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

Phase 1

Completed

• Conditions: Bipolar Disorder
• Interventions: Device: Transcranial direct current stimulation (Eldith DC Stimulator)

• Registration Number: NCT01339598
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-19
• Study First Posted: 2011-04-20
• Study Start: 2011-09
• Primary Completion: 2014-12
• Status Verified: 2015-07
• Study Completion: 2015-10
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Transcranial direct current stimulation	Transcranial direct current stimulation (Eldith DC Stimulator)	-
Sham transcranial direct current stimulation	Transcranial direct current stimulation (Eldith DC Stimulator)	-
Different transcranial direct current stimulation montage	Transcranial direct current stimulation (Eldith DC Stimulator)	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of New South Wales; 🇦🇺 Sydney, New South Wales, Australia