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To Enhance Cognition in Late Life Depression Using Transcranial Direct Current Stimulation

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ClinicalTrials.gov Identifier: NCT02212366
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : January 24, 2018
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Tarek Rajji, Centre for Addiction and Mental Health

Brief Summary:
Late Life Depression (LLD) is a serious health problem which not only causes depressed mood but also results in impairments in memory and attention. These impairments are likely to be resistant to treatment, which increases the chances of developing dementia even after successful treatment of mood.This study is a randomized controlled trial of transcranial Direct Current Stimulation (tDCS) in people with LLD to enhance their cognition after successful treatment of mood with established medications. tDCS is non invasive, relatively inexpensive and portable, and has been found to be safe.This study also serves as a pilot study to assess the effects of tDCS on cognition and neurophysiologic markers of cognition among patients with LLD. Primary study hypothesis is that participants Participants randomized to tDCS will perform better on a working memory task 2 weeks and 3 months following the tDCS course.

Condition or disease Intervention/treatment Phase
Cognition Depression Device: Active TDCS Device: Sham TDCS Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Cognition in Patients With Late-Life Depression: A Randomized Controlled Trial of Transcranial Direct Current Stimulation
Study Start Date : May 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

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.
Device: Active TDCS
Active Stimulation

Sham Comparator: Sham TDCS
2-week course of daily (5 days/week) Sham bilateral tDCS. Duration 30 minute each session.
Device: Sham TDCS
Sham Stimulation




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. To compare theta-gamma coupling as measured by electroencephalography between active and sham TDCS groups. [ Time Frame: Two weeks following the TDCS ]
  2. To compare theta-gamma coupling as measured by electroencephalography between active and sham TDCS groups. [ Time Frame: 3 months following the TDCS ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women and men of any races or ethnicity
  2. Age 60 and above
  3. 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.
  4. Montgomery-Asberg Depression Rating Scale (MADRS) score less than 10.
  5. Ability to speak English fluently enough to complete all research assessments.
  6. Corrected visual ability to read newspaper headlines; hearing capacity to respond to a raised conversational voice
  7. Willingness and ability to provide consent

Exclusion Criteria:

  1. DSM IV TR criteria for any dementia
  2. DSM IV TR criteria for life-time bipolar disorder, schizophrenia, schizoaffective disorder, or other psychotic disorders
  3. DSM IV TR criteria for any substance abuse or dependence within the past 6 months
  4. Presence of psychotic features or any other symptoms that would make the participant unable to participate in the study.
  5. Any medical contra-indications to tDCS.
  6. Electroconvulsive therapy in the last 6 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212366


Locations
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Canada, Ontario
Center for Addiction and Mental Health
Toronto, Ontario, Canada, M6J1H4
Sponsors and Collaborators
Centre for Addiction and Mental Health
Ontario Ministry of Health and Long Term Care
Investigators
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Principal Investigator: Tarek K Rajji, MD Center for Addiction and Mental Health

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Responsible Party: Tarek Rajji, Principal Investigator, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT02212366     History of Changes
Other Study ID Numbers: 131/2013
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tarek Rajji, Centre for Addiction and Mental Health:
TDCS
Depression
Brain Stimulation
Memory
Cognition
EEG
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders