Home-Administered Trial of Direct Current Stimulation

NCT ID: NCT02894736

Last Updated: 2018-08-02

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

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-07-31

Brief Summary

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Transcranial Direct Current Stimulation (tDCS) is a novel non-invasive brain stimulation treatment that is effective with no significant side effects. It can potentially be self-administered by patients in their own homes with remote monitoring, substantially reducing treatment costs and increasing accessibility, including to remote areas. This study will evaluate the feasibility and efficacy of home-administered tDCS treatment for depression.

Detailed Description

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Conditions

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Major Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active tDCS

Soterix tDCS machine is used to administer active stimulation

Group Type EXPERIMENTAL

Soterix tDCS machine

Intervention Type DEVICE

Soterix tDCS machine - miniCT supervised neuromodulation system

Interventions

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Soterix tDCS machine

Soterix tDCS machine - miniCT supervised neuromodulation system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject meets criteria for a DSM-IV Major Depressive Episode, lasting more than 4 weeks
* Total MADRS score ≥ 20

Exclusion Criteria

* Diagnosis of any DSM-IV psychotic disorder
* History of drug or alcohol abuse or dependence in the preceding 3 months
* High suicide risk
* Clinically defined neurological disorder or insult
* Metal in the cranium or skull defects
* Skin lesions on the scalp (e.g. cuts, abrasions, rashes) at the proposed electrode sites
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of New South Wales

OTHER

Sponsor Role lead

Responsible Party

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Colleen Loo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angelo Alonzo, BSc(Hons)/BA, PhD

Role: PRINCIPAL_INVESTIGATOR

University of New South Wales / Black Dog Institute

Locations

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Black Dog Institute

Randwick, Sydney, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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HC15010

Identifier Type: -

Identifier Source: org_study_id

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