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Remediation of Cognitive Dysfunction in Euthymic Bipolar Disorder Patients Using Transcranial Direct Current Stimulation (tDCS)

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01339598
Enrollment
15
Registered
2011-04-20
Start date
2011-09-30
Completion date
2015-10-31
Last updated
2015-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Brief summary

This study aims to investigate the potential for Transcranial Direct Current Stimulation (tDCS) to enhance cognitive functioning in euthymic bipolar patients through comparing the effect of active or sham tDCS (placebo control) during the performance of two cognitive tasks. The investigators hypothesize that task performance will be improved with active relative to sham tDCS.

Interventions

DEVICETranscranial direct current stimulation (Eldith DC Stimulator)

Eldith DC Stimulator (NeuroConn GmbH, Germany)

Sponsors

The University of New South Wales
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Participants will be right-handed subjects aged 18-65 meeting DSM-IV diagnostic criteria for bipolar disorder, with no acute episodes of depression or mania within the previous 12 weeks * A score of ≤ 20 on the MADRS, and a score of ≤ 6 on the YMRS, who have been on a stable dose of mood stabiliser medications for at least 1 month.

Exclusion criteria

* Patients with high suicide risk * Co-morbid DSM-IV diagnosis of any psychotic disorder (current or within the last year), schizophrenia and schizoaffective disorder * Mental retardation * A history of drug or alcohol abuse or dependence within the last 3 months * Co-morbid attention deficit hyperactivity disorder (ADHD), or any neurological disorder * Recent stroke * Head injury * History of seizure, or who have had electroconvulsive therapy (ECT) within the 6 months preceding enrolment. * Participants will also be excluded if currently taking medications known to be associated with frank cognitive impairment (e.g., benzodiazepines).

Design outcomes

Primary

MeasureTime frameDescription
Total correct responses.Across each session (approximately 1 hour in duration), with each session conducted at least 1 week apart.Total number of correct responses on each task in each session.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026