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

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Transcranial direct current stimulation (Eldith DC Stimulator)
Sponsored by
The University of New South Wales
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bipolar Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of New South Wales

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Arm Label

Sham transcranial direct current stimulation

Transcranial direct current stimulation

Different transcranial direct current stimulation montage

Arm Description

Outcomes

Primary Outcome Measures

Total correct responses.
Total number of correct responses on each task in each session.

Secondary Outcome Measures

Full Information

First Posted
April 7, 2011
Last Updated
November 2, 2015
Sponsor
The University of New South Wales
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1. Study Identification

Unique Protocol Identification Number
NCT01339598
Brief Title
Remediation of Cognitive Dysfunction in Euthymic Bipolar Disorder Patients Using Transcranial Direct Current Stimulation (tDCS)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The University of New South Wales

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham transcranial direct current stimulation
Arm Type
Sham Comparator
Arm Title
Transcranial direct current stimulation
Arm Type
Active Comparator
Arm Title
Different transcranial direct current stimulation montage
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (Eldith DC Stimulator)
Intervention Description
Eldith DC Stimulator (NeuroConn GmbH, Germany)
Primary Outcome Measure Information:
Title
Total correct responses.
Description
Total number of correct responses on each task in each session.
Time Frame
Across each session (approximately 1 hour in duration), with each session conducted at least 1 week apart.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
University of New South Wales
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia

12. IPD Sharing Statement

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

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