Borderline Personality DisorderNCT04722510
Effect of Repeated Transcranial Magnetic Stimulation on Aggressive Impulsive Behavior in Patients With Borderline Personality Disorder in a Social Exclusion Paradigm.
A study testing repeated transcranial magnetic stimulation in people with Borderline Personality Disorder, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 1 site in Mexico.
Trial summary
Patients with a main diagnosis of borderline personality disorder will be recruited and will be randomized for the application of low frequency repeated transcranial magnetic stimulation (rTMS) protol or sham rTMS protocol. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- repeated transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteMexico
- Study dates
- 21 Jan 2021to 21 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Outpatient consultant in the Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz.
- Main diagnosis of borderline personality disorder according to DSM-IV-TR.
- In the case of having some type of pharmacological treatment using SSRIs, antipsychotics and / or anticonvulsants, this should be maintained without modifications for at least 2 weeks prior to the start of the study and during the follow-up period.
- Comorbidity with some other personality disorder according to the SCID-II, with the exception of antisocial personality disorder.
- Acceptance of participation in the study by signing the informed consent.
Who cannot join
- Subjects who did not agree to participate.
- Diagnosis of current antisocial personality disorder, bipolar disorder, psychotic disorders, severe major depressive episode, substance use disorder (except nicotine), and post-traumatic stress disorder.
- Presence of any comorbid neurological disorder.
- Diagnosis of intellectual disability.
- Subjects in whom the use of rTMS is contraindicated: history of seizures, pregnancy, presence of pacemaker, heart disease, and presence of a metallic object.
- Electroencephalographic evidence of some type of abnormality in the excitability of the central nervous system (dysrhythmias, paroxysmal activity, graphical elements suggestive of epileptic activity, etc.).
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Psiquiatria Ramon de la Fuente Muñiz
Mexico City, Mexico City, 14370
Jorge J Gonzalez Olvera, MD PhD, +5215515107370, jjgonz@gmail.com
Andres Rodriguez Delgado, MD, +525532250714, andres_rode@hotmail.com
About this study
Patients with a main diagnosis of borderline personality disorder will be recruited and will be randomized for the application of low frequency repeated transcranial magnetic stimulation (rTMS) protol or sham rTMS protocol. A pre-treatment and post-treatment measurement of the severity of BPD symptoms, impulsivity, and aggressive behavior will be carried out in all participants using self-administered questionnaires. All participants will be asked to participate in a passing ball game (Cyberball) with the intention of investigating aspects related to social inclusion / exclusion and measurements will be made regarding planning using the maze test. Participation in the Cyberball and the assessment of the planning will be carried out before and after the application of the treatment protocol.
- Conditions
- Borderline Personality Disorder
- Being tested
- repeated transcranial magnetic stimulation
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repeated transcranial magnetic stimulationDevice
Transcranial magnetic stimulation is a non-invasive brain modulation technique that has proven to be a useful study and treatment tool in neuropsychiatric disorders. This technique allows to increase (with high frequency protocol, > 1 Hz) or decrease (with low frecuency protocols, 1 hz or less) neuronal excitability in a focused cortical area.
| Study group | Role | What they receive |
|---|---|---|
| Effect of repeated TMS on aggressive impulse behavior in patients with BPD. | Experimental | A protocol of 15 sessions of repeated Transcranial Magnetic Stimulation at 1 Hz on right dorsolateral prefrontal cortex. Receives: Device: repeated transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maneuver effect
To determine whether the application of a series of 15 sessions of low-frequency (1 Hz) repeated Transcranial Magnetic Stimulation applied to the right dorsolateral prefrontal cortex reduces the severity of impulse agressive behavior in subjects with BPD as measured by the impulsive / premeditated aggression scale.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start21 Jan 2021
- Primary completion21 Jan 2021 (estimated)
- Study completion21 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JORGE GONZALEZ-OLVERA, PHD, Study chair, Instituto Nacional de Psiquiatría Ramon de la Fuente Muñiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722510
- Sponsor's protocol ID
- CEI/C/088/2016
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2021
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: In case of being requested
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repeated Transcranial Magnetic Stimulation on Aggressive Impulsive Behavior in Patients With Borderline Personality Disorder in a Social Exclusion Paradigm.
- ClinicalTrials.gov ID
- NCT04722510
- Acronym / sponsor ID
- CEI/C/088/2016
- Conditions
- Borderline Personality Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Instituto Nacional de Psiquiatría Dr. Ramón de la FuenteUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 21 Jan 2021 (estimated)
- Study completion
- 21 Jan 2021 (estimated)
- First posted
- 25 Jan 2021 (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.
Patients with a main diagnosis of borderline personality disorder will be recruited and will be randomized for the application of low frequency repeated transcranial magnetic stimulation (rTMS) protol or sham rTMS protocol. A pre-treatment and post-treatment measurement of the severity of BPD symptoms, impulsivity, and aggressive behavior will be carried out in all participants using self-administered questionnaires. All participants will be asked to participate in a passing ball game (Cyberball) with the intention of investigating aspects related to social inclusion / exclusion and measurements will be made regarding planning using the maze test. Participation in the Cyberball and the assessment of the planning will be carried out before and after the application of the treatment protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Effect of repeated TMS on aggressive impulse behavior in patients with BPD. | Experimental | Device: repeated transcranial magnetic stimulationA protocol of 15 sessions of repeated Transcranial Magnetic Stimulation at 1 Hz on right dorsolateral prefrontal cortex. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Outpatient consultant in the Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz.
- Main diagnosis of borderline personality disorder according to DSM-IV-TR.
- In the case of having some type of pharmacological treatment using SSRIs, antipsychotics and / or anticonvulsants, this should be maintained without modifications for at least 2 weeks prior to the start of the study and during the follow-up period.
- Comorbidity with some other personality disorder according to the SCID-II, with the exception of antisocial personality disorder.
- Acceptance of participation in the study by signing the informed consent.
Key exclusion criteria (6 listed)
- Subjects who did not agree to participate.
- Diagnosis of current antisocial personality disorder, bipolar disorder, psychotic disorders, severe major depressive episode, substance use disorder (except nicotine), and post-traumatic stress disorder.
- Presence of any comorbid neurological disorder.
- Diagnosis of intellectual disability.
- Subjects in whom the use of rTMS is contraindicated: history of seizures, pregnancy, presence of pacemaker, heart disease, and presence of a metallic object.
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 |
|---|---|---|
| repeated transcranial magnetic stimulationTranscranial magnetic stimulation is a non-invasive brain modulation technique that has proven to be a useful study and treatment tool in neuropsychiatric disorders. This technique allows to increase (with high frequency protocol, > 1 Hz) or decrease (with low frecuency protocols, 1 hz or less) neuronal excitability in a focused cortical area. | Device | Effect of repeated TMS on aggressive impulse behavior in patients with BPD. |
Primary outcome
Maneuver effect
Time frame: 3 weeks
To determine whether the application of a series of 15 sessions of low-frequency (1 Hz) repeated Transcranial Magnetic Stimulation applied to the right dorsolateral prefrontal cortex reduces the severity of impulse agressive behavior in subjects with BPD as measured by the impulsive / premeditated aggression scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Individual participant dataSharing planned: Undecided. In case of being requested
Related trials for Borderline Personality Disorder
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Not yet recruitingPhase 2
Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder
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Combining Transcranial Magnetic Stimulation With Emotion Regulation Skills Training in Borderline Personality Disorder
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Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder
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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. This study is not recruiting at the moment.
JORGE GONZALEZ-OLVERA, PHD study chair
Instituto Nacional de Psiquiatría Ramon de la Fuente Muñiz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repeated transcranial magnetic stimulation in people with Borderline Personality Disorder, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 1 site in Mexico.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 25 Jan 2021. 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 Mexico. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANDRES RODRIGUEZ-DELGADO, MD (525532250714, andres_rode@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maneuver effect (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2021.