Treatment of Acute Mood Depressive Episode in Borderline Personality Disorder With rTMS

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT04870255
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Left Dorsolateral Prefrontal Cortex (L-DLPFC) — DEVICE
    Participants who are randomly assigned to this group will receive active iTBS (intermittent theta burst stimulation) to the left DLPFC. Stimulation intensity will be standardized at 90% of resting motor threshold (adjusted for cortical depth). Stimulation will be delivered using the Magventure Magpro X100 TMS system.
  • Dorsomedial Prefrontal Cortex (DMPFC) — DEVICE
    Participants who are randomly assigned to this group will receive active iTBS (intermittent theta burst stimulation) to the DMPFC. Stimulation intensity will be standardized at 100% of resting motor threshold (adjusted for cortical depth). Stimulation will be delivered using the Magventure Magpro X100 TMS system.
  • Sham Stimulation — DEVICE
    Participants who are randomly assigned to this group will receive sham stimulation to the left DLPFC. Sham stimulation will be delivered using the Magventure Magpro X100 TMS system.

Study Details

This study evaluates the antidepressant effects of an accelerated schedule of theta-burst stimulation, termed accelerated intermittent theta-burst stimulation (aiTBS), in individuals with borderline personality disorder (BPD) or trait and comorbid mood depressive disorder (MDD) or bipolar II disorder in a current mood depressive episode (MDE).

Key Dates

First listed
May 3, 2021
Start date
Jul 20, 2021
Status verified
Aug 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Left Dorsolateral Prefrontal Cortex (L-DLPFC)
    The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC)
  • Active Comparator: Dorsomedial Prefrontal Cortex (DMPFC)
    The accelerated theta burst stimulation protocol will be applied to the dorsomedial prefrontal cortex (DMPFC)
  • Sham Comparator: Sham stimulation
    Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC) region

Primary Outcome Measure

Change in the clinician rated Montgomery-Asberg Depression Rating Scale (MADRS-C) in active L-DLPFC vs. sham aiTBS. [ Time Frame: At baseline (pre-intervention), during the intervention and immediately after the intervention. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford HospitalStanfordCalifornia94305
Nick Bassano, MSW1
[email protected]
6504347844
Katina Marchione
[email protected]
David Spiegel, MD (PRINCIPAL_INVESTIGATOR)

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