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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04907513
Other study ID # PBN_2021_1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 4, 2021
Est. completion date December 1, 2024

Study information

Verified date February 2023
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact Pierre Bourdillon, MD, PhD
Phone (0)148036862
Email pbourdillon@for.paris
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Depression is a major public concern associated with profound distress, intense suffering, and impairment in social, professional and familial functioning. Among the numerous symptoms defining depression, fatigue and motivation are not only frequent but also highly associated with poor quality of life and resistance to conventional antidepressant. Recent data, mainly obtained in animals, suggest that these symptoms may be linked to inflammatory processes within the central nervous system. Yet access to the brain is too invasive for exploring this link in patients with psychiatric conditions. However, certain conditions in neurosurgery, such as aneurysm rupture, require external evacuation, over several days or weeks, of the fluid bathing the brain through a catheter directly inserted into it. Critically, these patients also exhibit extreme exhaustion and fluctuating motivation, allowing to investigate the involvement of neuroinflammation in lack of motivation and fatigue by carrying out repeated motivation assessments with short behavioral tests (around ten minutes), while performing an analysis of inflammation markers in the fluid evacuated from the brain. The identification of inflammatory mechanisms underlying lack of motivation and fatigue could lead to the development of treatments for both resistant depression and motivation deficits that largely hamper rehabilitation in neurosurgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date December 1, 2024
Est. primary completion date December 4, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria: - Age >= 18 years old - Patients required an external cerebrospinal fluid drainage Exclusion Criteria: - Pregnant or breast feeding patient - Patient under legal protection - Patient opposition to participate in this study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Assessment of the Motivational State
A motivational interviewing algorithm developed in Rothschild Hospital for this study will be used. The results range between 0% (worst motivational state) to 100% (best motivational state).

Locations

Country Name City State
France Hôpital Fondation Adolphe de Rothschild Paris Ile-de-France

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nerotransmitter levels in cerebrospinal fuid in relation to patient motivational condition Study the correlation between serotonin, dopamin and glutamate concentrations in the cerebrospinal fluid with the motivational state of the patients 36 months
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