Borderline Personality Disorder (BPD)TMS and TBSNCT07919587
Repetitive Transcranial Magnetic Stimulation Versus Theta Burst Stimulation on Impulsivity, Emotional Dysregulation, and Non-Suicidal Self-Injury in Borderline Personality Disorder Patients
A study testing Repetitive Transcranial Magnetic Stimulation and Intermittent Theta-Burst Stimulation in people with Borderline Personality Disorder (BPD), run by Ain Shams University at 1 site in Egypt.
Trial summary
the goal of this randomized clinical trial is to evaluate the therapeutic efficacy of repetitive transcranial magnetic stimulation (rTMS) and intermittent theta-burst stimulation (iTBS) in patients with borderline personality disorder (BPD). Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Borderline Personality Disorder (BPD)
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation and Intermittent Theta-Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Age range: 21-50 years old. 2. Gender: males and females 3. Borderline personality disorder diagnosis
Who cannot join
- 1. Presence of other uncontrolled mental illness that precludes the ability to provide informed consent (e.g.; acute psychosis, bipolar disorder currently in manic episode, major depressive disorder with recent suicidal attempt).
- 2. Patients with contraindications to TMS as cardiac patients with pacemakers, metallic implants as cochlear implants, aneurysm clips, stents, and deep brain stimulation electrodes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ainshams University Hospitals
Cairo, Cairo Governorate, 11252
dina h abouelleil, msc of neuropsychiatry, +201062229030, Dinahussein@med.asu.edu.eg
About this study
Official title: Effect of Repetitive Transcranial Magnetic Stimulation Versus Theta Burst Stimulation on Impulsivity, Emotional Dysregulation, and Non-Suicidal Self-Injury in a Sample of Patients With Borderline Personality Disorder: A Randomized Controlled Trial
the goal of this randomized clinical trial is to evaluate the therapeutic efficacy of repetitive transcranial magnetic stimulation (rTMS) and intermittent theta-burst stimulation (iTBS) in patients with borderline personality disorder (BPD). The study aims to assess whether these brain stimulation techniques can reduce symptoms of emotional dysregulation, impulsivity, and non-suicidal self-injury.
The main questions it aims to answer are:
Read more
Does high-frequency rTMS over the left dorsolateral prefrontal cortex (DLPFC) improve emotional dysregulation, impulsivity, and non-suicidal self-injury in patients with BPD? Does intermittent theta-burst stimulation (iTBS) over the left DLPFC produce similar therapeutic effects? How does the efficacy of rTMS and iTBS compare to sham stimulation after completing the treatment course?
Participants will be randomly assigned to one of three groups:
- High-frequency rTMS group
- Intermittent theta-burst stimulation (iTBS) group
- Sham stimulation group Each participant will receive 15-20 stimulation sessions over the left DLPFC. Changes in emotional dysregulation, impulsivity, and non-suicidal self-injury symptoms will be evaluated before and after treatment.
Read the detailed description
Borderline Personality Disorder (BPD) is a complex psychiatric condition characterized by emotional dysregulation, impulsivity, and recurrent non-suicidal self-injury (NSSI).
Although psychotherapy and pharmacological interventions remain the mainstay of treatment, many patients continue to experience severe emotional instability and impulsivity. Neuromodulation techniques such as repetitive transcranial magnetic stimulation (rTMS) and theta burst stimulation (TBS) have recently shown promise in modulating fronto-limbic circuits involved in emotion regulation.
This prospective, randomized, double-blind, controlled clinical trial aims to evaluate and compare the therapeutic efficacy of high-frequency rTMS and intermittent theta-burst stimulation (iTBS) applied over the left dorsolateral prefrontal cortex (DLPFC) in patients diagnosed with BPD. The interventions are expected to enhance prefrontal modulation of limbic activity, thereby improving emotional regulation, reducing impulsivity, and decreasing non-suicidal self-injury behaviors.
Participants will be randomly assigned to one of three groups:
Group 1: High-frequency rTMS (5 Hz, 1200 pulses/session, 80-110% RMT, 21 min total) Group 2: Intermittent theta-burst stimulation (iTBS, 50 Hz bursts, 600 pulses/session, 80-120% RMT, 21 min total) Group 3: Sham stimulation (matched duration and sound without magnetic output) All participants will continue their standard therapy for BPD, including weekly Dialectical Behavior Therapy (DBT) sessions during the study. Each participant will receive 20 sessions over 4 weeks (5 sessions per week). Allocation concealment will be ensured using sealed, numbered envelopes prepared by an independent administrator, and both participants and assessors will be blinded to group assignment.
Clinical assessments will include:
Structured Clinical Interview for DSM-IV Axis II Disorders (SCID-II) for BPD diagnosis General Health Questionnaire (GHQ-28) to screen for psychiatric comorbidities Difficulties in Emotion Regulation Scale - Short Form (DERS-16) Barratt Impulsiveness Scale (BIS) Deliberate Self-Harm Inventory (DSHI) Measurements will be taken at baseline (pre-intervention) and after completion of the stimulation sessions (post-intervention).
Safety procedures will follow international TMS safety guidelines (Rossi et al., 2009; Lefaucheur et al., 2020). Adverse effects such as transient headache or scalp discomfort will be monitored, and any serious adverse events (e.g., seizures) will be immediately reported to the Research Ethics Committee.
This study seeks to determine whether rTMS or iTBS is more effective than sham stimulation in improving emotion regulation, reducing impulsivity, and decreasing self-harm behaviors. It will also explore whether iTBS, with its shorter session duration, provides a comparable or superior therapeutic benefit to conventional rTMS.
- Conditions
- Borderline Personality Disorder (BPD)
- Being tested
- Repetitive Transcranial Magnetic Stimulation, Intermittent Theta-Burst Stimulation, Sham Stimulation
- Keywords
- borderline personality disorder, impulsivity, emotional dysregulation, Non-Suicidal Self-Injury
- Medical subject headings
- Borderline Personality Disorder, Impulsive Behavior, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Also called rTMS
rTMS will be delivered at 5 Hz frequency, 1200 pulses per session, at 80-110% of the individual's resting motor threshold (RMT). Stimulation will be applied to the left DLPFC (F3 according to the 10-20 EEG system) using a figure-of-eight coil. Each session includes 18 minutes of active stimulation followed by 3 minutes of sham stimulation on the target site. Sessions are administered 5 days per week for 4 weeks (total 20 sessions).
Intermittent Theta-Burst StimulationDevice
Also called iTBS
iTBS will be delivered as 50 Hz bursts (three pulses per burst, 5 Hz bursts) at 80-120% of resting motor threshold, totaling 600 pulses per session. Stimulation will be applied over the left DLPFC (F3 site, 10-20 EEG system). Each session includes 3 minutes of active iTBS and 18 minutes of sham stimulation. Sessions are administered 5 days per week for 4 weeks (total 20 sessions).
Sham StimulationDevice
Sham stimulation will be delivered using the same coil orientation and acoustic cues as the active conditions, but with the magnetic field output disabled. Each session includes 18 minutes of sham rTMS and 3 minutes of sham TBS over the left DLPFC (F3 site). Sessions are administered 5 days per week for 4 weeks (total 20 sessions).
| Study group | Role | What they receive |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation | Active comparator | Participants receive 15-20 sessions of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC). Each session lasts approximately 21 minutes. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| Intermittent Theta-Burst Stimulation Group | Active comparator | Participants receive 15-20 sessions of intermittent theta-burst stimulation (iTBS) over the left dorsolateral prefrontal cortex (DLPFC). Each session lasts approximately 21 minutes. Receives: Device: Intermittent Theta-Burst Stimulation |
| Sham Stimulation Group | Sham comparator | Participants receive sham stimulation sessions identical in duration and sound to the active conditions but without active magnetic output. Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of impulsivity in BPD as assessed by barratt impulsivity scale (BIS)
Improvement of results of The barratt impulsivity scale (BIS) measured before starting sessions and after finishing 20 sessions
Measured: 20 sessions given over 1 month
Secondary outcomes (2)
improvement of emotional dysregulation as per Difficulties in Emotion Regulation Scale(DERS)
Improvement of results of DERS measured before starting sessions and after finishing 20 sessions
Measured: 20 sessions1 month
improvement of non-suicidal self injury
Improvement of results of The Deliberate Self-Harm Inventory (DSHI) measured before starting sessions and after finishing 20 sessions
Measured: 20 sessions given in 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality Disorder (BPD)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three parallel arms: (1) high-frequency rTMS over the left dorsolateral prefrontal cortex (DLPFC), (2) intermittent theta-burst stimulation (iTBS) over the left DLPFC, or (3) sham stimulation. Each group will receive 15-20 treatment sessions.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina ussein, Ain Shams University
- Investigators
- mohamed F professor Dr, MD of psychiatry, Study director, ainshams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919587
- Sponsor's protocol ID
- FMASU MD169/2025
- Acronym
- TMS and TBS
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: de-identified individual participant data will be available upon reasonable request after publication of the primary results
Publications
Kujovic M, Bahr C, Riesbeck M, Benz D, Wingerter L, Deiss M, Margittai Z, Reinermann D, Plewnia C, Meisenzahl E. Effects of intermittent theta burst stimulation add-on to dialectical behavioral therapy in borderline personality disorder: results of a randomized, sham-controlled pilot trial. Eur Arch Psychiatry Clin Neurosci. 2025 Dec;275(8):2301-2314. doi: 10.1007/s00406-024-01901-0. Epub 2024 Sep 19.
PubMed 39297977
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repetitive Transcranial Magnetic Stimulation Versus Theta Burst Stimulation on Impulsivity, Emotional Dysregulation, and Non-Suicidal Self-Injury in a Sample of Patients With Borderline Personality Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07919587
- Acronym / sponsor ID
- TMS and TBS / FMASU MD169/2025
- Conditions
- Borderline Personality Disorder (BPD)
- Keywords
- borderline personality disorder, impulsivity, emotional dysregulation, Non-Suicidal Self-Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the goal of this randomized clinical trial is to evaluate the therapeutic efficacy of repetitive transcranial magnetic stimulation (rTMS) and intermittent theta-burst stimulation (iTBS) in patients with borderline personality disorder (BPD). The study aims to assess whether these brain stimulation techniques can reduce symptoms of emotional dysregulation, impulsivity, and non-suicidal self-injury.
The main questions it aims to answer are:
Does high-frequency rTMS over the left dorsolateral prefrontal cortex (DLPFC) improve emotional dysregulation, impulsivity, and non-suicidal self-injury in patients with BPD? Does intermittent theta-burst stimulation (iTBS) over the left DLPFC produce similar therapeutic effects? How does the efficacy of rTMS and iTBS compare to sham stimulation after completing the treatment course?
Participants will be randomly assigned to one of three groups:
- High-frequency rTMS group
- Intermittent theta-burst stimulation (iTBS) group
- Sham stimulation group Each participant will receive 15-20 stimulation sessions over the left DLPFC. Changes in emotional dysregulation, impulsivity, and non-suicidal self-injury symptoms will be evaluated before and after treatment.
Detailed description
Borderline Personality Disorder (BPD) is a complex psychiatric condition characterized by emotional dysregulation, impulsivity, and recurrent non-suicidal self-injury (NSSI).
Although psychotherapy and pharmacological interventions remain the mainstay of treatment, many patients continue to experience severe emotional instability and impulsivity. Neuromodulation techniques such as repetitive transcranial magnetic stimulation (rTMS) and theta burst stimulation (TBS) have recently shown promise in modulating fronto-limbic circuits involved in emotion regulation.
This prospective, randomized, double-blind, controlled clinical trial aims to evaluate and compare the therapeutic efficacy of high-frequency rTMS and intermittent theta-burst stimulation (iTBS) applied over the left dorsolateral prefrontal cortex (DLPFC) in patients diagnosed with BPD. The interventions are expected to enhance prefrontal modulation of limbic activity, thereby improving emotional regulation, reducing impulsivity, and decreasing non-suicidal self-injury behaviors.
Participants will be randomly assigned to one of three groups:
Group 1: High-frequency rTMS (5 Hz, 1200 pulses/session, 80-110% RMT, 21 min total) Group 2: Intermittent theta-burst stimulation (iTBS, 50 Hz bursts, 600 pulses/session, 80-120% RMT, 21 min total) Group 3: Sham stimulation (matched duration and sound without magnetic output) All participants will continue their standard therapy for BPD, including weekly Dialectical Behavior Therapy (DBT) sessions during the study. Each participant will receive 20 sessions over 4 weeks (5 sessions per week). Allocation concealment will be ensured using sealed, numbered envelopes prepared by an independent administrator, and both participants and assessors will be blinded to group assignment.
Clinical assessments will include:
Structured Clinical Interview for DSM-IV Axis II Disorders (SCID-II) for BPD diagnosis General Health Questionnaire (GHQ-28) to screen for psychiatric comorbidities Difficulties in Emotion Regulation Scale - Short Form (DERS-16) Barratt Impulsiveness Scale (BIS) Deliberate Self-Harm Inventory (DSHI) Measurements will be taken at baseline (pre-intervention) and after completion of the stimulation sessions (post-intervention).
Safety procedures will follow international TMS safety guidelines (Rossi et al., 2009; Lefaucheur et al., 2020). Adverse effects such as transient headache or scalp discomfort will be monitored, and any serious adverse events (e.g., seizures) will be immediately reported to the Research Ethics Committee.
This study seeks to determine whether rTMS or iTBS is more effective than sham stimulation in improving emotion regulation, reducing impulsivity, and decreasing self-harm behaviors. It will also explore whether iTBS, with its shorter session duration, provides a comparable or superior therapeutic benefit to conventional rTMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel arms: (1) high-frequency rTMS over the left dorsolateral prefrontal cortex (DLPFC), (2) intermittent theta-burst stimulation (iTBS) over the left DLPFC, or (3) sham stimulation. Each group will receive 15-20 treatment sessions.
| Arm | Type | Receives |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation | Active comparator | Device: Repetitive Transcranial Magnetic StimulationParticipants receive 15-20 sessions of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC). Each session lasts approximately 21 minutes. |
| Intermittent Theta-Burst Stimulation Group | Active comparator | Device: Intermittent Theta-Burst StimulationParticipants receive 15-20 sessions of intermittent theta-burst stimulation (iTBS) over the left dorsolateral prefrontal cortex (DLPFC). Each session lasts approximately 21 minutes. |
| Sham Stimulation Group | Sham comparator | Device: Sham StimulationParticipants receive sham stimulation sessions identical in duration and sound to the active conditions but without active magnetic output. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Age range: 21-50 years old. 2. Gender: males and females 3. Borderline personality disorder diagnosis
Key exclusion criteria (2 listed)
- 1. Presence of other uncontrolled mental illness that precludes the ability to provide informed consent (e.g.; acute psychosis, bipolar disorder currently in manic episode, major depressive disorder with recent suicidal attempt).
- 2. Patients with contraindications to TMS as cardiac patients with pacemakers, metallic implants as cochlear implants, aneurysm clips, stents, and deep brain stimulation electrodes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationAlso: rTMSrTMS will be delivered at 5 Hz frequency, 1200 pulses per session, at 80-110% of the individual's resting motor threshold (RMT). Stimulation will be applied to the left DLPFC (F3 according to the 10-20 EEG system) using a figure-of-eight coil. Each session includes 18 minutes of active stimulation followed by 3 minutes of sham stimulation on the target site. Sessions are administered 5 days per week for 4 weeks (total 20 sessions). | Device | Repetitive Transcranial Magnetic Stimulation |
| Intermittent Theta-Burst StimulationAlso: iTBSiTBS will be delivered as 50 Hz bursts (three pulses per burst, 5 Hz bursts) at 80-120% of resting motor threshold, totaling 600 pulses per session. Stimulation will be applied over the left DLPFC (F3 site, 10-20 EEG system). Each session includes 3 minutes of active iTBS and 18 minutes of sham stimulation. Sessions are administered 5 days per week for 4 weeks (total 20 sessions). | Device | Intermittent Theta-Burst Stimulation Group |
| Sham StimulationSham stimulation will be delivered using the same coil orientation and acoustic cues as the active conditions, but with the magnetic field output disabled. Each session includes 18 minutes of sham rTMS and 3 minutes of sham TBS over the left DLPFC (F3 site). Sessions are administered 5 days per week for 4 weeks (total 20 sessions). | Device | Sham Stimulation Group |
Primary outcome
improvement of impulsivity in BPD as assessed by barratt impulsivity scale (BIS)
Time frame: 20 sessions given over 1 month
Improvement of results of The barratt impulsivity scale (BIS) measured before starting sessions and after finishing 20 sessions
2 secondary outcomes
improvement of emotional dysregulation as per Difficulties in Emotion Regulation Scale(DERS)
Time frame: 20 sessions1 month
improvement of non-suicidal self injury
Time frame: 20 sessions given in 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 39297977Kujovic M, Bahr C, Riesbeck M, Benz D, Wingerter L, Deiss M, Margittai Z, Reinermann D, Plewnia C, Meisenzahl E. Effects of intermittent theta burst stimulation add-on to dialectical behavioral therapy in borderline personality disorder: results of a randomized, sham-controlled pilot trial. Eur Arch Psychiatry Clin Neurosci. 2025 Dec;275(8):2301-2314. doi: 10.1007/s00406-024-01901-0. Epub 2024 Sep 19.
- Individual participant dataSharing planned: Yes. de-identified individual participant data will be available upon reasonable request after publication of the primary results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
mohamed F professor Dr, MD of psychiatry study director
ainshams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation and Intermittent Theta-Burst Stimulation in people with Borderline Personality Disorder (BPD), run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact dina h abouelleil, Masters of neuropsychiatry (+201062229030, dinahussein@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of impulsivity in BPD as assessed by barratt impulsivity scale (BIS) (time frame: 20 sessions given over 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07919587, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.