AnxietyOptesStressPNCT02320370
Transcranial Electrical Stimulation in the Treatment of Acute Anxiety Induced by Stressful Life Events: A Pilot Study
A study testing NeuroConn DC Stimulator Plus tDCS in people with Anxiety, run by University of Eastern Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety
- What is being tested?
- NeuroConn DC Stimulator Plus tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Naïve to tDCS
- Right-handed
- Impact of Event Scale Scores ≥ 30
Who cannot join
- 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
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- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Optimizing Electrical Stimulation for Clinical Applications (the OptES Study): Severe Psychological Stress - a Pilot Study (OptES-Stress-pilot)
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- NeuroConn DC Stimulator Plus tDCS
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroConn DC Stimulator Plus tDCSDevice
transcranial electrical stimulation intervention with two experimental protocols
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | NeuroConn DC Stimulator Plus tDCS treatment protocol no 1 Receives: Device: NeuroConn DC Stimulator Plus tDCS |
| Treatment 2 | Experimental | NeuroConn DC Stimulator Plus tDCS treatment protocol no 1 Receives: Device: NeuroConn DC Stimulator Plus tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Event Scale (Change in scores of event-related anxiety)
Change in scores of event-related anxiety
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soili Lehto, University of Eastern Finland
- Investigators
- Soili M Lehto, MD, PhD, Principal investigator, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320370
- Sponsor's protocol ID
- OptES-Stress-pilot
- Acronym
- OptesStressP
- Status last verified
- Dec 2014
- First submitted
- 16 Dec 2014
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Electrical Stimulation for Clinical Applications (the OptES Study): Severe Psychological Stress - a Pilot Study (OptES-Stress-pilot)
- ClinicalTrials.gov ID
- NCT02320370
- Acronym / sponsor ID
- OptesStressP / OptES-Stress-pilot
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Device: NeuroConn DC Stimulator Plus tDCSNeuroConn DC Stimulator Plus tDCS treatment protocol no 1 |
| Treatment 2 | Experimental | Device: NeuroConn DC Stimulator Plus tDCSNeuroConn DC Stimulator Plus tDCS treatment protocol no 1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years
- Naïve to tDCS
- Right-handed
- Impact of Event Scale Scores ≥ 30
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroConn DC Stimulator Plus tDCStranscranial electrical stimulation intervention with two experimental protocols | Device | Treatment 1, Treatment 2 |
Primary outcome
Impact of Event Scale (Change in scores of event-related anxiety)
Time frame: 12 days
Change in scores of event-related anxiety
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soili M Lehto, MD, PhD principal investigator
University of Eastern Finland
Questions about this trial
What is this clinical trial studying?
A study testing NeuroConn DC Stimulator Plus tDCS in people with Anxiety, run by University of Eastern Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soili M Lehto, MD, PhD (+358 44 717 2971, soili.lehto@kuh.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Event Scale (Change in scores of event-related anxiety) (time frame: 12 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2014.