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

Bipolar Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01339598
• Other study ID #: HREC 11065
• Status: Completed
• Phase: Phase 1
• First received: April 7, 2011
• Last updated: November 2, 2015
• Start date: September 2011
• Est. completion date: October 2015

Study information

• Verified date: July 2015
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods Administration.
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

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

Locations

Country	Name	City	State
Australia	University of New South Wales	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
The University of New South Wales

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total correct responses.	Total number of correct responses on each task in each session.	Across each session (approximately 1 hour in duration), with each session conducted at least 1 week apart.	No