Combining Transcranial Magnetic Stimulation With Emotion Regulation Skills Training in Borderline Personality Disorder

NCT07714005 | Not Yet Recruiting FDA Device

• 1 other identifier: 2026P001257
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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)

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Client Satisfaction Questionnaire (CSQ)

  Self-report measure of participant satisfaction with the interventions

  From baseline to end of acute treatment at 8 weeks

• UP Module Completion Rate

  Measure of percentage of emotion skills training modules completed

  From enrollment to the end of treatment at 8 weeks

• Session Completion Rate

  Measure of percentage of study visits attended

  From baseline to end of acute treatment at 8 weeks

Secondary Outcomes (6)

• Emotion Regulation Skills Questionnaire (ERSQ)

  Baseline through acute treatment end at 8 weeks

• Borderline Evaluation of Severity Over Time (BEST)

  Baseline through acute treatment end at 8 weeks

• Affective Multi-Source Interference Task (MSIT-IAPS)

  Baseline through acute treatment end at 8 weeks

• Delay-Discounting Task (DDT)

  Baseline through acute treatment end at 8 weeks

• Cyberball Social Rejection Task (CSRT)

  Baseline through acute treatment end at 8 weeks

Study Arms (1)

TMS+UP

EXPERIMENTAL

Combined accelerated TMS and emotion regulation skills training

Device: Transcranial Magnetic Stimulation (TMS); Behavioral: Emotion Regulation Skills Training

Interventions

Emotion Regulation Skills Training BEHAVIORAL

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

Also known as: Unified Protocol, UP, cognitive behavioral therapy, CBT

TMS+UP

Transcranial Magnetic Stimulation (TMS) DEVICE

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

Also known as: TMS, iTBS, aiTBS

TMS+UP

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Borderline Personality Disorder; Emotional Regulation

Interventions

Transcranial Magnetic Stimulation; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Kristen K Ellard, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristen K Ellard, Ph.D.

CONTACT

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

Chandler Carr

CONTACT

ccarr16@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share