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
Qualifiers
≥ 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
Treatments tested in this trial
- Closed-loop tACS
- Sham Comparator
Treatment groups
214 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov