Recruiting

TMS & Skills Training

Sponsor:

Massachusetts General Hospital

Code:

NCT07714005

Conditions

Borderline Personality Disorder (BPD)

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Interventions

Transcranial Magnetic Stimulation (TMS)

Emotion Regulation Skills Training

Study Details

Brief summary:

Impaired emotion regulation is a core feature of borderline personality disorder (BPD) and a known driver of functional impairment, interpersonal difficulties, self-harm, and suicidality. Emotion regulation refers to the ways in which people influence and control which emotions they have, when they have them, and how they experience and express them. Effective emotion regulation is a precursor to success in a range of adaptive processes including decision making, impulse control, communication and social interaction, work performance and productivity, and goal achievement, with subsequent positive effects on mood stability and well-being.

Front-line behavioral approaches to teach effective emotion regulation skills in BPD (e.g. DBT) have been moderately successful, but outcomes are limited by high dropout rates due to lengthy treatment protocols and pre-existing deficits in the neurocircuitry supporting engagement in emotion regulation, with poorer outcomes in individuals with more severe emotion dysregulation.

In this pilot feasibility trial, we aim to test an approach to improving emotion dysregulation in BPD by combining neuromodulation using transcranial magnetic stimulation (TMS), to improve functioning of emotion regulation related neurocircuitry, with an intensive, brief emotion regulation skills training protocol. Through this combined approach, we hypothesize increased gains in emotion regulation ability, decreased treatment dropout rates, and improved positive outcomes in patients with BPD.

Conditions

Borderline Personality Disorder (BPD)

Study ID

NCT07714005

Start date

Sep 1, 2026

Status verified date

Oct, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • DSM-5 diagnosis of borderline personality disorder;
  • Clinical levels of emotion dysregulation as determined by a score ≥ 80 on the DERS;
  • Male and female sex as assigned at birth;
  • ages 22-65;
  • able to provide informed consent and provide verifiable contact information;
  • stable medication regimen.

Exclusion Criteria:

  • current active suicidality (suicidal ideation with intent or plan)
  • current substance use disorder for the past 6 months (substance use disorder in remission permitted);
  • history of psychosis;
  • dementia or other major neurological disorders
  • medical illness or non-psychiatric medical treatment that would likely interfere with study participation;
  • contraindications for MRI or TMS, including the presence of metallic implants that would interfere with safety (i.e. cardiac pacemaker, metal plates, non-removable body piercings, etc.), history of seizure disorder, history of head trauma;
  • a clinical course of a neuromodulatory therapy (e.g. TMS, tDCS, ECT) within the past 6 months;
  • current use of benzodiazepines (can interfere with iTBS stimulation);
  • current pregnancy, to limit potential risks to an unborn child;
  • concurrent participation in cognitive behavioral therapy (CBT) or dialectical behavioral therapy (DBT) during participation ER-skills training portion of study.
  • non-English speaking (ER skills training delivered in English only)

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TMS+UP

Combined accelerated TMS and emotion regulation skills training

Interventions

Transcranial Magnetic Stimulation (TMS)

accelerated (multi-session) intermittent theta-burst transcranial magnetic stimulation (aiTBS)

Emotion Regulation Skills Training

Cognitive behavioral therapy based emotion regulation skills training using the Unified Protocol

Primary outcome measure

  • Client Satisfaction Questionnaire (CSQ) [ Time Frame: From baseline to end of acute treatment at 8 weeks ]
  • UP Module Completion Rate [ Time Frame: From enrollment to the end of treatment at 8 weeks ]
  • Session Completion Rate [ Time Frame: From baseline to end of acute treatment at 8 weeks ]

Central Contacts and Locations

Central contacts

Kristen K Ellard, Ph.D.

617-724-3221kellard@mgh.harvard.edu

Chandler Carr

ccarr16@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Kristen Ellard, PhD

617-724-3221kellard@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Keywords

  • Borderline Personality Disorder
  • Transcranial Magnetic Stimulation
  • Emotion Regulation
  • Emotion Regulation Skills Training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.