RecruitingNot ApplicableNCT04080778

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


Sponsor

Joao L. DeQuevedo

Enrollment

60 participants

Start Date

Aug 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 22 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing magnetic seizure therapy (MST) — a newer, more targeted alternative to electroconvulsive therapy (ECT) — in people with bipolar depression or treatment-resistant depression. MST uses a powerful magnetic field to induce a controlled seizure in the brain. Researchers believe it may be as effective as ECT but with fewer memory side effects. **You may be eligible if...** - You have been diagnosed with Bipolar I or II disorder, currently in a depressive episode, OR you have treatment-resistant depression (depression that has not responded to multiple treatments) - A rapid response to treatment is needed due to the severity of your condition - You meet the ICD-10 diagnostic criteria for your condition **You may NOT be eligible if...** - You have medical conditions that make the procedure unsafe (such as metal implants in the head, certain heart conditions, or risk of seizure complications) - You are not a candidate for this type of brain stimulation therapy - Your doctor determines the treatment is not appropriate for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEmagnetic seizure therapy (MST)

MST will be performed with the MagPro XP (120 V) device under anesthesia 2-3 times a week up to 15 sessions.Treatment is performed by magnetic stimulation of both hemispheres inducing a focal stimulation above vertex, using a serial of pulse trains with a frequency of at least 25 Hz but up to 100 Hz for 4-6 s (up to 10 s), which is sufficient to induce a tonic clonic seizure.

DEVICEelectroconvulsive therapy (ECT)

ECT will be performed with MECTA 5000Q, 4th generation ECT devices provided by MECTA Corporation under anesthesia 2-3 times a week up to 15 sessions. For initial procedure Seizure Threshold (ST) will be estimated by empiric titration in the first session of each participant. ST will be then determined as by the manufacturer of ECT Device by the titration schedule for the initial titration session. The subsequent treatment sessions were dosed at 6 times the charge of the seizure threshold.


Locations(1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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NCT04080778


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