Borderline Personality DisorderBorderStressNCT04852744
NEUROIMAGING OF ADOLESCENT BORDERLINE PERSONALITY DISORDER WITH AND WITHOUT POST-TRAUMATIC STRESS DISORDER
A study testing Brain MRI in people with Borderline Personality Disorder, run by University Hospital, Caen at 1 site in France.
Trial summary
Borderline personality disorder (BPD) is a common mental disorder in adolescents with significant individual and societal repercussions, characterized over the long term by emotional hyperresponsiveness, relational instability, identity disturbances and self-aggressive behavior. Read more about this study
- Who is it for?
- Ages 13 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Brain MRI
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2022to 1 Jun 2028
- 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 13 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- For the 3 groups:
- female
- Age between 13 and 17 years inclusive
- Oral and written comprehension of the French language
- Affiliation to the social security scheme
- Informed consent signed by the legal representatives holding the exercise of parental authority and the adolescent herself
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- For patients:
- Diagnosis of borderline personality disorder according to the criteria of the Diagnostic and Statistical Manual for mental disorders, fifth edition (DSM-5; American Psychiatric Association, 2013; SIDP-IV)
- Level of general psychopathology compatible with participation in the study (score> 20 on the CGA-S)
- TB + / PTSD + group:
- Post-traumatic stress disorder according to DSM-5 criteria (American Psychiatric Association, 2013; K-SADS-PL)
- In the control group :
- Absence of mental disorder according to DSM-5 criteria (American Psychiatric Association, 2013; K-SADS-PL and SIDP-IV)
- Oral and written comprehension of the French language
- Informed consent signed by the legal representative, the holder (s) of the exercise of parental authority and the adolescent herself
Who cannot join
- - Illiteracy / illiteracy
- Sensory disorder (visual, auditory)
- Severe chronic psychiatric comorbidity: autism spectrum disorder, intellectual disability, schizophrenia spectrum disorder and other psychotic disorders, bipolar disorder
- Severe or current brain pathology (chronic neurological disease, encephalitis, history of severe head trauma), alertness disorder
- History of anoxic coma
- Contraindication to MRI (magnetic foreign body, claustrophobia, contraindication to prolonged lying down)
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- Severe physical pathology in progress
- Moving outside the Normandy region planned within 18 months
- The inclusion of the subject in another biomedical research protocol (during the present study)
- Intellectual deficit (IQ <70)
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: NEUROIMAGERIE DU TROUBLE DE LA PERSONNALITE BORDERLINE A L'ADOLESCENCE AVEC ET SANS TROUBLE DE STRESS POST-TRAUMATIQUE
Borderline personality disorder (BPD) is a common mental disorder in adolescents with significant individual and societal repercussions, characterized over the long term by emotional hyperresponsiveness, relational instability, identity disturbances and self-aggressive behavior. The etiology of BPD is multifactorial and involves exposure to traumatic life events, which are present in the majority of cases. This explains the very common co-morbidity between BPD and post-traumatic stress disorder (PTSD), which involves emotionally painful memory relapses of one or more traumatic events, associated with an emotional trauma avoidance syndrome (s). ) and hypervigilance. Brain imaging studies in adolescents with BPD have shown decreases in the volume of gray matter within the frontolimbic network, as well as a decrease in frontolimbic white matter bundles. These brain changes are considered to be biological markers of TPB. However, the exact same brain changes are seen in PTSD. Although it represents more than a third of adolescents hospitalized in psychiatry, neuroscientific studies of BPD in adolescence are still scarce. The expertise we have acquired in U1077 in adolescents with PTSD offers us an exceptional opportunity to characterize in BPD with and without PTSD structural anomalies, including the hippocampus, and functional at rest, never used for hour in the teenager's BPD. Beyond that, carrying out an 18-month follow-up of the patients will allow us to assess the predictive value of these anomalies on the level of general psychopathology in all the patients studied and the intensity of the symptoms of traumatic relapse in the patients with PTSD. This modeling of disorders integrating psychopathological, neuropsychological and neuroanatomical approaches will provide the clinician with new knowledge necessary for therapeutic innovation.
Read the detailed description
A - RESEARCH OBJECTIVES
- Primary objective:
- Compare the hippocampal volume between adolescent girls with BPD with and without PTSD
- Secondary objectives:
- 1 - Evaluate the link, transverse and long-term (18 months), between the hippocampal volume and the level of general psychopathology in all the patients studied, and between the hippocampal volume and the intensity of the symptoms of traumatic revival in adolescent girls with PTSD.
- 2 - Compare the volume of the hippocampal subfields between adolescent girls with BPD with and without PTSD, and assess in patients with PTSD the link, transverse and long-term (18 months), between volumes of the hippocampal sub-fields and intensity symptoms of traumatic revival
- 3 - Compare the volume and integrity of the white matter bundles of the fronto-limbic network between adolescent girls with BPD with and without PTSD
- 4 - Compare resting brain activity between adolescent girls with BPD with and without PTSD
- 5 - Explore the links between changes in the brain and the intensity of the main psychological alterations associated with BPD in adolescence: i) attachment insecurity; ii) emotional dysregulation; iii) attention deficit and dysexecutive syndrome; iv) hypermentalization; and v) autobiographical memory and dissemination of identity.
B - Secondary evaluation criteria:
- 1 - Hippocampal volume (VBM); Global Clinical Assessment Scale score (CGA-S; Endicott et al., 1976); "Réviviscences" score in the French version of the UCLA Post-Traumatic Stress Disorder Reaction Index for Children and Adolescents (UCLA PTSD-RI C / A; Steinberg et al., 2013).
- 2 - Volume of each hippocampal subfield (Ammon's Horn [CA] 1, CA2, CA3, dentate gyrus, subiculum: anatomical MRI; Region Of Interest [ROI] method; Postel et al., 2019); "Intrusion" score of the French version of the UCLA PTSD-RI C / A.
- 3 - Orbitofrontal and cingulate cortex volume (VBM); anisotropy fraction (fractional anisotropy; FA) and average diffusivity (apparent diffusion coefficient; ADC) of fronto-limbic white matter beams (IRM Diffusion Tensor Imaging [DTI]; Le Bihan et al., 2001).
- 4 - Functional connectivity of brain networks in the resting state: default network (default mode network), salience network and central executive network; Viard et al., 2019).
- 5 - Brain modifications (VBM, ROI, AF, ADC, functional connectivity of resting networks) and: i) "Insecure attachment" score to Individual Relationship Model Cards (Ca-MIR; Pierrehumbert et al., 1996); ii) score "Separation-distress" and "Fear" in the French version of the Affective Neuroscience Personality Scale (ANPS; Pahlavan et al., 2008); iii) Continuous Performance Test omission score (CPT; Conners, 2002) and Wisconsin Card Sorting Test perseverance score (WCST; Heaton et al., 1993); iv) "Hypermentalisation" score in the French version of the Movie Assessment of Social Cognition (MASC; Martinez et al., 2017) and of the Reflective Functioning Questionnaire (RFQ; Badoud et al., 2015); and v) measurement of the quality of autobiographical productions (Reese et al., 2011), total score in the French version of the Assessment of Identity Development in Adolescence (AIDA; Goth et al., 2012).
- Conditions
- Borderline Personality Disorder
- Being tested
- Brain MRI
- Keywords
- Adolescence, Hippocampus, Neuropsychology, Borderline personality disorder, Post-traumatic stress disorder
- Medical subject headings
- Borderline Personality Disorder, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRIOther
Also called Psychological and behavioural assessment
Anatomical MRI The anatomical data will be acquired by means of a 3T Signa Premier General Electric Healthcare MRI, allowing the acquisition of classic anatomical sequences (T1, T2) and a high-resolution hippocampal sequence allowing to accurately apprehend its various sub-fields. (total acquisition time: 10 min).
The hippocampal volume, the orbital-frontal cortex and the cingulate cortex will be measured by voxel-based morphometry (VBM; Ashburner \& Friston, 2000]) using the SPM software (Statistical Parametric Mapping; Friston et al., 2006). The voxel-by-voxel morphometric analysis of T1 MRI images makes it possible to classify and segment the different brain tissues (gray matter versus white matter) and to analyze the focal differences in volume within these tissues between the different groups.
| Study group | Role | What they receive |
|---|---|---|
| Borderline girls with PTSD | Other | * female
* Age between 13 and 17 years inclusive
* Diagnosis of borderline personality disorder according to the criteria of the Diagnostic and Statistical Manual for mental disorders, fifth edition (DSM-5; American Psychiatric Association, 2013; SIDP-IV)
* Post-traumatic stress disorder according to DSM-5 criteria (American Psychiatric Association, 2013; K-SADS-PL)
* Level of general psychopathology compatible with participation in the study (score> 20 on the CGA-S)
* Oral and written comprehension of the French language
* Affiliation to the social security scheme
* Informed consent signed by the legal representatives holding the exercise of parental authority and the adolescent herself Receives: Other: Brain MRI |
| Borderline girls without PTSD | Other | * female
* Age between 13 and 17 years inclusive
* Diagnosis of borderline personality disorder according to the criteria of the Diagnostic and Statistical Manual for mental disorders, fifth edition (DSM-5; American Psychiatric Association, 2013; SIDP-IV)
* Level of general psychopathology compatible with participation in the study (score> 20 on the CGA-S)
* Oral and written comprehension of the French language
* Affiliation to the social security scheme
* Informed consent signed by the legal representatives holding the exercise of parental authority and the adolescent herself Receives: Other: Brain MRI |
| Healthy controls | Other | * female
* Age between 13 and 17 years inclusive
* Absence of mental disorder according to DSM-5 (American Psychiatric Association, 2013 ; K-SADS-PL et SIDP-IV)
* Oral and written comprehension of the French language
* Affiliation to the social security scheme
* Informed consent signed by the legal representatives holding the exercise of parental authority and the adolescent herself Receives: Other: Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hippocampal volume
Measured: during the month following inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start11 Mar 2022
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jun 2028 (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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- CHU de Rouen - Accueil, Centre Hospitalier Universitaire de Caen, Université de Caen Normandie, Centre Hospitalier du Rouvray, Institut National de la Santé Et de la Recherche Médicale, France, Groupe Hospitalier du Havre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852744
- Sponsor's protocol ID
- 2019-A00366-51
- Acronym
- BorderStress
- Status last verified
- Jul 2025
- First submitted
- 16 Apr 2021
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEUROIMAGERIE DU TROUBLE DE LA PERSONNALITE BORDERLINE A L'ADOLESCENCE AVEC ET SANS TROUBLE DE STRESS POST-TRAUMATIQUE
- ClinicalTrials.gov ID
- NCT04852744
- Acronym / sponsor ID
- BorderStress / 2019-A00366-51
- Conditions
- Borderline Personality Disorder
- Keywords
- Adolescence, Hippocampus, Neuropsychology, Borderline personality disorder, Post-traumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- CHU de Rouen - Accueil, Centre Hospitalier Universitaire de Caen, Université de Caen Normandie, Centre Hospitalier du Rouvray, Institut National de la Santé Et de la Recherche Médicale, France, Groupe Hospitalier du Havre
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 21 Apr 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.
Borderline personality disorder (BPD) is a common mental disorder in adolescents with significant individual and societal repercussions, characterized over the long term by emotional hyperresponsiveness, relational instability, identity disturbances and self-aggressive behavior. The etiology of BPD is multifactorial and involves exposure to traumatic life events, which are present in the majority of cases. This explains the very common co-morbidity between BPD and post-traumatic stress disorder (PTSD), which involves emotionally painful memory relapses of one or more traumatic events, associated with an emotional trauma avoidance syndrome (s). ) and hypervigilance. Brain imaging studies in adolescents with BPD have shown decreases in the volume of gray matter within the frontolimbic network, as well as a decrease in frontolimbic white matter bundles. These brain changes are considered to be biological markers of TPB. However, the exact same brain changes are seen in PTSD. Although it represents more than a third of adolescents hospitalized in psychiatry, neuroscientific studies of BPD in adolescence are still scarce. The expertise we have acquired in U1077 in adolescents with PTSD offers us an exceptional opportunity to characterize in BPD with and without PTSD structural anomalies, including the hippocampus, and functional at rest, never used for hour in the teenager's BPD. Beyond that, carrying out an 18-month follow-up of the patients will allow us to assess the predictive value of these anomalies on the level of general psychopathology in all the patients studied and the intensity of the symptoms of traumatic relapse in the patients with PTSD. This modeling of disorders integrating psychopathological, neuropsychological and neuroanatomical approaches will provide the clinician with new knowledge necessary for therapeutic innovation.
Detailed description
A - RESEARCH OBJECTIVES
- Primary objective:
- Compare the hippocampal volume between adolescent girls with BPD with and without PTSD
- Secondary objectives:
- 1 - Evaluate the link, transverse and long-term (18 months), between the hippocampal volume and the level of general psychopathology in all the patients studied, and between the hippocampal volume and the intensity of the symptoms of traumatic revival in adolescent girls with PTSD.
- 2 - Compare the volume of the hippocampal subfields between adolescent girls with BPD with and without PTSD, and assess in patients with PTSD the link, transverse and long-term (18 months), between volumes of the hippocampal sub-fields and intensity symptoms of traumatic revival
- 3 - Compare the volume and integrity of the white matter bundles of the fronto-limbic network between adolescent girls with BPD with and without PTSD
- 4 - Compare resting brain activity between adolescent girls with BPD with and without PTSD
- 5 - Explore the links between changes in the brain and the intensity of the main psychological alterations associated with BPD in adolescence: i) attachment insecurity; ii) emotional dysregulation; iii) attention deficit and dysexecutive syndrome; iv) hypermentalization; and v) autobiographical memory and dissemination of identity.
B - Secondary evaluation criteria:
- 1 - Hippocampal volume (VBM); Global Clinical Assessment Scale score (CGA-S; Endicott et al., 1976); "Réviviscences" score in the French version of the UCLA Post-Traumatic Stress Disorder Reaction Index for Children and Adolescents (UCLA PTSD-RI C / A; Steinberg et al., 2013).
- 2 - Volume of each hippocampal subfield (Ammon's Horn [CA] 1, CA2, CA3, dentate gyrus, subiculum: anatomical MRI; Region Of Interest [ROI] method; Postel et al., 2019); "Intrusion" score of the French version of the UCLA PTSD-RI C / A.
- 3 - Orbitofrontal and cingulate cortex volume (VBM); anisotropy fraction (fractional anisotropy; FA) and average diffusivity (apparent diffusion coefficient; ADC) of fronto-limbic white matter beams (IRM Diffusion Tensor Imaging [DTI]; Le Bihan et al., 2001).
- 4 - Functional connectivity of brain networks in the resting state: default network (default mode network), salience network and central executive network; Viard et al., 2019).
- 5 - Brain modifications (VBM, ROI, AF, ADC, functional connectivity of resting networks) and: i) "Insecure attachment" score to Individual Relationship Model Cards (Ca-MIR; Pierrehumbert et al., 1996); ii) score "Separation-distress" and "Fear" in the French version of the Affective Neuroscience Personality Scale (ANPS; Pahlavan et al., 2008); iii) Continuous Performance Test omission score (CPT; Conners, 2002) and Wisconsin Card Sorting Test perseverance score (WCST; Heaton et al., 1993); iv) "Hypermentalisation" score in the French version of the Movie Assessment of Social Cognition (MASC; Martinez et al., 2017) and of the Reflective Functioning Questionnaire (RFQ; Badoud et al., 2015); and v) measurement of the quality of autobiographical productions (Reese et al., 2011), total score in the French version of the Assessment of Identity Development in Adolescence (AIDA; Goth et al., 2012).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Borderline girls with PTSD | Other | Other: Brain MRI* female * Age between 13 and 17 years inclusive * Diagnosis of borderline personality disorder according to the criteria of the Diagnostic and Statistical Manual for mental disorders, fifth edition (DSM-5; American Psychiatric Association, 2013; SIDP-IV) * Post-traumatic stress disorder according to DSM-5 criteria (American Psychiatric Association, 2013; K-SADS-PL) * Level of general psychopathology compatible with participation in the study (score> 20 on the CGA-S) * Oral and written comprehension of the French language * Affiliation to the social security scheme * Informed consent signed by the legal representatives holding the exercise of parental authority and the adolescent herself |
| Borderline girls without PTSD | Other | Other: Brain MRI* female * Age between 13 and 17 years inclusive * Diagnosis of borderline personality disorder according to the criteria of the Diagnostic and Statistical Manual for mental disorders, fifth edition (DSM-5; American Psychiatric Association, 2013; SIDP-IV) * Level of general psychopathology compatible with participation in the study (score> 20 on the CGA-S) * Oral and written comprehension of the French language * Affiliation to the social security scheme * Informed consent signed by the legal representatives holding the exercise of parental authority and the adolescent herself |
| Healthy controls | Other | Other: Brain MRI* female * Age between 13 and 17 years inclusive * Absence of mental disorder according to DSM-5 (American Psychiatric Association, 2013 ; K-SADS-PL et SIDP-IV) * Oral and written comprehension of the French language * Affiliation to the social security scheme * Informed consent signed by the legal representatives holding the exercise of parental authority and the adolescent herself |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- female
- Age between 13 and 17 years inclusive
- Oral and written comprehension of the French language
- Affiliation to the social security scheme
- Informed consent signed by the legal representatives holding the exercise of parental authority and the adolescent herself
Key exclusion criteria (11 listed)
- - Illiteracy / illiteracy
- Sensory disorder (visual, auditory)
- Severe chronic psychiatric comorbidity: autism spectrum disorder, intellectual disability, schizophrenia spectrum disorder and other psychotic disorders, bipolar disorder
- Severe or current brain pathology (chronic neurological disease, encephalitis, history of severe head trauma), alertness disorder
- History of anoxic coma
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 |
|---|---|---|
| Brain MRIAlso: Psychological and behavioural assessmentAnatomical MRI The anatomical data will be acquired by means of a 3T Signa Premier General Electric Healthcare MRI, allowing the acquisition of classic anatomical sequences (T1, T2) and a high-resolution hippocampal sequence allowing to accurately apprehend its various sub-fields. (total acquisition time: 10 min). The hippocampal volume, the orbital-frontal cortex and the cingulate cortex will be measured by voxel-based morphometry (VBM; Ashburner \& Friston, 2000]) using the SPM software (Statistical Parametric Mapping; Friston et al., 2006). The voxel-by-voxel morphometric analysis of T1 MRI images makes it possible to classify and segment the different brain tissues (gray matter versus white matter) and to analyze the focal differences in volume within these tissues between the different groups. | Other | Borderline girls with PTSD, Borderline girls without PTSD, Healthy controls |
Primary outcome
Hippocampal volume
Time frame: during the month following inclusion
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 25 Jul 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain MRI in people with Borderline Personality Disorder, run by University Hospital, Caen at 1 site in France.
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 15 inclusion and 11 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 25 Jul 2025. 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 France. 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?
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 Fabian Guénolé, Pr. (+33 (0) 231 272 309, guenole-f@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hippocampal volume (time frame: during the month following inclusion). 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 Jul 2025; AzTrials last refreshed its copy on 26 Oct 2026.