Adolescent BehaviorEEG-NIRSNCT03139825
Connectivity and Social Cognition in Adolescent Girls With Borderline Personality Disorder, a Pilot Study
A study testing Exploring the feasibility of learning during cognitive tasks (EEG-NIRS) in people with Adolescent Behavior and Borderline Personality Disorder, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The disruption of social cognition associated with borderline personality disorder (BPD), and more specifically categorization of facial emotions, remains largely under-studied, despite the high frequency of this pathology in the clinical population. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Adolescent Behavior, Borderline Personality Disorder
- What is being tested?
- Exploring the feasibility of learning during cognitive tasks (EEG-NIRS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2017to 12 Mar 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 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescents 14-17 years of age with suicidal behavior and a borderline personality disorder for whom consent is obtained from parental authority,
- Affiliation to Social Security
Who cannot join
- Intellectual disability, psychopathy, delusional or concomitant major depression
Trial locations and contacts
1 site in 1 country.
About this study
The disruption of social cognition associated with borderline personality disorder (BPD), and more specifically categorization of facial emotions, remains largely under-studied, despite the high frequency of this pathology in the clinical population. The first results differ from the observations made in adults and this confirms the relevance of studying this theme specifically in adolescence. On the cognitive level, there is a disturbance of the detection and the categorization of the facial emotions in the TPL. The characteristics of this disturbance and its possible association with an attack on the connectivity of the brain remain unknown in adolescence. No functional imaging studies are published in adolescent TPL. This pilot bimodal functional imaging study EEG-NIRS aims to collect preliminary and feasibility data to support a response to upcoming PHRC competitions and eventually offer a science thesis opportunity.
- Being tested
- Exploring the feasibility of learning during cognitive tasks (EEG-NIRS)
- Medical subject headings
- Adolescent Behavior, Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exploring the feasibility of learning during cognitive tasks (EEG-NIRS)Other
Exploring the feasibility of the study in its aspects of recruitment and tolerability of tasks and acquisition of electrical and hemodynamic data that can be used during cognitive tasks
| Study group | Role | What they receive |
|---|---|---|
| Adolescent with suicidal behavior and personality disorder | Other | Not described Receives: Other: Exploring the feasibility of learning during cognitive tasks (EEG-NIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis by functional imaging study of the characteristics of disorders of personalities and its possible association with an attack on connectivity of the brain
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start22 Feb 2017
- Primary completion22 Feb 2018 (estimated)
- Study completion12 Mar 2019
Why it stopped: Not accepted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139825
- Sponsor's protocol ID
- PI2019_843_0026
- Acronym
- EEG-NIRS
- Status last verified
- Jun 2023
- First submitted
- 28 Apr 2017
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connectivity and Social Cognition in Adolescent Girls With Borderline Personality Disorder, a Pilot Study
- ClinicalTrials.gov ID
- NCT03139825
- Acronym / sponsor ID
- EEG-NIRS / PI2019_843_0026
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not accepted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 22 Feb 2018 (estimated)
- Study completion
- 12 Mar 2019 (actual)
- First posted
- 4 May 2017 (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 disruption of social cognition associated with borderline personality disorder (BPD), and more specifically categorization of facial emotions, remains largely under-studied, despite the high frequency of this pathology in the clinical population. The first results differ from the observations made in adults and this confirms the relevance of studying this theme specifically in adolescence. On the cognitive level, there is a disturbance of the detection and the categorization of the facial emotions in the TPL. The characteristics of this disturbance and its possible association with an attack on the connectivity of the brain remain unknown in adolescence. No functional imaging studies are published in adolescent TPL. This pilot bimodal functional imaging study EEG-NIRS aims to collect preliminary and feasibility data to support a response to upcoming PHRC competitions and eventually offer a science thesis opportunity.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescent with suicidal behavior and personality disorder | Other | Other: Exploring the feasibility of learning during cognitive tasks (EEG-NIRS) |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Adolescents 14-17 years of age with suicidal behavior and a borderline personality disorder for whom consent is obtained from parental authority,
- Affiliation to Social Security
Key exclusion criteria (1 listed)
- Intellectual disability, psychopathy, delusional or concomitant major depression
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 |
|---|---|---|
| Exploring the feasibility of learning during cognitive tasks (EEG-NIRS)Exploring the feasibility of the study in its aspects of recruitment and tolerability of tasks and acquisition of electrical and hemodynamic data that can be used during cognitive tasks | Other | Adolescent with suicidal behavior and personality disorder |
Primary outcome
Analysis by functional imaging study of the characteristics of disorders of personalities and its possible association with an attack on connectivity of the brain
Time frame: 3 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exploring the feasibility of learning during cognitive tasks (EEG-NIRS) in people with Adolescent Behavior and Borderline Personality Disorder, run by Centre Hospitalier Universitaire, Amiens 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 22 Jun 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis by functional imaging study of the characteristics of disorders of personalities and its possible association with an attack on connectivity of the brain (time frame: 3 hours). 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 22 Jun 2023.