TMS + D-Cycloserine for Borderline Personality Disorder

(ONE-D BPD Trial)

Overseen By Molly Coyle, BS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Mclean Hospital

Must be taking: D-cycloserine

Disqualifiers: Mania, Psychosis, Substance use, Eating disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with borderline personality disorder (BPD). It combines the medication D-cycloserine with transcranial magnetic stimulation (TMS), a non-invasive procedure using magnetic fields to stimulate brain nerve cells. Researchers aim to determine if this approach can improve symptoms, assess participants' perceptions, and evaluate the longevity of benefits. Suitable participants have a BPD diagnosis and have recently experienced moderate to severe suicidal thoughts. They will engage in interviews, complete questionnaires, and participate in a 12-hour treatment day at the clinic. As a Phase 1, Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have found that TMS (transcranial magnetic stimulation) is generally well-tolerated by individuals with mental health conditions, including borderline personality disorder (BPD). Research shows that TMS treatments can effectively reduce symptoms like impulsivity and mood swings and are safe for these patients.

D-cycloserine, a medication used in other treatments, is generally considered safe, though it can have side effects. This study combines D-cycloserine with TMS to explore a new treatment option for BPD.

Both treatments have shown promising safety records individually, but their combination is still under study to confirm safety and effectiveness for treating BPD. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for borderline personality disorder?

Researchers are excited about the combination of Transcranial Magnetic Stimulation (TMS) and D-cycloserine for treating Borderline Personality Disorder because it offers a fresh approach compared to existing treatments like psychotherapy and medication. TMS is a non-invasive technique that uses magnetic fields to stimulate nerve cells in the brain, potentially offering quicker and more direct effects on mood regulation. D-cycloserine, typically used as an antibiotic, is being repurposed here to enhance the effects of TMS by facilitating learning and memory. This combination could provide a more rapid and effective treatment option than traditional therapies, which often take weeks or even months to show results.

What evidence suggests that this trial's treatments could be effective for borderline personality disorder?

Research has shown that Transcranial Magnetic Stimulation (TMS) can help reduce major symptoms of borderline personality disorder (BPD), such as mood swings and impulsive behavior. Studies indicate that TMS is generally safe, with serious side effects uncommon. In this trial, participants will receive a combination of TMS and D-cycloserine, a medication that might enhance its effectiveness. For instance, one study found an 87% success rate when this combination was used for depression, suggesting it might also work well for BPD. Although more research is needed, these findings offer hope for those seeking new treatment options for BPD. ^{1 2 6 7 8}

Who Is on the Research Team?

Jenna M Traynor, PhD

Principal Investigator

Mclean Hospital

Joshua Brown, MD, PhD

Principal Investigator

Mclean Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

I have had moderate to severe suicidal thoughts in the past two weeks.

I am 18 years old or older.

* Meets DSM-5 criteria for BPD, per assessment with the Structured Clinic Interview for DSM-5 Personality Disorders (SCID-5-PD), BPD Module

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Participants complete weekly questionnaires for 4 weeks before the treatment day

4 weeks

Weekly virtual questionnaires

Treatment

Participants take D-cycloserine the night before treatment and attend one treatment day at the clinic for up to 20 short TMS sessions

1 day

1 visit (in-person, up to 12 hours)

Follow-up

Participants complete weekly questionnaires for 6 weeks after the treatment day

6 weeks

Weekly virtual questionnaires

What Are the Treatments Tested in This Trial?

Interventions

• D-Cycloserine
• Transcranial Magnetic Stimulation (TMS)

How Is the Trial Designed?

Group I: TMS + D-cycloserine Experimental Treatment 2 Interventions

Open-label combination of TMS and D-cycloserine

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials

221

Recruited

22,500+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07227103

Study Details | NCT07227103 | A Randomized, Double ...

When the AMPA one day (ONE-D) TMS protocol was combined with DCS, the measured response rate was 87% at one week. This trial will compare response and remission ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12438649/

Efficacy of transcranial magnetic stimulation in borderline ...

In conclusion, Transcranial Magnetic Stimulation leads to significant reductions in main symptoms, such as mood swings, impulsivity, aggressiveness, emotional ...

3.

tmsjournal.org

tmsjournal.org/article/S3050-5291(25)00072-8/fulltext

TMS Effectiveness as Treatment for Patients With Comorbid ...

Every study except for a single outlier indicated significant improvement in depression symptoms, whereas only 50% of the studies that observed BPD symptoms ...

4.

neuromodulation.ucla.edu

neuromodulation.ucla.edu/wp-content/uploads/2023/02/pulse-jan-2023.pdf

A Monthly Update on Advances in Neuromodulation

Adjunctive D-Cycloserine. May Enhance iTBS. Outcomes in Patients with. MDD. High-Frequency rTMS. Improves Depression and. Insomnia More than Sham.

5.

researchgate.net

researchgate.net/publication/387444694_Real-world_effectiveness_of_a_single-day_regimen_for_transcranial_magnetic_stimulation_using_Optimized_Neuroplastogen-Enhanced_techniques_in_Depression_ONE-D

(PDF) Real-world effectiveness of a single-day regimen for ...

Response / remission rates (cross-sectional, not aggregated) were 90.3% and 74.2% (HDRS-17), 93.5% and 71.0% (BDI-II), 90.3% and 58.1% (PHQ-9), ...

6.

tmsjournal.org

tmsjournal.org/article/S3050-5291(25)00100-X/pdf

Transcranial Magnetic Stimulation

The findings suggest the benefits of iTBS treatment and support further exploration of patient characteristics that may predict response to.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S1388245724003766

Consensus review and considerations on TMS to treat ...

TMS continues to demonstrate broad evidence for safety and efficacy in treating depression. Newer forms of TMS are faster and potentially more effective.

8.

researchgate.net

researchgate.net/publication/353755869_Repetitive_transcranial_magnetic_stimulation_in_patients_with_borderline_personality_disorder_A_systematic_review

Repetitive transcranial magnetic stimulation in patients with ...

The literature on the application of repetitive transcranial magnetic stimulation (rTMS) in Borderline Personality Disorder (BPD) is unclear ...