tDCS for Late-Life Depression
ConditionLate Life Depression (LLD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorAndre Russowsky Brunoni
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
High-intensity (6 mA) transcranial direct current stimulation (tDCS)
DeviceHigh-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
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: tDCS in older adults with LLDExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Completion Rate
The proportion of enrolled participants who complete at least 7 of 9 treatment days.
Time frame
6 weeks2
Target dose achievement
The proportion of participants who reach their calculated target dose without dose-limiting intolerance.
Time frame
6 weeks3
Session completion
The proportion of scheduled sessions completed across all participants.
Time frame
6 weeks4
Adverse event profile
Including incidence, severity, and time course of adverse events.
Time frame
6 weeksSecondary outcomes
1
Target engagement
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 weeks2
Clinical - HDRS-17
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 weeks3
Correlation of Stimulation Dose With Change in HDRS 17 Scores
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.
Time frame
6 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Andre Russowsky Brunoni
Lead sponsor
University of Texas Southwestern Medical Center
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: