- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02212366
To Enhance Cognition in Late Life Depression Using Transcranial Direct Current Stimulation
Enhancing Cognition in Patients With Late-Life Depression: A Randomized Controlled Trial of Transcranial Direct Current Stimulation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
tDCS is a non-invasive brain stimulation method that utilizes low intensity electrical current either to increase cortical excitability with an anodal electrode or to suppress cortical excitability with a cathodal electrode. tDCS produces its effects through long lasting changes in neuroplasticity: in animal studies, tDCS results in long-term potentiation and brain-derived neurotrophic factor secretion; in human studies, tDCS results in potentiation of neurophysiologic markers of neuroplasticity. Consistent with these preclinical findings, tDCS to the temporoparietal cortex or left DLPFC improves memory in patients with mild to moderate Alzheimer disease(AD). tDCS has also been tested among patients with depression - including by our group - but mainly as a treatment for depressive symptoms. In one recent large study one session of bilateral anodal tDCS was shown to enhance working memory among midlife participants with major depression prior to receiving any treatment. However, it is still not known (1) whether tDCS improves cognition beyond the partial improvement that is associated with resolution of depressive symptoms; or (2) whether it has a more fundamental and long lasting effect on cognition.
This trial will assess the acute and long-term effects of a 2-week course of daily (5 days/week) bilateral anodal tDCS of the DLPFC on cognition, and in particular working memory among 36 patients with LLD. We will recruit and randomize participants who have already been treated for LLD prior to consenting to the study and who still meet criteria for remission while on antidepressant medications.
This trial will also be used as a platform to explore the effect of tDCS on neurophysiologic measures of plasticity during working memory performance. Working memory is supported by re-entrant circuits, some are local within the DLPFC and others are long-range connecting the DLPFC to more posterior cortices. These networks result in high and low frequency neuronal oscillations that can be captured by electroencephalography (EEG). Using novel neurophysiologic analyses, our group and others have demonstrated that the modulation of high-frequency (particularly gamma) oscillations by low-frequency (particularly theta) oscillations - "theta-gamma coupling" - is a neurophysiologic marker of working memory. Thus, we will explore the effect of tDCS on theta-gamma coupling.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M6J1H4
- Center for Addiction and Mental Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women and men of any races or ethnicity
- Age 60 and above
- Major depressive disorder, single or recurrent per SCID DSM-IV criteria AND remission from that episode as defined by DSM IV-TR criteria for remission.
- Montgomery-Asberg Depression Rating Scale (MADRS) score less than 10.
- Ability to speak English fluently enough to complete all research assessments.
- Corrected visual ability to read newspaper headlines; hearing capacity to respond to a raised conversational voice
- Willingness and ability to provide consent
Exclusion Criteria:
- DSM IV TR criteria for any dementia
- DSM IV TR criteria for life-time bipolar disorder, schizophrenia, schizoaffective disorder, or other psychotic disorders
- DSM IV TR criteria for any substance abuse or dependence within the past 6 months
- Presence of psychotic features or any other symptoms that would make the participant unable to participate in the study.
- Any medical contra-indications to tDCS.
- Electroconvulsive therapy in the last 6 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active TDCS
2-week course of daily (5 days/week) active bilateral anodal TDCS, duration 30 minute each session.
Current 2 mA.
|
Active Stimulation
|
Sham Comparator: Sham TDCS
2-week course of daily (5 days/week) Sham bilateral tDCS.
Duration 30 minute each session.
|
Sham Stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare performance on working memory task (N-Back) and neuropsychological battery between active and sham TDCS groups
Time Frame: Two weeks following the TDCS course
|
Two weeks following the TDCS course
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare performance on working memory task (N-Back) and neuropsychological battery between active and sham TDCS groups
Time Frame: Three months following the TDCS course
|
Three months following the TDCS course
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare theta-gamma coupling as measured by electroencephalography between active and sham TDCS groups.
Time Frame: Two weeks following the TDCS
|
Two weeks following the TDCS
|
To compare theta-gamma coupling as measured by electroencephalography between active and sham TDCS groups.
Time Frame: 3 months following the TDCS
|
3 months following the TDCS
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Tarek K Rajji, MD, Center for Addiction and Mental Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 131/2013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
Clinical Trials on Active TDCS
-
Bambino Gesù Hospital and Research InstituteCompleted
-
The University of Texas at DallasActive, not recruiting
-
University of California, Los AngelesNational Institute of Mental Health (NIMH)Completed
-
The University of Texas at DallasCompleted
-
Gaziler Physical Medicine and Rehabilitation Education...Active, not recruitingChronic StrokeTurkey
-
University of LiegeCompletedDisorders of ConsciousnessBelgium
-
University of Sao Paulo General HospitalFundação Faculdade de MedicinaCompleted
-
Ankara City Hospital BilkentActive, not recruitingChronic Spinal Cord DisorderTurkey
-
Spaulding Rehabilitation HospitalCompletedPelvic Pain | Pancreatitis | Visceral PainUnited States
-
The University of Texas Health Science Center,...Milken InstituteRecruiting