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

NCT ID: NCT02321891

Last Updated: 2014-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment 1

NeuroConn DC Stimulator Plus, tDCS treatment protocol no 1

Group Type EXPERIMENTAL

NeuroConn DC Stimulator Plus, tDCS

Intervention Type DEVICE

transcranial electrical stimulation intervention with two experimental protocols

Treatment 2

NeuroConn DC Stimulator Plus, tDCS treatment protocol no 2

Group Type EXPERIMENTAL

NeuroConn DC Stimulator Plus, tDCS

Intervention Type DEVICE

transcranial electrical stimulation intervention with two experimental protocols

Interventions

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NeuroConn DC Stimulator Plus, tDCS

transcranial electrical stimulation intervention with two experimental protocols

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Eastern Finland

OTHER

Sponsor Role lead

Responsible Party

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Soili Lehto

Adjunct professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Soili M Lehto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Eastern Finland

Locations

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University of Eastern Finland

Kuopio, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Soili M Lehto, MD, PhD

Role: CONTACT

Phone: +358 44 717 2971

Email: [email protected]

Facility Contacts

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Soili M Lehto, MD, PhD

Role: primary

Other Identifiers

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OptES-Anx-pilot

Identifier Type: -

Identifier Source: org_study_id