Back to resultsTranscranial Electrical Stimulation in the Treatment of Acute Anxiety Induced by Stressful Life Events: A Pilot Study (OptesStressP)
Primary Purpose
Anxiety
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NeuroConn DC Stimulator Plus tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treatment 1
Treatment 2
Arm Description
NeuroConn DC Stimulator Plus tDCS treatment protocol no 1
NeuroConn DC Stimulator Plus tDCS treatment protocol no 1
Outcomes
Primary Outcome Measures
Impact of Event Scale (Change in scores of event-related anxiety)
Change in scores of event-related anxiety
Secondary Outcome Measures
Full Information
NCT ID
NCT02320370
First Posted
December 16, 2014
Last Updated
December 18, 2014
Sponsor
University of Eastern Finland
1. Study Identification
Unique Protocol Identification Number
NCT02320370
Brief Title
Transcranial Electrical Stimulation in the Treatment of Acute Anxiety Induced by Stressful Life Events: A Pilot Study
Acronym
OptesStressP
Official Title
Optimizing Electrical Stimulation for Clinical Applications (the OptES Study): Severe Psychological Stress - a Pilot Study (OptES-Stress-pilot)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Eastern Finland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment 1
Arm Type
Experimental
Arm Description
NeuroConn DC Stimulator Plus tDCS treatment protocol no 1
Arm Title
Treatment 2
Arm Type
Experimental
Arm Description
NeuroConn DC Stimulator Plus tDCS treatment protocol no 1
Intervention Type
Device
Intervention Name(s)
NeuroConn DC Stimulator Plus tDCS
Intervention Description
transcranial electrical stimulation intervention with two experimental protocols
Primary Outcome Measure Information:
Title
Impact of Event Scale (Change in scores of event-related anxiety)
Description
Change in scores of event-related anxiety
Time Frame
12 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soili M Lehto, MD, PhD
Phone
+358 44 717 2971
Email
soili.lehto@kuh.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soili M Lehto, MD, PhD
Organizational Affiliation
University of Eastern Finland
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Transcranial Electrical Stimulation in the Treatment of Acute Anxiety Induced by Stressful Life Events: A Pilot Study
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