University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Location status: Recruiting
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.
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Phase 1 / Phase 2
Dallas, Texas, 75390, United States
Location status: Recruiting
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 participants who tolerate 6mA across the entire treatment course without dose-limiting adverse events.
Time frame: 6 weeks
Completion Rate: The proportion of enrolled participants who complete 21 of 27 treatments over a 3-week period.
Time frame: 6 weeks
Clinical outcomes are assessed using the Inventory of Depressive Symptomatology, Clinician Version (IDS-C) at baseline and week 6.
Mean change in IDS-C score across participants.
Time frame: 6 weeks
Response is defined as ≥50% reduction in IDS-C from baseline. Proportion of responders at week 6.
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.
Interested in participating?
Request InfoAndre Russowsky Brunoni
Other
High-Dose Spaced Bilateral tDCS for Late-Life Depression: Open-Label Pilot Study
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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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