- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07657234
tDCS for Late-Life Depression
High-Dose Spaced Bilateral tDCS for Late-Life Depression: Open-Label Pilot Study
The purpose of this research study is to determine the effectiveness of Transcranial direct current stimulation (tDCS) therapy in the treatment of participants with Late-life depression (LLD).
The study will evaluate feasibility, safety, and tolerability of high-dose (6mA) bilateral tDCS delivered as three daily sessions, 3 times a week, for 3 weeks in older adults (60 y/o and older) with late-life depression.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Clinical Research Coordinator
- Telefoonnummer: 214-645-2991
- E-mail: alexus.washington@utsouthwestern.edu
Studie Locaties
-
-
Texas
-
Dallas, Texas, Verenigde Staten, 75390
- University of Texas Southwestern Medical Center
-
Hoofdonderzoeker:
- Andre Russowsky Brunoni, MD PhD
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
Participants must meet all of the following criteria:
- age 60 years or older;
- diagnosis of unipolar major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by the Mini International Neuropsychiatric Interview (MINI);
- score of 17 or higher on the 17-item Hamilton Depression Rating Scale (HDRS-17) at screening;
- stable antidepressant regimen for at least four weeks prior to enrollment, if applicable;
- capacity to provide informed consent;
- Clinical Dementia Rating scale of 0 or 0.5.
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
- contraindications to tDCS including metallic cranial implants, skin conditions at electrode sites (eczema, open wounds, burns, lesions), or history of adverse reaction to tDCS;
- contraindications to magnetic resonance imaging (MRI) including pacemaker, cochlear implants, ferromagnetic implants, or claustrophobia;
- history of seizures or epilepsy;
- bipolar disorder, psychotic disorders, or severe personality disorder;
- dementia or MoCA score below 17;
- substance use disorder within the past six months;
- neuromodulation treatment including electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), tDCS, or vagus nerve stimulation (VNS) within the past six months;
- active suicidal ideation with plan or intent requiring a higher level of care;
- concurrent use of medications that substantially lower seizure threshold;
- pregnancy.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: tDCS in older adults with LLD
|
High-intensity (6 mA), spaced (three daily sessions, 3 times a week, for 3 weeks) transcranial direct current stimulation (tDCS) in older adults (60 y/o and over) with Late-Life Depression
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Completion Rate
Tijdsspanne: 6 weeks
|
The proportion of enrolled participants who complete at least 7 of 9 treatment days.
|
6 weeks
|
|
Target dose achievement
Tijdsspanne: 6 weeks
|
The proportion of participants who reach their calculated target dose without dose-limiting intolerance.
|
6 weeks
|
|
Session completion
Tijdsspanne: 6 weeks
|
The proportion of scheduled sessions completed across all participants.
|
6 weeks
|
|
Adverse event profile
Tijdsspanne: 6 weeks
|
Including incidence, severity, and time course of adverse events.
|
6 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Target engagement
Tijdsspanne: 6 weeks
|
Resting-state fMRI measures functional connectivity between the DLPFC and subgenual anterior cingulate cortex (sgACC). The DLPFC-sgACC connectivity is a biomarker of depression that predicts treatment response to neuromodulation. Target engagement would be a significant change in DLPFC-sgACC connectivity. |
6 weeks
|
|
Clinical - HDRS-17
Tijdsspanne: 6 weeks
|
Clinical outcomes are assessed using the HDRS-17 at baseline, weeks 1-5, and week 6.
Response is defined as ≥50% reduction in HDRS-17 from baseline.
Remission is defined as HDRS-17 ≤7.
|
6 weeks
|
|
Correlation of Stimulation Dose With Change in HDRS 17 Scores
Tijdsspanne: 6 weeks
|
Exploratory dose-response analyses will examine correlations between the device stimulation and the changes in clinical outcomes (HDRS-17). This is assessed by correlating achieved baseline E-field (Structural MRI (T1- and T2-weighted) values) and changes in clinical outcomes measured by Hamilton Depression Rating Scale-17 item (HDRS-17). Change in HDRS 17 is defined as the difference between baseline and post-treatment scores at 6 weeks. Correlation analyses (Pearson or Spearman coefficients) are used to quantify the relationship. |
6 weeks
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Andre Russowsky Brunoni, MD PhD, University of Texas Southwestern Medical Center
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- STU20260143
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .