Home-Administered Trial of Direct Current Stimulation (HAT-DCS)

The University of New South Wales

Status: Completed

Conditions: Major Depression

Treatments: Device: Soterix tDCS machine

Study type: Interventional

Funder types: Other

Identifiers

NCT02894736

HC15010

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Active tDCS

Experimental group

Description:

Soterix tDCS machine is used to administer active stimulation

Treatment:

Device: Soterix tDCS machine