University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Location contact
Andre Russowsky Brunoni, MD PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07657234
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.
Trial opening soon.
Get Notified60 year and older
All sexes
Interventional
Not applicable
Dallas, Texas, 75390, United States
Andre Russowsky Brunoni, MD PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants must meet all of the following criteria:
Exclusion criteria
Participants meeting any of the following criteria will be excluded:
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
Time frame: 6 weeks
The proportion of enrolled participants who complete at least 7 of 9 treatment days.
Time frame: 6 weeks
The proportion of participants who reach their calculated target dose without dose-limiting intolerance.
Time frame: 6 weeks
The proportion of scheduled sessions completed across all participants.
Time frame: 6 weeks
Including incidence, severity, and time course of adverse events.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Andre Russowsky Brunoni
Other
High-Dose Spaced Bilateral tDCS for Late-Life Depression: Open-Label Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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