- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07223619
PILOT Phase: BPD Study
PILOT Study: Treatment of Borderline Personality Disorder by Targeting Ventrolateral Prefrontal-amygdala Circuit With Network-based Neuronavigated Transcranial Magnetic Stimulation
This pilot study aims to identify the area of the brain best suited for the treatment of Borderline Personality disorder (BPD). The study investigators will test whether repetitiveTranscranial Magnetic Stimulation (rTMS), a gentle non-invasive brain stimulation method, can improve regulation of emotions and impulsivity in individuals with BPD.
This study will enroll up to 20 participants. Participant will be consented for the study remotely via a secure internet platform called Zoom. Participants will undergo 1 Magnetic Resonance Imaging or MRI scan and up to 3 brain stimulation of transcranial magnetic stimulation or TMS sessions, and cognitive behavioral testing on a computer.
Participants will complete 4 in-person visits over the course of up to 3 weeks.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Borderline personality disorder (BPD) is a serious neuropsychiatric illness with a prevalence of 1-5% in the general population. Two core symptoms of BPD are emotional dysregulation and increased impulsivity. These dysfunctions are associated with depression, anxiety, and impulsive acts, particularly acts of self-harm that may include suicide. Current treatment options for BPD include specialized psychotherapies and pharmacotherapy, which are of limited benefit for many patients. There is an urgent need for development of novel and more effective treatments.
BPD may arise from dysfunction of brain circuits involved in emotional regulation. A circuit-based treatment such as repetitive Transcranial Magnetic Stimulation (rTMS) holds promise for treatment of BPD. Several recent studies examined rTMS treatment in BPD and found it was well tolerated with encouraging signs of clinical efficacy. Advances in affective neuroscience, combined with progress in brain imaging and neuromodulation technology, make it possible to develop new circuit-based approaches to rTMS that could enhance efficacy for treatment for BPD. Evidence from task- based neuroimaging in BPD showed hyperactivity in the amygdala (a brain structure implicated in the generation of negative emotions) along with diminished top-down prefrontal-amygdala circuit control. These findings suggest that neuroimaging-guided rTMS stimulation of this circuit could enhance emotional regulation and behavioral control in patients with BPD and have greater therapeutic benefit.
This project aims to explore a novel circuit-based rTMS treatment protocol for BPD. 20 subjects with BPD will be recruited and undergo resting-state functional Magnetic Resonance Imaging (fMRI) to identify regions in the right and left ventrolateral prefrontal cortex (VLPFC) having strongest connectivity with the right and left amygdala. These will be used as individualized targets for neuronavigated excitatory intermittent theta burst (iTBS) rTMS of right, left, and bilateral VLPFC. Change in measures of impulse control and emotion regulation will be examined pre-post single rTMS sessions to determine which stimulation target(s) show the greatest VLPFC-amygdala circuit engagement.
The study investigators will examine the effects of right-sided, left-sided, and bilateral VLPFC stimulation in 20 subjects to determine which target(s) show the greatest signal of engagement of the VLPFC-amygdala network.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90024
- Semel Institute/ UCLA TMS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age of 18-65
- DSM-5 Diagnosis of Borderline Personality Disorder (BPD) based upon a psychiatric evaluation and ZAN-BPD scale
- Fluent English speaker
- Ability to give informed consent
Exclusion Criteria:
- Medical conditions that prevent TMS or MRI to be performed safely upon evaluation by the study psychiatrist
- Active alcohol or drug abuse of such severity that it would pose a risk for TMS administration (i.e., unstable motor thresholds or increased risk for seizure)
- Active suicidal plan
- Current diagnosis of Psychotic or Bipolar disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Stimulation to Ventrolateral Prefrontal Cortex
Each subjects will receive Transcranial Magnetic Stimulation or TMS to 3 different brain regions in 3 separate study visits spaced by at least 4 days (order randomized and counterbalanced amongst subjects).
The experimenters will utilize the MagVenture MagPro X100 stimulator equipped with the Cool B70 coil stimulate The TMS protocol includes 1800 pulses of excitatory intermittent theta burst stimulation (iTBS) at 120% MT intensity. This protocol will take less than 9 minutes (for each target). |
Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression.
Using pulsed magnetic fields, transcranial magnetic stimulation therapy stimulates the part of the brain thought to be involved with mood regulation.
These magnetic fields do not directly affect the whole brain; they only reach about 2-3 centimeters into the brain directly beneath the treatment coil.As these magnetic fields move into the brain, they produce very small electrical currents.
These electrical currents activate cells within the brain, causing them to rewire, a process called neuroplasticity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delay Discounting Task (Odum, 2011)
Time Frame: Baseline, Visit 4 (up to 3 weeks)
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The Delay Discounting Task (DDT) is cognitive behavioral task performed to evaluate how individuals value rewards over time.
It measures the tendency of individuals to prefer smaller, immediate rewards over larger, delayed ones.
This behavior is known as delay discounting.
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Baseline, Visit 4 (up to 3 weeks)
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Cognitive Reappraisal of Social Exclusion Pain Task (Zhao et al., 2021)
Time Frame: Baseline, Visit 4 (up to 3 weeks)
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This task involves a comparison between a social exclusion group and a social inclusion group, and uses a pain-induction or pain-stimulus paradigm to measure the effects of social exclusion on individuals' perception and regulation of pain
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Baseline, Visit 4 (up to 3 weeks)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-1207
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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