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

NCT01339598 | Completed Phase 1 DMC

• 1 other identifier: HREC 11065
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

Sham transcranial direct current stimulation

SHAM COMPARATOR

Device: Transcranial direct current stimulation (Eldith DC Stimulator)

Transcranial direct current stimulation

ACTIVE COMPARATOR

Device: Transcranial direct current stimulation (Eldith DC Stimulator)

Different transcranial direct current stimulation montage

ACTIVE COMPARATOR

Device: Transcranial direct current stimulation (Eldith DC Stimulator)

Interventions

Transcranial direct current stimulation (Eldith DC Stimulator) DEVICE

Eldith DC Stimulator (NeuroConn GmbH, Germany)

Different transcranial direct current stimulation montage; Sham transcranial direct current stimulation; Transcranial direct current stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The University of New South Wales: lead

Study Sites (1)

University of New South Wales

Sydney, New South Wales, 2031, Australia

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 20, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: October 1, 2015
• Last Updated: November 3, 2015

Record last verified: 2015-07

Locations

AU (1)