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

NCT ID: NCT01339598

Last Updated: 2015-11-03

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

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Sham transcranial direct current stimulation

Group Type SHAM_COMPARATOR

Transcranial direct current stimulation (Eldith DC Stimulator)

Intervention Type DEVICE

Eldith DC Stimulator (NeuroConn GmbH, Germany)

Transcranial direct current stimulation

Group Type ACTIVE_COMPARATOR

Transcranial direct current stimulation (Eldith DC Stimulator)

Intervention Type DEVICE

Eldith DC Stimulator (NeuroConn GmbH, Germany)

Different transcranial direct current stimulation montage

Group Type ACTIVE_COMPARATOR

Transcranial direct current stimulation (Eldith DC Stimulator)

Intervention Type DEVICE

Eldith DC Stimulator (NeuroConn GmbH, Germany)

Interventions

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Transcranial direct current stimulation (Eldith DC Stimulator)

Eldith DC Stimulator (NeuroConn GmbH, Germany)

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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University of New South Wales

Locations

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University of New South Wales

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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HREC 11065

Identifier Type: -

Identifier Source: org_study_id

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