AnxietyNCT02321891
A Pilot Study to Determine a Candidate Protocol for Transcranial Electrical Stimulation in the Treatment of Anxiety
A study testing NeuroConn DC Stimulator Plus, tDCS in people with Anxiety, run by University of Eastern Finland at 1 site in Finland.
Trial summary
The investigators examine the efficacy of two different transcranial direct current stimulation (tDCS) stimulation protocols in the treatment of anxiety in an open-label pilot study. 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
- 1 siteFinland
- Study dates
- Dec 2014to Dec 2015
- 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
- Beck Anxiety Scores >= 26
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
- Lifetime DSM-IV diagnosis of bipolar mood disorder or psychotic disorder
- DSM-IV diagnosis for substance abuse or dependence during the past six months
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
University of Eastern Finland
Kuopio, 70211
Soili M Lehto, MD, PhD
About this study
Official title: Optimizing Transcranial Electrical Stimulation for Clinical Applications (the OptES Study): A Pilot Study to Determine a Candidate Protocol for Treatment of Anxiety (OptES-Anx)
The investigators examine the efficacy of two different transcranial direct current stimulation (tDCS) stimulation protocols in the treatment of anxiety in an open-label pilot study.
Read the detailed description
The investigators examine the efficacy of two different transcranial direct current stimulation (tDCS) stimulation protocols in the treatment of anxiety in an open-label pilot study in patients with chronic pain. The investigators also seek to detect autonomic nervous system changes induced by the tDCS, and develop new methods for the measurement of autonomic nervous system functions.
- 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 2 Receives: Device: NeuroConn DC Stimulator Plus, tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Inventory
change in scores of 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 posted22 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (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
- NCT02321891
- Sponsor's protocol ID
- OptES-Anx-pilot
- Status last verified
- Dec 2014
- First submitted
- 9 Dec 2014
- Last updated
- 22 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Transcranial Electrical Stimulation for Clinical Applications (the OptES Study): A Pilot Study to Determine a Candidate Protocol for Treatment of Anxiety (OptES-Anx)
- ClinicalTrials.gov ID
- NCT02321891
- Acronym / sponsor ID
- OptES-Anx-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
- Dec 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 22 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 anxiety in an open-label pilot study.
Detailed description
The investigators examine the efficacy of two different transcranial direct current stimulation (tDCS) stimulation protocols in the treatment of anxiety in an open-label pilot study in patients with chronic pain. The investigators also seek to detect autonomic nervous system changes induced by the tDCS, and develop new methods for the measurement of autonomic nervous system functions.
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 2 |
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
- Beck Anxiety Scores >= 26
Key exclusion criteria (8 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
Beck Anxiety Inventory
Time frame: 12 days
change in scores of anxiety
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 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
1 site in 1 country: see every site and its status.
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 at 1 site in 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 8 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 22 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Beck Anxiety Inventory (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 22 Dec 2014.