A Pilot Trial of One-Day Accelerated TMS and D-cycloserine in Suicidal Patients With Borderline Personality Disorder
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMclean Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
TMS
DeviceTMS 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.
D-Cycloserine (DCS)
DrugParticipants will be asked to take a single dose (250mg) of D-cycloserine the night before the treatment day.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: TMS + D-cycloserineExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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 52
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 sessionSecondary outcomes
1
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 weeks2
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 weeks3
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.
Time frame
From baseline through to week 11. Taken at week 1, week 7, and week 114
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.
Time frame
From baseline through to week 11. Taken at week 1, week 7, and week 11Sponsors and contacts
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Source ClinicalTrials.gov