxiety
Started Jan 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2014
CompletedFirst Posted
Study publicly available on registry
December 19, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedDecember 19, 2014
December 1, 2014
11 months
December 16, 2014
December 18, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Impact of Event Scale (Change in scores of event-related anxiety)
Change in scores of event-related anxiety
12 days
Study Arms (2)
Treatment 1
EXPERIMENTALNeuroConn DC Stimulator Plus tDCS treatment protocol no 1
Treatment 2
EXPERIMENTALNeuroConn DC Stimulator Plus tDCS treatment protocol no 1
Interventions
transcranial electrical stimulation intervention with two experimental protocols
Eligibility Criteria
You may qualify if:
- Age 18-65 years
- Naïve to tDCS
- Right-handed
- Impact of Event Scale Scores ≥ 30
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Soili M Lehto, MD, PhD
University of Eastern Finland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Adjunct professor
Study Record Dates
First Submitted
December 16, 2014
First Posted
December 19, 2014
Study Start
January 1, 2015
Primary Completion
December 1, 2015
Study Completion
March 1, 2016
Last Updated
December 19, 2014
Record last verified: 2014-12