Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04852744 |
| Other study ID # |
2019-A00366-51 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
June 1, 2024 |
Study information
| Verified date |
April 2021 |
| Source |
University Hospital, Caen |
| Contact |
Fabian Guénolé, Pr. |
| Phone |
+33 (0) 231 272 309 |
| Email |
guenole-f[@]chu-caen.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
Description:
A - RESEARCH OBJECTIVES
1. Primary objective:
• Compare the hippocampal volume between adolescent girls with BPD with and without PTSD
2. 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).
