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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
Sponsor:
Information provided by (Responsible Party):
Salih Selek, The University of Texas Health Science Center, Houston

Brief Summary:
The purpose of this study is to determine the effectiveness of MST in bipolar depression and to compare the side effects of magnetic seizure therapy (MST) and electroconvulsive therapy (ECT)

Condition or disease Intervention/treatment Phase
Bipolar Disorder Device: MST Device: ECT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arm Intervention/treatment
Experimental: MST Device: 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.

Active Comparator: ECT Device: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are diagnosed by Bipolar I or II, current episode depressed who require a rapid response due to the severity of their psychiatric or medical condition
  • Patients of any race and ethnic group
  • Ability to provide informed consent or assent
  • Ability to adhere to the study procedures
  • For females of reproductive potential:use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional one week after the end of ECT/transcranial magnetic stimulation (TMS) administration. Of note, ECT is indicated in depression during pregnancy and has been safely used for decades but MST's effects on fetus are still unknown
  • For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
  • Has sufficient English in completing self-rated scales
  • Good general health evidenced by obtained medical clearance before the procedures from another provider
  • On a stable drug regimen of psychotropic medication for at least 6 weeks at the time of entry into the study. Medication changes can be made during patient's study participation but would be limited to the clinical judgment of the PI

Exclusion Criteria:

  • 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 simulators (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).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 anaesthesia contraindications including significant cardiac or other medical risk factors.
  • Body Mass Index over 60, as the investigator's 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,example,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
  • Known allergic reactions to components of anaesthetic or induction agents including succinylcholine, methohexital, 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Salih Selek, MD (713) 741-3936 Salih.Selek@uth.tmc.edu
Contact: Ana Ruiz (713) 741-3951 Ana.C.Ruiz@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Salih Selek, MD    713-741-3936    Salih.Selek@uth.tmc.edu   
Contact: Ana Ruiz    (713) 741-3951    Ana.C.Ruiz@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Salih Selek, MD The University of Texas Health Science Center, Houston
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Responsible Party: Salih Selek, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04080778    
Other Study ID Numbers: HSC-MS-19-0468
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Seizures
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases