Home-Administered Trial of Direct Current Stimulation | NCT02894736

Studies
Home-Administered Trial of Direct Current Stimulation

NCT02894736

Sponsor

The University of New South Wales

Status

Completed

Last Update Posted

Aug 2, 2018Actual

Enrollment

34Actual

Phase

Not Applicable

Conditions

Major Depression

Interventions

Soterix tDCS machine

Countries

Australia

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

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Mar 2018Actual

Completion Date

Jul 2018Actual

First Submitted Date

Sep 5, 2016

First Submission Date that Met QC Criteria

Sep 5, 2016

First Posted Date

Sep 9, 2016Estimated

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

Aug 1, 2018

Last Update Posted Date

Aug 2, 2018Actual

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

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

Not provided

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

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active tDCS	Experimental	Soterix tDCS machine is used to administer active stimulation	Device: Soterix tDCS machine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Soterix tDCS machine	Device	Soterix tDCS machine - miniCT supervised neuromodulation system	Active tDCS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Montgomery Asberg Depression Rating Scale for Depression (MADRS)		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Angelo Alonzo, BSc(Hons)/BA, PhD	University of New South Wales / Black Dog Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Black Dog Institute		Randwick, Sydney	New South Wales	2031	Australia

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided