A Pilot Study to Determine a Candidate Protocol for Transcranial Electrical Stimulation in the Treatment of Anxiety

Anxiety Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02321891
• Other study ID #: OptES-Anx-pilot
• Status: Recruiting
• Phase: N/A
• First received: December 9, 2014
• Last updated: December 16, 2014
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: University of Eastern Finland
• Contact: Soili M Lehto, MD, PhD
• Phone: +358 44 717 2971
• Email: soili.lehto[@]kuh.fi
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65 years

• Naïve to tDCS

• Right-handed

• Beck Anxiety Scores >= 26

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

• Lifetime DSM-IV diagnosis of bipolar mood disorder or psychotic disorder

• DSM-IV diagnosis for substance abuse or dependence during the past six months

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Device:
• NeuroConn DC Stimulator Plus, tDCS
transcranial electrical stimulation intervention with two experimental protocols

Locations

Country	Name	City	State
Finland	University of Eastern Finland	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Anxiety Inventory	change in scores of anxiety	12 days	No