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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Clinical Research Coordinator
- Phone Number: 214-645-2991
- Email: alexus.washington@utsouthwestern.edu
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390
- Recruiting
- University of Texas Southwestern Medical Center
-
Principal Investigator:
- Andre Russowsky Brunoni, MD PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Structured Clinical Interview for DSM-5 (SCID-5);
- score of 16 or higher on the Quick Inventory of Depressive Symptomology-Clinician Rated (QIDS-C) at screening;
- stable antidepressant regimen for at least four weeks prior to enrollment, if applicable;
- willingness and capacity to provide informed consent;
- Clinical Dementia Rating scale of 0 or 0.5.
- availability of an informant who has sufficient knowledge of the participant's daily functioning as ascertained by the study team.
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;
- depressive disorder due to a medical condition;
- psychotic depression;
- history of seizures or epilepsy;
- bipolar disorder;
- psychotic disorders;
- severe personality disorder;
- active substance use disorder within the past six months or history of substance induced mood or psychotic disorder;
- 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;
- a clinically established diagnosis of dementia as reported in the participant's health record or scoring 1 or above on CDR;
- medically unstable in the clinical opinion of the principal investigators.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment Tolerability
Time Frame: 6 weeks
|
The proportion of participants who tolerate 6mA across the entire treatment course without dose-limiting adverse events. |
6 weeks
|
|
Treatment Feasibility
Time Frame: 6 weeks
|
Completion Rate: The proportion of enrolled participants who complete 21 of 27 treatments over a 3-week period. |
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean change in IDS-C score
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. |
6 weeks
|
|
Depression Response Rate
Time Frame: 6 weeks
|
Response is defined as ≥50% reduction in IDS-C from baseline. Proportion of responders at week 6. |
6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Target engagement
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. |
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andre Russowsky Brunoni, MD PhD, University of Texas Southwestern Medical Center
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU20260143
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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