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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Borderline Personality Disorder (BPD)
• Intervention / Treatment: Device: TMS; Drug: D-Cycloserine (DCS)

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Julia Nolan, BA; Phone Number: 617-855-3430; Email: jnolan7@mgb.org
• Study Contact Backup: Name: Molly Coyle, BS; Phone Number: 617-855-2153; Email: mcoyle3@mgb.org

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital
      • Contact: Julia L Nolan, BA; Email: jnolan7@mgb.org
      • Contact: Molly Coyle, BS; Email: mcoyle3@mgb.org
      • Sub-Investigator: Joshua C Brown, MD PhD
      • Principal Investigator: Jenna M Traynor, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TMS + D-cycloserine; Open-label combination of TMS and D-cycloserine	Device: 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.; Other Names: iTBS; Drug: D-Cycloserine (DCS); Participants will be asked to take a single dose (250mg) of D-cycloserine the night before the treatment day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Within 10 minutes pre- and 5 minutes post- treatment sessions 1,2,10,and final session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	From baseline through to week 11. Taken at week 1, week 7, and week 11
The Brief Version of the Mentalization Scale (MentS-12)	The MentS-12 is a 12-item self-report measure that assesses an individual's mentalization capacity across self-related mentalization, other-related mentalization, and motivation to mentalize. Responses range from 1 (completely incorrect) to 5 (completely correct), and total higher summed score indicates greater mentalizing capacity.	From baseline through to week 11. Taken at week 1, week 7, and week 11
Social Safeness and Pleasure Scale (SSPS)	The SPSS is an 11-item self-report measure that assesses the extent to which participants experience their social worlds as safe, warm, and soothing. Responses range from 1 (almost never) to 5 (almost all the time), and total scores range from 11 to 55, with higher scores indicating greater positive feelings in social relationships.	From baseline through to week 11. Taken at week 1, week 7, and week 11
Borderline Symptom List 23 (BSL-23)	The BSL-23 is a self-report measure that Assesses how much participants suffered from experiences related to BPD. Responses range from 0 (not at all) to 4 (very strong). The total score (0-4) is the average of the 23 items, with higher scores indicating greater BPD symptom severity.	From baseline through to week 11. Taken at week 1, week 7, and week 11
Patient Health Questionnaire 9 (PHQ-9)	The PHQ-9 is a 9-item self-report measure that assesses depression severity over the past 2 weeks (or otherwise specified). Responses range from 0 (not at all) to 3 (nearly every day), along with a final question about how difficult the endorsed problems made it difficult to do work, take care of things at home, or get along with others (ranging from not difficult at all - extremely difficult). Total summed score indicates depression severity, with higher scores suggesting greater depression severity	From baseline through to week 11. Taken at week 1, week 7, and week 11

Collaborators and Investigators

• Sponsor: Mclean Hospital
• Investigators: Principal Investigator: Jenna M Traynor, PhD, McLean Hospital; Principal Investigator: Joshua Brown, MD, PhD, McLean Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Amino Acids; Oxazolidinones; Oxazoles; Isoxazoles; Serine; Amino Acids, Neutral; Cycloserine
• Other Study ID Numbers: 2025P001818

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is an internal, Phase I study and there are no current plans to share IPD with personnel outside of Mass General Brigham (MGB). In the event that a decision is made in the future to share data from this research study with collaborators outside of MGB, data will be de-identified prior to sharing and will comply with all relevant MGB data sharing policies. The possibility that data may be shared with outside collaborators will be clearly outlined in the informed consent form.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No