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

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ClinicalTrials.gov Identifier: NCT01339598
Recruitment Status : Completed
First Posted : April 20, 2011
Last Update Posted : November 3, 2015
Sponsor:
Information provided by:
The University of New South Wales

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Device: Transcranial direct current stimulation (Eldith DC Stimulator) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Study Start Date : September 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Sham Comparator: Sham transcranial direct current stimulation Device: Transcranial direct current stimulation (Eldith DC Stimulator)
Eldith DC Stimulator (NeuroConn GmbH, Germany)

Active Comparator: Transcranial direct current stimulation Device: Transcranial direct current stimulation (Eldith DC Stimulator)
Eldith DC Stimulator (NeuroConn GmbH, Germany)

Active Comparator: Different transcranial direct current stimulation montage Device: Transcranial direct current stimulation (Eldith DC Stimulator)
Eldith DC Stimulator (NeuroConn GmbH, Germany)




Primary Outcome Measures :
  1. Total correct responses. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339598


Locations
Australia, New South Wales
University of New South Wales
Sydney, New South Wales, Australia, 2031
Sponsors and Collaborators
The University of New South Wales

Responsible Party: Dr Donel Martin, University of New South Wales
ClinicalTrials.gov Identifier: NCT01339598     History of Changes
Other Study ID Numbers: HREC 11065
First Posted: April 20, 2011    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Bipolar Disorder
Cognitive Dysfunction
Bipolar and Related Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders