search
Back to results

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

Primary Purpose

Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
NeuroConn DC Stimulator Plus, tDCS
Sponsored by
University of Eastern Finland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Eastern FinlandRecruiting

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 2

Outcomes

Primary Outcome Measures

Beck Anxiety Inventory
change in scores of anxiety

Secondary Outcome Measures

Full Information

First Posted
December 9, 2014
Last Updated
December 16, 2014
Sponsor
University of Eastern Finland
search

1. Study Identification

Unique Protocol Identification Number
NCT02321891
Brief Title
A Pilot Study to Determine a Candidate Protocol for Transcranial Electrical Stimulation in the Treatment of Anxiety
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
December 2015 (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 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.

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 2
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
Beck Anxiety Inventory
Description
change in scores of 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 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
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
Facility Information:
Facility Name
University of Eastern Finland
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soili M Lehto, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs