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CompletedNCT03361826Updated Feb 13, 2025

Magnetic Seizure Therapy for the Treatment of Borderline Personality Disorder

An interventional study of MagPro MST with Cool TwinCoil and DBT in Borderline Personality Disorder, sponsored by Centre for Addiction and Mental Health. Completed at 1 site in Canada. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-02-13.

Sponsored by Centre for Addiction and Mental Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 24 studies in Borderline Personality Disorder with a site in Canada — 7 open to participants now, 8 under way, none of them phase 3. Borderline Personality Disorder · Canada.

Enrollment
19th of 23
27 · median 60
Started
2017
the only one that year
No phase
19 of 24
4 open now
Registered
9th of 24
by date
Lead sponsor
6 of 24
Centre for Addiction and Mental Health

Among the 24 studies in Borderline Personality Disorder with a site in Canada, this one is the 19th largest by enrollment of the 23 interventional ones that give a count, is the only one that started in 2017, is one of 19 with no phase, and was the 9th registered.

Borderline Personality Disorder

278 studies on the registry are indexed under Borderline Personality Disorder; 70 are open to participants now.

Browse Borderline Personality Disorder studies →

Open to participants now

7 of the 24 studies in Borderline Personality Disorder with a site in Canada are open now. Recruiting first, the newest first:

2 more — sign in →

All 7 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 49 Borderline Personality Disorder studies recruiting now, 18 (37%) set no upper age limit and 30 (61%) stop at 75 or younger; 8 take children under 18; 11 take healthy volunteers.

This study: 18 Years to 50 Years · female · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 24 studies in Borderline Personality Disorder with a site in Canada, or all of them as a file.
02

Study summary

Suicide is a major public health crisis for which effective new interventions are needed. An innovative new brain stimulation technique called magnetic seizure therapy (MST) shows promise for treating suicidal thinking in chronically depressed individuals. Using a high-risk cohort of suicidal patients with borderline personality disorder (BPD) and treatment resistant major depressive disorder (MDD), this study will evaluate the effectiveness of MST for reducing suicidality and depressive symptoms in an open-label clinical trial of up to 15 treatment sessions. Based on research showing that functioning of the dorsolateral prefrontal cortex (DLPFC) may be disrupted in BPD and place individuals at risk for suicide, the DLPFC will be targeted for stimulation. Moderate-to-highly suicidal patients with BPD beginning dialectical behavioural therapy (DBT) will be recruited using a case-control design, comparing individuals receiving MST and DBT with matched patient control group receiving DBT alone.

Read the detailed description

MST is a novel modification of electroconvulsive therapy (ECT) with the potential for similar clinical effectiveness, fewer side-effects and a more rapid return of orientation and shorter duration of post-ictal confusion. In the proposed study, the investigators will evaluate the clinical effectiveness of MST for the treatment of treatment-resistant depression (TRD) and suicidal ideation in patients with BPD. The study will use a case-control design comparing symptom reports (depression severity and suicidal ideation) and cognitive functioning between outpatients receiving MST plus dialectical behavioral therapy (DBT) and matched patient controls receiving DBT alone. To evaluate potential biomarkers that may underlie the anticipated clinical benefits of MST, functional magnetic resonance imaging (fMRI) will be used to measure activation of the DLPFC and associated neural circuits subserving emotion regulation and cognitive functioning (e.g., impulse control, episodic memory) in BPD.

Objective 1: To evaluate the efficacy of MST as a treatment for suicidal ideation and TRD in BPD.

Hypothesis 1: MST will demonstrate substantial efficacy on objective measures of suicidal ideation and depression.

Objective 2: To evaluate the effects of MST on cognitive functioning in patients with BPD.

Hypothesis 2: MST will have limited, if any, effects on performance on standard neuropsychological measures of attention, memory and executive functioning in patients with BPD.

Objective 3: To explore potential neuroimaging-based biomarkers that may index any changes in suicidal ideation and depression that result from treatment with MST.

Hypothesis 3: On neuroimaging tasks assessing emotion processing and cognitive functioning, patients receiving DBT+MST will show increased activity in bilateral DLPFC after treatment relative to pre-treatment baseline activation, and more activation in this region than patients in DBT without concurrent MST (DBT-only).

03

Conditions studied

  • Borderline Personality Disorder

Keywords

  • Magnetic seizure therapy (MST)
  • Treatment resistance
  • Open-label trial
  • Borderline Personality Disorder
  • Suicidal Ideation
  • Treatment-resistant depression
  • Dialectical behavior therapy (DBT)
  • MST + DBT
  • Neuroimaging-based biomarkers
04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • MST+DBT Group

    1. English-speaking and able to provide to participate in the study
    2. Female and between the ages 18 and 50 years
    3. Current (Diagnostic and statistical manual of mental disorders-IV) diagnosis of BPD based on the International Personality Disorder Examination BPD Section (IPDE-BPD)
    4. Current DSM-IV diagnosis of a non-psychotic, major depressive episode, as part of a broader diagnosis of MDD (single episode or recurrent episode), based on the Structured Clinical Interview for DSM-IV Axis I Disorders-Patient Edition (SCID-I/P)
    5. Score > 9 (equivalent to moderate-to-severe suicidal ideation) on the Modified Suicidal ideation Scale for at least the two weeks prior to enrolling in the study
    6. Hamilton Rating Scale for Depression (HRSD-24) score > 22 (classified as Very Severe Depression)
    7. Failed to achieve a clinical response to adequate treatment trials of two or more antidepressants during the current depressive episode OR have been unable to tolerate at least two antidepressants as assessed by the Antidepressant Treatment History Form (ATHF)
    8. Deemed appropriate to receive ECT as assessed by an ECT attending psychiatrist and an anesthesiologist
    9. Meets the MST safety criteria
    10. Agreeable to keeping their current antidepressant treatment (if any) constant during the intervention (unless clinically indicated)
    11. Has a close family member, friend, partner, or qualified chaperone able and willing to accompany the patient home after each MST treatment session and
    12. Able to adhere to the intervention schedule.

  • DBT-Only Group

    1. English-speaking and able to provide informed consent to participate in the study
    2. Female and between the ages 18 and 50 years
    3. Current DSM-IV diagnosis of BPD based on the International Personality Disorder Examination BPD Section (IPDE-BPD)
    4. Current DSM-5 diagnosis of a non-psychotic, major depressive episode, as part of a broader diagnosis of MDD (single episode or recurrent episode), based on the Structured Clinical Interview for DSM-IV Axis I Disorders--Patient Edition (SCID-I)
    5. Score > 9 (equivalent to moderate-to-severe suicidal ideation) on the Modified Suicidal ideation Scale for at least the two weeks prior to enrolling in the study
    6. Baseline Hamilton Rating Scale for Depression (HRSD-24) score > 22
    7. Failed to achieve a clinical response to adequate treatment trials of two or more antidepressants during the current depressive episode OR have been unable to tolerate at least two antidepressants as assessed by the Antidepressant Treatment History Form (ATHF)
    8. Agreeable to keeping their current antidepressant treatment (if any) constant during the study (unless clinically indicated)

Exclusion criteria

Exclusion Criteria:

  • MST+DBT Group

    1. Acute suicidal intent that requires hospitalization to protect harm to self
    2. Any unstable medical and/or neurological condition
    3. Currently pregnant or lactating, or intention to get pregnant during the duration of the study
    4. Not considered sufficiently physically healthy to undergo general anesthesia for any reason
    5. Any significant neurological disorder or condition likely to be associated with increased intracranial pressure or cognitive impairment (e.g., a space occupying brain lesion, a history of stroke, a cerebral aneurysm, a seizure disorder, Parkinson's disease, Huntington's chorea, multiple sclerosis)
    6. Medical condition, medication, or laboratory abnormality that could cause a major depressive episode or significant cognitive impairment in the opinion of the investigator (e.g., hypothyroidism with low thyroid-stimulating hormone (TSH), rheumatoid arthritis requiring high dose prednisone, or Cushing's disease)
    7. Current diagnosis of delirium, dementia or another cognitive disorder secondary to a general medical condition
    8. Diagnosis of a developmental disorder (e.g. Down syndrome, autism-spectrum disorder)
    9. Non-correctable sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests)
    10. Lower than eighth-grade reading level as assessed by the Wide Range Achievement Test-Fourth Edition
    11. Alcohol or substance use disorder (relating to opioids or cocaine) currently or within the past 1 month
    12. Diagnosis of a psychotic disorder
    13. Demonstrated a lack of response to ECT during the current or prior depressive episode.
    14. Requires a benzodiazepine with a dose equivalent to lorazepam 2 mg/day or higher or any anticonvulsant due to the potential of these medications to limit the efficacy of both MST and ECT
    15. 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
    16. Has sustained a moderate-to-severe head injury (defined as ≥ 20 min loss of consciousness and/or > 24 hrs post-traumatic amnesia); or
    17. Does not qualify for MRI scanning

  • DBT-Only Group

    1. Acute suicidal intent that requires hospitalization to protect harm to self
    2. Any unstable medical and/or neurological condition
    3. Currently pregnant or lactating, or intention to get pregnant during the duration of the study
    4. Any significant neurological disorder or condition likely to be associated with increased intracranial pressure or cognitive impairment (e.g., a space occupying brain lesion, a history of stroke, a cerebral aneurysm, a seizure disorder, Parkinson's disease, Huntington's chorea, multiple sclerosis)
    5. Medical condition, medication, or laboratory abnormality that could cause a major depressive episode or significant cognitive impairment in the opinion of the investigator (e.g., hypothyroidism with low TSH, rheumatoid arthritis requiring high dose prednisone, or Cushing's disease)
    6. Current diagnosis of delirium, dementia or another cognitive disorder secondary to a general medical condition
    7. Diagnosis of a developmental disorder (e.g. Down syndrome, autism-spectrum disorder)
    8. Non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests)
    9. Lower than eighth-grade reading level as assessed by the Wide Range Achievement Test--Fourth Edition
    10. Alcohol or substance use disorder (relating to opioids or cocaine use) currently or within the past 1 month
    11. Diagnosis of a DSM-5 psychotic disorder
    12. 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
    13. Has sustained a moderate-to-severe head injury (defined as ≥ 20 min loss of consciousness and/or > 24 hrs post-traumatic amnesia)
    14. Does not qualify for MRI scanning
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Other
    DBT Only

    Dialectical behavior therapy (DBT) is a specific type of cognitive-behavioral psychotherapy developed to help better treat borderline personality disorder.

    Behavioral: DBT

  • Experimental
    MagPro MST with Cool TwinCoil + DBT

    MST treatments will be administered using the MagPro MST with Cool TwinCoil. Moderate-to-highly suicidal patients with BPD beginning dialectical behavioural therapy (DBT) will be recruited using a case-control design, comparing individuals receiving MST and DBT with matched patient control group receiving DBT alone.

    Device: MagPro MST with Cool TwinCoil · Behavioral: DBT

Interventions

  • DeviceMagPro MST with Cool TwinCoil

    MST treatments will be administered using the MagPro MST with Cool TwinCoil. The investigators will evaluate the effectiveness of MST for reducing suicidality and depressive symptoms in an open-label clinical trial of up to 15 treatment sessions. Moderate-to-highly suicidal patients with BPD beginning dialectical behavioural therapy (DBT) will be recruited using a case-control design, comparing individuals receiving MST and DBT with matched patient control group receiving DBT alone.

    Also known as: Magnetic Seizure Therapy (MST)

  • BehavioralDBT

    Dialectical behavior therapy (DBT) is a specific type of cognitive-behavioral psychotherapy developed to help better treat borderline personality disorder. Moderate-to-highly suicidal patients with BPD beginning dialectical behavioural therapy (DBT) will be recruited using a case-control design, comparing individuals receiving MST and DBT with matched patient control group receiving DBT alone.

    Also known as: Dialectical behavior therapy (DBT)

06

What researchers measure

Primary outcomes

  1. Improvement in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 24

    Hamilton Rating Scale for Depression (24-item version) * This scale is used to quantify the severity of symptoms of depression * Scale range: 0-76 (total score) * Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) * Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)

    Time frame: 5 weeks

  2. Improvement in symptom severity of Suicidal Ideation as measured by the Modified Scale for Suicidal Ideation

    Modified Scale for Suicidal Ideation * This scale is used to assess the presence or absence of suicidal ideation and the degree of severity of suicidal ideas * Scale range: 0-54 (total score) * Lower scores indicate lower severity of suicidal ideation (i.e., better outcome) * Higher scores indicate higher severity of suicidal ideation (i.e., worse outcome)

    Time frame: 5 weeks

07

Study locations

1 site
  • Centre for Addiction and Mental Health
    Toronto, Ontario M5T 1R8, Canada
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Jun 2020, 32 months.

Of 105 non-industry interventional studies with no phase under Borderline Personality Disorder, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 54. This study's 32 months is close to that.

Counting every sponsor, half of 107 studies reached it within 35 months; a quarter within 24 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 31, 2017
First posted
Dec 5, 2017
StartActual
Oct 17, 2017
Primary completionActual
Jun 24, 2020
CompletionActual
Jun 24, 2020
Last update
Feb 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03361826
Lead sponsor
Centre for Addiction and Mental Health
Responsible party
Daniel Blumberger (Chair, Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health) — Principal investigator
First posted
Dec 5, 2017
Start date
Oct 17, 2017
Primary completion
Jun 24, 2020
Completion
Jun 24, 2020
Last update
Feb 13, 2025

Study contacts

Daniel Blumberger, MD
principal investigator · Centre for Addiction and Mental Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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