Who is eligible for clinical trial NCT04080778?

Participants must meet the protocol's inclusion criteria for Bipolar Disorder. The stated age range is 22 Years to 85 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT04080778 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

Magnetic Seizure Therapy in Bipolar Depression (MST-BpD) and Treatment Resistant Depression (MST-TRD) (NCT04080778)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Joao L. DeQuevedo

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this study is to compare the efficacy and side effects magnetic seizure therapy (MST) and electroconvulsive therapy (ECT) in Bipolar Depression (MST-BpD) and Treatment Resistant Depression (MST-TRD).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (5 items).

Location: The University of Texas Health Science Center at Houston — Houston, Texas

Age range: 22 Years to 85 Years

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).

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Condition or diagnosis that precludes participation, including: Patients who have an implanted device that is activated or controlled in any way by physiological signals (examples: pacemakers, implantable cardioverter defibrillators \[ICD's\], vagus nerve stimulators \[VNS\] and wearable cardioverter-defibrillators \[WCD's\],ocular implants, deep brain stimulators, implanted medication pumps, intracardiac lines, even when removed; Patients who have conductive, ferromagnetic or other magnetic sensitive metals implanted in their head or within 30 cm of the treatment coil such as stents and bullet fragments). NOTE: Standard amalgam dental fillings are not affected by the magnetic field and are acceptable in patients\]; Patients suffering from vascular, traumatic, infectious, or metabolic lesions of the brain, even without a history of seizure, or without anticonvulsant medication; Patient suffering from sleep deprivation or alcoholism; Current or unstably remitted substance use disorder except nicotine or caffeine use disorder. Stable remission is defined as remission for at least 6 months; Pregnant or nursing patients; Patients with a history of epilepsy or unexplained seizures; Subjects with a history of space-occupying intracranial pathology; diseases which render a patient likely to suffer hemorrhage, including subdural hematoma, and aortic aneurysm; degenerative diseases of the central nervous system such as dementia or medical illness affecting brain function; Any anesthesia contraindications including significant cardiac or other medical risk factors; Body Mass Index over 60, as our ECT suite stretchers are not equipped to handle overweight patients; History of severe personality disorder, where, based on the judgment of the investigators, the personality disorder will interfere with the patient's ability to complete the follow-up protocol, e.g. borderline personality disorder; Imminent risk of suicide (based on the judgment of the investigators; e.g. patient has a plan for suicide, patient is not likely to seek medical attention in case of suicide, patient exhibits the presence of current suicidal ideation; Not able to comply with the operational and administrative requirements of participation in the study (based on the judgment of the investigators); Terminal illness associated with expected survival of \<12 months; Bipolar Depression with psychotic features (ICD-10 code:F31.5)
Known allergic reactions to components of anaesthetic or induction agents including succinylcholine, metohexitol, ketamine, propofol, ketorolac.
Participation in another drug, device, or biologics trial within the preceding 30 days
Disallowed concomitant medications: antiepileptics and benzodiazepines as they are against seizure therapies, short or mid acting benzodiazepines such as alprazolam, temazepam, midazolam, lorazepam will be allowed but they should be skipped at least 10 hours before the procedures. Medications that are supposed to have weak antiepileptic features such as lamotrigine, topiramate, gabapentin will be reviewed by the PI and either tapered down or discontinued based upon clinical judgment. Lithium will be tapered off before the procedure because of the increased risk of postictal disorientation and delirium.

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

📍 All Participating Trial Locations (1 Sites)

The University of Texas Health Science Center at Houston — Houston, Texas

📞 Contact the Study Coordinator

Phone: (713) 486-2705

Email: Joao.L.DeQuevedo@uth.tmc.edu

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.

💡 How to Participate

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

🏛️ View Official NIH Record ↗