Borderline Personality DisorderTMS&BPDNCT03832777
Transcranial Magnetic Stimulation on Dorsomedial Prefrontal Cortex in Borderline Personality Disorder
A study testing Repetitive Transcranial Magnetic Stimulation in people with Borderline Personality Disorder, run by Universidad Autonoma de Queretaro at 1 site in Mexico.
Trial summary
This study evaluates the effect of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) on Dorsomedial Prefrontal Cortex on Borderline Personality Disorder (BPD). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 5 Mar 2018to 30 Aug 2019
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-45 years old.
- Meet DSM 5 (Diagnostic and Statistical Manual, 5th edition) diagnostic criteria for Borderline Personality Disorder.
- Score of >7 in the Diagnostic Interview for Borderline (Revised version, DIB-R)
- All patients must have follow-up psychotherapy of at least one month.
- No changes on pharmacological treatment within the last month.
- Patients must provide their oral and written informed consent.
Who cannot join
- Subjects with history of traumatic brain injury with loss of consciousness.
- Subjects with intracranial metallic objects or metal plates in the skull.
- Subjects diagnosed with uncontrolled chronic (for example: hypertension, diabetes) or neurological diseases.
- Comorbidity with other mental illness. (Except Depressive symptoms and Anxiety Disorders).
- Presence of psychotic symptoms.
- Alterations in the electroencephalogram (epileptiform activity).
- Self injury or suicidal attempts in less than 2 weeks (depends on the severity and deepness).
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Autonomous University of Queretaro
Querétaro City, Querétaro, 76176
Angel R Calderón-Moctezuma, Physician, +529511047213, angel_roman_cm@hotmail.com
About this study
Official title: Effect of Transcranial Magnetic Stimulation on Dorsomedial Cortex in Clinical and Neuropsychological Variables in Borderline Personality Disorder
This study evaluates the effect of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) on Dorsomedial Prefrontal Cortex on Borderline Personality Disorder (BPD).
Read the detailed description
Borderline Personality Disorder (BPD) is a mental illness with a high worldwide prevalence and economic costs, and is characterized with impulsiveness, both interpersonal relationships and emotional disturbance. Symptoms are related to hypofunction of frontal areas like Dorsomedial Prefrontal Cortex (DMPFC). Psychotherapy is the base treatment in this disease, but economic costs and long-time therapy have made difficult the attachment. Repetitive Transcranial Magnetic Stimulation(rTMS), authorized by Food and Drug Administration (FDA) on Major Depressive Disorder (MDD) treatment has proven good results in previous works in BPD clinical characteristics on both dorsolateral prefrontal cortex (DLPFC) and enhancement in depressive symptoms stimulating DMPFC in high frequency. However, there are no current research that have addressed the use of low-frequency on this anatomical area.
- Conditions
- Borderline Personality Disorder
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- Borderline Personality Disorder, Personality Disorders
- Medical subject headings
- Borderline Personality Disorder, Personality Disorders
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 Transcranial Magnetic Stimulation
Subjects will receive both active and placebo rTMS, in a crossover modality.
| Study group | Role | What they receive |
|---|---|---|
| 5 Hz Stimulation | Active comparator | This group will receive 5Hz (Hertz) Dorsomedial Prefrontal Cortex repetitive Transcranial Magnetic Stimulation with 1500 pulses per session, once per weekday, with a final result of 15 sessions in this modality. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| Placebo Stimulation | Placebo comparator | This group will receive the Sham modality simulating 1500 pulses of 5Hz Transcranial Magnetic Stimulation for 15 sessions, one per weekday. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Borderline Symptoms List (BSL)
BSL is a 23 item scale that evaluates the general symptoms and 11 items with behavioural evaluation of BPD.
Measured: 6 weeks
Global Clinical Impression of BPD (GCI-BPD)
CGI-BPD is a 10 item evaluation that rates the severity of BPD distributed in 9 neuropsychological domains with a final global score.
Measured: 6 weeks
Borderline Evaluation of Severity Over Time (BEST)
BEST is a 15 item scale that evaluates the severity in this pathology according to 3 areas: thoughts, emotions and typical behaviours.
Measured: 6 weeks
Secondary outcomes (3)
Hamilton Depression Rating Scale (HDRS)
HDRS is a 21 item scale that evaluates the severity of depressive symptoms in patients.
Measured: 6 weeks
Hamilton Anxiety Rating Scale (HARS)
HARS is a 14 items rating scale that evaluates the severity of anxiety symptoms in patients.
Measured: 6 weeks
Barratt Impulsivity Scale (BIS-11)
The Barratt Impulsiveness Scale is a questionnaire designed to assess the personality / behavioral construct of impulsiveness; composed of 30 items describing common impulsive or non-impulsive (for reversed scored items) behaviors and preferences .
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start5 Mar 2018
- Primary completion30 Jan 2019
- Study completion30 Aug 2019 (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 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
- Randomised
- Intervention model
- Crossover
- Model description
- The aim of this study is to evaluate the clinical effects of 5Hz rTMS over Dorsomedial Prefrontal Cortex on an active versus placebo modality stimulation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Queretaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Julian Reyes López, Universidad Autonoma de Queretaro
- Investigators
- Julian V Reyes-López, Psychiatrist, Study director, Faculty of Medicine, Autonomous University of Queretaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832777
- Sponsor's protocol ID
- 04-01/02/2018
- Acronym
- TMS&BPD
- Status last verified
- Jan 2019
- First submitted
- 5 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Calderon-Moctezuma AR, Reyes-Lopez JV, Rodriguez-Valdes R, Barbosa-Luna M, Ricardo-Garcell J, Espino-Cortes M, Hernandez-Chan N, Garcia-Noguez L, Roque-Roque G, Trejo-Cruz G, Canizares-Gomez S, Hernandez-Montiel H. Improvement in borderline personality disorder symptomatology after repetitive transcranial magnetic stimulation of the dorsomedial prefrontal cortex: preliminary results. Braz J Psychiatry. 2021 Feb 1;43(1):65-69. doi: 10.1590/1516-4446-2019-0591. eCollection 2020.
PubMed 32876128
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Magnetic Stimulation on Dorsomedial Cortex in Clinical and Neuropsychological Variables in Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT03832777
- Acronym / sponsor ID
- TMS&BPD / 04-01/02/2018
- Conditions
- Borderline Personality Disorder
- Keywords
- Borderline Personality Disorder, Personality Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidad Autonoma de QueretaroUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 6 Feb 2019 (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.
This study evaluates the effect of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) on Dorsomedial Prefrontal Cortex on Borderline Personality Disorder (BPD).
Detailed description
Borderline Personality Disorder (BPD) is a mental illness with a high worldwide prevalence and economic costs, and is characterized with impulsiveness, both interpersonal relationships and emotional disturbance. Symptoms are related to hypofunction of frontal areas like Dorsomedial Prefrontal Cortex (DMPFC). Psychotherapy is the base treatment in this disease, but economic costs and long-time therapy have made difficult the attachment. Repetitive Transcranial Magnetic Stimulation(rTMS), authorized by Food and Drug Administration (FDA) on Major Depressive Disorder (MDD) treatment has proven good results in previous works in BPD clinical characteristics on both dorsolateral prefrontal cortex (DLPFC) and enhancement in depressive symptoms stimulating DMPFC in high frequency. However, there are no current research that have addressed the use of low-frequency on this anatomical area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The aim of this study is to evaluate the clinical effects of 5Hz rTMS over Dorsomedial Prefrontal Cortex on an active versus placebo modality stimulation.
| Arm | Type | Receives |
|---|---|---|
| 5 Hz Stimulation | Active comparator | Device: Repetitive Transcranial Magnetic StimulationThis group will receive 5Hz (Hertz) Dorsomedial Prefrontal Cortex repetitive Transcranial Magnetic Stimulation with 1500 pulses per session, once per weekday, with a final result of 15 sessions in this modality. |
| Placebo Stimulation | Placebo comparator | Device: Repetitive Transcranial Magnetic StimulationThis group will receive the Sham modality simulating 1500 pulses of 5Hz Transcranial Magnetic Stimulation for 15 sessions, one per weekday. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-45 years old.
- Meet DSM 5 (Diagnostic and Statistical Manual, 5th edition) diagnostic criteria for Borderline Personality Disorder.
- Score of >7 in the Diagnostic Interview for Borderline (Revised version, DIB-R)
- All patients must have follow-up psychotherapy of at least one month.
- No changes on pharmacological treatment within the last month.
Key exclusion criteria (7 listed)
- Subjects with history of traumatic brain injury with loss of consciousness.
- Subjects with intracranial metallic objects or metal plates in the skull.
- Subjects diagnosed with uncontrolled chronic (for example: hypertension, diabetes) or neurological diseases.
- Comorbidity with other mental illness. (Except Depressive symptoms and Anxiety Disorders).
- Presence of psychotic symptoms.
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: Transcranial Magnetic StimulationSubjects will receive both active and placebo rTMS, in a crossover modality. | Device | 5 Hz Stimulation, Placebo Stimulation |
Primary outcome
Borderline Symptoms List (BSL)
Time frame: 6 weeks
BSL is a 23 item scale that evaluates the general symptoms and 11 items with behavioural evaluation of BPD.
Global Clinical Impression of BPD (GCI-BPD)
Time frame: 6 weeks
CGI-BPD is a 10 item evaluation that rates the severity of BPD distributed in 9 neuropsychological domains with a final global score.
Borderline Evaluation of Severity Over Time (BEST)
Time frame: 6 weeks
BEST is a 15 item scale that evaluates the severity in this pathology according to 3 areas: thoughts, emotions and typical behaviours.
3 secondary outcomes
Hamilton Depression Rating Scale (HDRS)
Time frame: 6 weeks
Hamilton Anxiety Rating Scale (HARS)
Time frame: 6 weeks
Barratt Impulsivity Scale (BIS-11)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 32876128Calderon-Moctezuma AR, Reyes-Lopez JV, Rodriguez-Valdes R, Barbosa-Luna M, Ricardo-Garcell J, Espino-Cortes M, Hernandez-Chan N, Garcia-Noguez L, Roque-Roque G, Trejo-Cruz G, Canizares-Gomez S, Hernandez-Montiel H. Improvement in borderline personality disorder symptomatology after repetitive transcranial magnetic stimulation of the dorsomedial prefrontal cortex: preliminary results. Braz J Psychiatry. 2021 Feb 1;43(1):65-69. doi: 10.1590/1516-4446-2019-0591. eCollection 2020.
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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.
Julian V Reyes-López, Psychiatrist study director
Faculty of Medicine, Autonomous University of Queretaro
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 in people with Borderline Personality Disorder, run by Universidad Autonoma de Queretaro 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 6 inclusion and 7 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 15 Feb 2019. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angel R Calderón-Moctezuma, Physician (+52 9511047213, angel_roman_cm@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Borderline Symptoms List (BSL) (time frame: 6 weeks). The study lists 3 primary outcomes in all. 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 NCT03832777, 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 15 Feb 2019.