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

Официальное название

A Pilot Trial of One Day Accelerated Intermittent Theta-burst Stimulation Plus D-cycloserine in Suicidal Patients With Borderline Personality Disorder (ONE-D BPD)

Обзор

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.

Вмешательства

• Устройство TMS
  TMS will consist of 600 pulses of intermittent theta burst stimulation (iTBS), with 3-minute treatment sessions delivered up to 20 times every 30 minutes for a 12-hour protocol.
• Препарат D-Cycloserine (DCS)
  Participants will be asked to take a single dose (250mg) of D-cycloserine the night before the treatment day.

Первичные конечные точки

• Acceptability of Intervention Measure (AIM) [Срок оценки: Week 5]
• Motor-evoked potentials (MEPs) [Срок оценки: Within 10 minutes pre- and 5 minutes post- treatment sessions 1,2,10,and final session]

Вторичные конечные точки (7)

• Modified Scale for Suicide Ideation - Self Report (MSSI-SR) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: From baseline through to week 11. Taken at week 1, week 7, and week 11]
• The Brief Version of the Mentalization Scale (MentS-12) [Срок оценки: From baseline through to week 11. Taken at week 1, week 7, and week 11]
• Social Safeness and Pleasure Scale (SSPS) [Срок оценки: From baseline through to week 11. Taken at week 1, week 7, and week 11]
• Borderline Symptom List 23 (BSL-23) [Срок оценки: From baseline through to week 11. Taken at week 1, week 7, and week 11]
• Patient Health Questionnaire 9 (PHQ-9) [Срок оценки: From baseline through to week 11. Taken at week 1, week 7, and week 11]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• McLean Hospital — Belmont

Идентификаторы

NCT: NCT07460947 · 2025P001818

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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