Magnetic Seizure Therapy In Bipolar Depression (MST-BpD)
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|ClinicalTrials.gov Identifier: NCT04080778|
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : May 17, 2022
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Device: MST Device: ECT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Magnetic Seizure Therapy In Bipolar Depression (MST-BpD)|
|Estimated Study Start Date :||October 1, 2022|
|Estimated Primary Completion Date :||October 30, 2024|
|Estimated Study Completion Date :||October 30, 2024|
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.
|Active Comparator: 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.
- Number of participants who go into remission [ Time Frame: From baseline to week 6 ]Remission is defined as a score of 4 or below as assessed by The Severity Measure for Depression-Adult measure (adapted from the Patient Health Questionnaire-9 [PHQ-9]). The Severity Measure for Depression-Adult measure is a 9-item scale, and each item on the measure is rated on a 4-point scale. The total score ranges from 0 to 27, with higher scores indicating greater severity of depression.
- Change in cognitive impairment as measured by the Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline,week 6 ]Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04080778
|Contact: Salih Selek, MD||(713) 741-3936||Salih.Selek@uth.tmc.edu|
|Contact: Ana Ruiz||(713) 741-3951||Ana.C.Ruiz@uth.tmc.edu|
|Principal Investigator:||Salih Selek, MD||The University of Texas Health Science Center, Houston|