A Pilot Study to Determine a Candidate Protocol for Trans... | NCT02321891

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

NCT02321891

Sponsor

University of Eastern Finland

Status

Unknown status

Last Update Posted

Dec 22, 2014Estimated

Enrollment

14Estimated

Phase

Not Applicable

Conditions

Anxiety

Interventions

NeuroConn DC Stimulator Plus, tDCS

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Oct 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Dec 9, 2014

First Submission Date that Met QC Criteria

Dec 16, 2014

First Posted Date

Dec 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2014

Last Update Posted Date

Dec 22, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Soili Lehto, Adjunct professor, University of Eastern FinlandPrincipal Investigator

Lead Sponsor

University of Eastern FinlandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
NeuroConn DC Stimulator Plus, tDCS	Device	transcranial electrical stimulation intervention with two experimental protocols	Treatment 1 Treatment 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Beck Anxiety Inventory	change in scores of anxiety	12 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Soili M Lehto, MD, PhD	Contact	+358 44 717 2971		soili.lehto@kuh.fi

Overall Officials

Name	Affiliation	Role
Soili M Lehto, MD, PhD	University of Eastern Finland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Eastern Finland	Recruiting	Kuopio		70211	Finland

Condition Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D065908	Transcranial Direct Current Stimulation

Ancestor Terms

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D003295	Convulsive Therapy
D013000	Psychiatric Somatic Therapies

Browse Leaves

Not provided

Browse Branches

Not provided