Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder (NCT07282678)

🧪 Interventions in This Study

• Closed-loop tACS (DEVICE)
• Sham Comparator (DEVICE)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. ≥ 22 years of age;
2. with at least moderate symptom severity (HAM-D17 ≥ 17);
3. who are currently in a depressive episode;
4. 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;
5. who, for 6 weeks prior to enrollment, are either;
6. not taking antidepressant medication, or:
7. are taking a stable psychiatric medication regimen with one or more stable antidepressant medication dose(s) and agree to continue the same regimen throughout study participation
8. if currently engaged in depression-focused psychotherapy, have maintained stable frequency of therapy for at least 8 weeks prior to enrollment and agree to continue the same regimen throughout study participation;
9. are able and willing to comply with the protocol and follow up schedule and protocol, in the opinion of the investigator;
10. who understand English and are able to provide written informed consent;
11. who are currently under the care of a psychiatric clinician or a primary care physician for major depressive disorder, and who agree to promptly inform the study staff of any change of psychiatric or mental health providers during study participation;
12. who agree to allow any and all forms of communication between the investigators/study staff and their current or past (within 2 years) healthcare providers;

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• Qortical Clinical Partners — Durham, North Carolina

📞 Contact the Study Coordinator

Phone: (910) 447-6576

Email: chris.walker@pulvinarneuro.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.