NCT02321891

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 22, 2014

Status Verified

December 1, 2014

Enrollment Period

10 months

First QC Date

December 9, 2014

Last Update Submit

December 16, 2014

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

  • Beck Anxiety Inventory

    change in scores of anxiety

    12 days

Study Arms (2)

Treatment 1

EXPERIMENTAL

NeuroConn DC Stimulator Plus, tDCS treatment protocol no 1

Device: NeuroConn DC Stimulator Plus, tDCS

Treatment 2

EXPERIMENTAL

NeuroConn DC Stimulator Plus, tDCS treatment protocol no 2

Device: NeuroConn DC Stimulator Plus, tDCS

Interventions

NeuroConn DC Stimulator Plus, tDCSDEVICE

transcranial electrical stimulation intervention with two experimental protocols

Treatment 1Treatment 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years
  • Naïve to tDCS
  • Right-handed
  • Beck Anxiety Scores \>= 26

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Eastern Finland

Kuopio, 70211, Finland

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Soili M Lehto, MD, PhD

    University of Eastern Finland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Soili M Lehto, MD, PhD

CONTACT

+358 44 717 2971soili.lehto@kuh.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct professor

Study Record Dates

First Submitted

December 9, 2014

First Posted

December 22, 2014

Study Start

December 1, 2014

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

December 22, 2014

Record last verified: 2014-12

Locations

FI(1)