Magnetic Seizure Therapy for Schizophrenia - Trial

NCT ID: NCT06672588

Last Updated: 2026-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-22

Study Completion Date

2028-11-30

Brief Summary

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This trial aims to assess the clinical effects and tolerability of Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for Treatment Resistant Schizophrenia (RS).

Detailed Description

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The study will involve a randomized, double blind, non-inferiority clinical trial with two treatment arms conducted in two academic institutions (the Centre for Addiction and Mental Health (CAMH) in Toronto, and University of British Columbia (UBC) Hospital in Vancouver, British Columbia). The investigators will compare MST to right unilateral ultrabrief pulse ECT (RUL-UB-ECT). Treatment will be administered two to three days per week. Clinical response will be assessed with the 18-item Brief Psychiatric Rating Scale (BPRS). Response will be defined as greater than or equal to 40% decrease in the BPRS positive psychotic symptom subscale (4 items - hallucinatory, behavior, suspiciousness, conceptual disorganization, and unusual thought content). Patients who do not meet response criteria after 15 treatment sessions will be considered non-responders and will cease treatment sessions. The blind will not be broken to participants until the completion of the entire study.

Conditions

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Treatment Resistant Schizophrenia Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is a randomized, double blind, parallel-group clinical trial with two treatment arms conducted at two academic institutions. The aim is to recruit 80 participants in the hope of having 50 participants complete the study.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Participants will be randomized into the study using a permuted block method with a random number generator. The study statistician will prepare the randomization scheme. The block size will be fixed and study personnel will be blinded to the randomization block size.

Study Groups

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Electroconvulsive Therapy (ECT)

ECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma.

Group Type ACTIVE_COMPARATOR

Electroconvulsive Therapy (ECT)

Intervention Type DEVICE

In the ECT arm treatment, the MECTA spectrum 5000Q or MECTA sigma machine will be used. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold. Patients will receive care and be managed by anaesthesia as per standard ECT practice.

Magnetic Seizure Therapy (MST)

MST treatments will be administered using the MagPro MST with Cool TwinCoil.

Group Type EXPERIMENTAL

Magnetic Seizure Therapy (MST)

Intervention Type DEVICE

MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation at 100% machine output. Seizure threshold will follow prior protocols used for frontal MST. Patients will receive care and be managed by anaesthesia as per standard ECT practice.

Interventions

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Magnetic Seizure Therapy (MST)

MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation at 100% machine output. Seizure threshold will follow prior protocols used for frontal MST. Patients will receive care and be managed by anaesthesia as per standard ECT practice.

Intervention Type DEVICE

Electroconvulsive Therapy (ECT)

In the ECT arm treatment, the MECTA spectrum 5000Q or MECTA sigma machine will be used. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold. Patients will receive care and be managed by anaesthesia as per standard ECT practice.

Intervention Type DEVICE

Other Intervention Names

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MST ECT

Eligibility Criteria

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Inclusion Criteria

1. are inpatients or outpatients;
2. demonstrate capacity to consent according to the MacArthur competence assessment tool for clinical research (MacCAT-CR);
3. have a DSM-5 diagnosis of Schizophrenia or Schizoaffective Disorder for at least 2 years, as determined by the MINI International Neuropsychiatric Interview - Version 7 (MINI-7.0);
4. are 18 years of age or older;
5. have demonstrated resistance to at least 2 antipsychotics of 600 mg of chlorpromazine equivalents for at least 6 weeks;
6. have a BPRS score at baseline of at least moderate severity (\>4) on one of the four psychotic items (i.e., hallucinatory behavior, suspiciousness, conceptual disorganization, unusual thought content) or at least 12 on these 4 items combined;
7. are considered to be appropriate to receive convulsive therapy as assessed by an ECT attending psychiatrist and a consultant anaesthesiologist;
8. are on an antipsychotic at an adequate dose and are agreeable to keeping their current antipsychotic treatment constant during the acute phase of the intervention;
9. are able to adhere to the intervention schedule;
10. meet the MST safety criteria;
11. If a woman of child-bearing potential: is willing to provide a negative pregnancy test and agrees not to become pregnant during trial participation.

Exclusion Criteria

1. have a history of MINI diagnosis of a substance use disorder (other than nicotine and caffeine) within the past three months;
2. have a concomitant major unstable medical illness;
3. are pregnant or intend to get pregnant during the study;
4. have probable dementia based on study investigator assessment;
5. have any significant neurological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm;
6. present with a serious medical condition,
7. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
8. require a benzodiazepine with a dose \> lorazepam 2 mg/day or equivalent or any anticonvulsant due to the potential of these medications to limit the efficacy of both MST and ECT;
9. are unable to communicate in English fluently enough to complete the neuropsychological tests;
10. have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Blumberger, M.D., MSc.

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

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University of British Columbia Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Daniel Blumberger, MD., MSc.

Role: CONTACT

416-535-8501 ext. 33662

Hannah Taalman, MSc.

Role: CONTACT

416-535-8501 ext. 30990

Facility Contacts

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Anabelle McPherson

Role: primary

604-827-1361

Hanna Abraham

Role: primary

416-535-8501 ext. 30772

Hannah Taalman, MSc.

Role: backup

416-535-8501 ext. 30990

Related Links

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https://www.camh.ca/en/science-and-research

Information About Research At the Centre for Addiction and Mental Health

Other Identifiers

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2105

Identifier Type: -

Identifier Source: org_study_id

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