A Pilot Trial of One-Day Accelerated TMS and D-cycloserine in Suicidal Patients With Borderline Personality Disorder

Phase 2Not Yet RecruitingNCT07460947

Mclean Hospital20 enrolled

Overview

This study tests a new treatment for people with borderline personality disorder (BPD). The treatment combines a medication called D-cycloserine with one day of transcranial magnetic stimulation (TMS). The main questions it aims to answer are: * How many participants complete the treatment? * How do participants feel about the treatment? * Does the treatment have neurophysiological changes on participants? * Does the treatment improve BPD symptoms? * Do the benefits last over time? Participants will be asked to: * Come to the clinic for interviews and testing * Complete weekly questionnaires for 4 weeks before the treatment day * Take D-cycloserine the night before treatment * Attend one treatment day at the clinic. On that day, they may receive up to 20 short TMS sessions (each lasting 3 minutes and separated by 30 minutes). This visit may last up to 12 hours. * Complete weekly questionnaires for 6 weeks after the treatment day.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Borderline Personality Disorder (BPD)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult (18+) of any gender * Meets DSM-5 criteria for BPD, per assessment with the Structured Clinic Interview for DSM-5 Personality Disorders (SCID-5-PD), BPD Module * Moderate to severe SI during the two weeks prior to screening, as indexed by a score of 9 or higher on the Modified Scale for Suicide Ideation - Self Report (Clum \& Yang, 1995) Exclusion Criteria: * Current manic or hypomanic symptoms, as assessed by the Diagnostic Assessment Research Tool (DART) screener and diagnostic modules, where relevant. * Current clinically significant psychotic symptoms not better accounted for by BPD, as assessed by the DART psychotic symptoms screener. * Current alcohol or substance use disorder, that in the opinion of a study PIs, is of sufficient severity to impede engagement in treatment or is associated with significant risk of medical withdrawal, as assessed by the DART. * Medical documentation or self-report of current anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified - atypical anorexia nervosa or atypical bulimia nervosa, that is in the opinion of a study PIs is of sufficient severity to be associated with significant medical risks * Acute suicide risk, sufficient to require immediate hospitalization; * history of traumatic brain injury (TBI) or concussion involving loss of consciousness or amnesia for ≥24 hours; * any significant neurological disorder likely to be associated with increased intracranial pressure or cognitive impairment (e.g., epilepsy; Parkinson's disease); * diagnosed neurodevelopmental disorder (e.g., autism, downs syndrome; Ehlers-Danlos Syndrome) other than attention-deficit hyperactivity disorder (ADHD) or dyslexia * current diagnosis of delirium or dementia; * cognitive disorder secondary to a general medical condition * Pregnant and breastfeeding people are excluded in line with the studies our protocol is based upon using DCS and aTMS. Assessment of pregnancy will be completed during the 1-week prior to the administration of DCS (i.e., taken the night before TMS treatment), where relevant and according to MGB IRB policy. * Participants with contraindications to TMS (e.g., metal in head or neck area), or at increased risk for adverse events (e.g., seizure history or markedly heightened risk factors for seizures, serious medical problems, implanted devices) will be excluded. * Participants with a known allergy to DCS will be excluded from the study. * No patients with involuntary hospitalization status will be recruited for the study. * No individuals who are not proficient in English will be recruited for the study * Subject does not have a PCP

Outcomes

Primary Outcomes

Acceptability of Intervention Measure (AIM)

Feasibility of the one-day TMS treatment will be indexed by favorable ratings on the Acceptability of Intervention Measure (AIM). The AIM is a four-item measure that assesses participants' approval of an intervention. Each item is rated on a 5-point scale (completely disagree - completely agree), and total scores indicate greater acceptance of an intervention.

Time frame: Week 5

Motor-evoked potentials (MEPs)

MEPS will be recorded before and after treatment sessions 1, 2, 10, and the final session. Specifically, MEPS will be collected within 10 minutes before treatment session onset and within 5 minutes after treatment session completion. An increase in motor-evoked potentials (MEPs) over the TMS treatment course indicates increased plasticity.

Time frame: Within 10 minutes pre- and 5 minutes post- treatment sessions 1,2,10,and final session

Secondary Outcomes

Modified Scale for Suicide Ideation - Self Report (MSSI-SR)

Suicidal ideation will be assessed using the MSSI-SR. The MSSI-SR is an 18-item self-report measure that assesses the frequency, intensity, and nature of suicidal ideation, plans, and intent across the past week. Responses range from 0 (e.g., does not experience thoughts of suicide) to 3 (e.g., experiences thoughts of suicide many times each day). Total score ranges from 0 to 54, with higher scores indicating greater suicide risk factors and more severe suicidal ideation.

Time frame: From baseline through to week 11. Taken at week 1, week 3, week 6, week 8, week 10, and week 11, an average of once every two weeks

Distress Tolerance Scale (DTS)

The DTS is a 15-item self-report questionnaire assessing participant's beliefs about distressing or upsetting feelings on average. Responses range from 1 (strongly agree) to 5 (strongly disagree), and higher average total scores indicate greater distress tolerance.

Time frame: From baseline through to week 11. Taken at week 1, week 2, week 4, week 7, week 9, and week 11, an average of once every two weeks

Rejection Sensitivity Questionnaire (RSQ)

The RSQ is an 18-item self-report measure that assesses the level of rejection concern and rejection expectancy an individual has in nine common hypothetical situations. Rejection concern scores range from 1 (very unconcerned) to 6 (very concerned), and rejection expectancy scores range from 1 (very unlikely) to 6 (very likely). Sensitivity scores (between 1 and 36) are produced for each situation by multiplying the two scores. The total score (between 1 and 36) represents the average of rejection sensitivity scores across the situations, with higher scores indicating greater rejection sensitivity.