Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorPulvinar Neuro, LLC
About this trial
The purpose of this research study is to investigate a closed-loop transcranial alternating current stimulation (tACS) device to evaluate its ability to reduce symptoms of major depressive disorder
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 22 years of age;
with at least moderate symptom severity (HAM-D17 ≥ 17);
who are currently in a depressive episode;
who have used at least 1 antidepressant in the current or previous episode, but have not found adequate symptom relief or who were not able to tolerate medication side effects;
Disqualifiers
Subjects with current / past six months use of an external stimulation device for MDD, including electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), or other brain or cranial nerve stimulation;
Subjects with (lifetime) history of failure to response to an adequate trial of ECT, TMS, or implanted vagus nerve stimulation;
Subjects who currently receive esketamine, ketamine, or psilocybin treatment
Subjects who are pregnant or of childbearing potential and not using adequate contraception, as determined by the investigator;
Trial design
Design model
Parallel
Treatments tested in this trial
Closed-loop tACS
DeviceIndividual alpha tACS
Sham Comparator
DeviceSham stimulation
Treatment groups
214 Participants
are divided into 3 treatment groupsGroup A: Active Closed-loop tACSExperimental treatment 1 intervention
Group B: Sham Closed-loop tACSSham comparator 1 intervention
Group C: Open Label, Active Closed-loop tACS RetreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Hamilton Depression Rating Scale (HDRS) score reduction, Phase 1 Evaluation
Response rates (at least 50% reduction in HDRS-D17 score) (0-52 score range, higher score is worse)
Time frame
Timeframe: Baseline to Week 3Secondary outcomes
1
Hamilton Depression Rating Scale (HDRS) Score reduction, at study end
Response rates (at least 50% reduction in HDRS-17 score) for patients at their study completion. This will be evaluated by determining the percentage of patients from the active stimulation arm who can be classified as responders either at the phase 1, week 3 assessment OR at the phase 2, week 3 assessment. (0-52 score range, higher score is worse)
Time frame
At the phase 1, week 3 assessment OR at the phase 2, week 3 assessment.2
The State-Trait Anxiety Inventory (STAI) Score
Change in self-reported anxiety symptoms STAI Trait (score range is 20-80, higher is worse)
Time frame
Timeframe: Baseline to week 3, Phase 13
Hamilton Depression Rating Scale (HDRS) Remission Rate
Remission rates (HDRS-17 score ≤ 7) (0-52 score range, higher score is worse)
Time frame
Timeframe: Baseline to Week 3, Phase 14
Hamilton Depression Rating Scale (HDRS) Remission Rate at Baseline Evaluation
Remission rates (HDRS-17 score ≤ 7) (0-52 score range, higher score is worse)
Time frame
Timeframe: Baseline to Day 5Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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