The purpose of this research study is to study a closed-loop transcranial alternating current stimulation (tACS) device to evaluate feasibility of the product in a clinical trial and collect preliminary data on potential effects on symptoms of depression in people with major depressive disorder.
The purpose of this study is to investigate device feasibility and performance of the XCSITE 100 Pro V2 device and assess preliminary efficacy of closed-loop transcranial alternating current stimulation (CL-tACS) for reducing symptoms of major depressive disorder (MDD) in a double-blind, sham-controlled, parallel group, single-site clinical trial. A total of 40 participants will be randomized to receive active or sham CL-tACS via carbon-silicone electrodes for up to 40 minutes over 5 consecutive days. Device feasibility and performance data will be collected from every stimulation session. Clinical assessments of depression and related symptoms will be performed at Baseline (Day 1), End Of Treatment (EOT; Day 5), and Follow-Up (FUP, 2-weeks post-treatment, Day 19). High-density electroencephalography (HD-EEG) will be performed at Baseline, EOT and FUP. An optional MRI will be performed up to 30 days before, or on Baseline, to provide anatomical data for EEG brain connectivity analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
TRIPLE
Enrollment
40
Individual alpha tACS
Sham stimulation
Carolina Center for Neurostimulation
Chapel Hill, North Carolina, United States
Correct Assignment by Device of Study Arm
Successful assignment by device software to correct study arm for each participant for each session, Day 1 (D1) through Day 5 (D5). Measured as percentage of successful assignments compared to intended programming.
Time frame: 5 days
Accuracy of Device Study Arm Parameters by Device
Verification of correct study arm parameters applied by device for each participant for each session, Day 1 (D1) through Day 5 (D5).
Time frame: 5 days
Accuracy of Stimulation Initiation Based on EEG by Device
Verification of correct stimulation initiation decisions for each evaluated EEG window by device for each participant for each session, Day 1 (D1) through Day 5 (D5).
Time frame: 5 days
Accuracy of Device Logs Uploaded to Cloud by Device
Verification of equivalence between logs stored on local device and corresponding logs uploaded to cloud for each participant for each session, Day 1 (D1) through Day 5 (D5).
Time frame: 5 days
HDRS-17 Change
Change in HDRS-17 from two week follow-up (FUP) to D1 between Experimental and Sham Comparator study arms; minimum value is 0, maximum value is 52. Higher scores indicate worse outcome.
Time frame: 21 Days
Change in Alpha Oscillation Power
Change in EEG alpha oscillation power between D1 and D5 between Experimental and Sham Comparator study arms.
Time frame: 5 Days
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