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

Study Overview
=================
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.

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Device: Transcranial direct current stimulation (Eldith DC Stimulator)


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham transcranial direct current stimulation<br> | Device: Transcranial direct current stimulation (Eldith DC Stimulator)<br>* Eldith DC Stimulator (NeuroConn GmbH, Germany)<br>|
| Active Comparator: Transcranial direct current stimulation<br> | Device: Transcranial direct current stimulation (Eldith DC Stimulator)<br>* Eldith DC Stimulator (NeuroConn GmbH, Germany)<br>|
| Active Comparator: Different transcranial direct current stimulation montage<br> | Device: Transcranial direct current stimulation (Eldith DC Stimulator)<br>* Eldith DC Stimulator (NeuroConn GmbH, Germany)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |