- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Ontario
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Toronto, Ontario, Kanada, M6J1H4
- Center for Addiction and Mental Health
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Active TDCS
2-week course of daily (5 days/week) active bilateral anodal TDCS, duration 30 minute each session.
Current 2 mA.
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Active Stimulation
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Schein-Komparator: Sham TDCS
2-week course of daily (5 days/week) Sham bilateral tDCS.
Duration 30 minute each session.
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Sham Stimulation
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
To compare performance on working memory task (N-Back) and neuropsychological battery between active and sham TDCS groups
Zeitfenster: Two weeks following the TDCS course
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Two weeks following the TDCS course
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
To compare performance on working memory task (N-Back) and neuropsychological battery between active and sham TDCS groups
Zeitfenster: Three months following the TDCS course
|
Three months following the TDCS course
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
To compare theta-gamma coupling as measured by electroencephalography between active and sham TDCS groups.
Zeitfenster: 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.
Zeitfenster: 3 months following the TDCS
|
3 months following the TDCS
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Tarek K Rajji, MD, Center for Addiction and Mental Health
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 131/2013
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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