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Home-Administered Trial of Direct Current Stimulation

Not Applicable
Completed
Conditions
Major Depression
Interventions
Device: Soterix tDCS machine
Registration Number
NCT02894736
Lead Sponsor
The University of New South Wales
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 available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
34
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Active tDCSSoterix tDCS machineSoterix tDCS machine is used to administer active stimulation
Primary Outcome Measures
NameTimeMethod
Montgomery Asberg Depression Rating Scale for Depression (MADRS)6 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Black Dog Institute

🇦🇺

Randwick, Sydney, New South Wales, Australia

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