DENI-CARE: Amotivational Syndrome and Fatigue in Neurosurgery

Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Recruiting
CT.gov ID
NCT04907513
Collaborator
(none)
25
1
35.9
0.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Assessment of the Motivational State

Study Design

Study Type:
Observational
Anticipated Enrollment :
25 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Amotivational Syndrome and Fatigue in Neurosurgery: The Impact of Neuroinflammation
Actual Study Start Date :
Dec 4, 2021
Anticipated Primary Completion Date :
Dec 4, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Amotivational Syndrome

Patients required an external drainage of the cerebrospinal fluid.

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).

Outcome Measures

Primary Outcome Measures

  1. Nerotransmitter levels in cerebrospinal fuid in relation to patient motivational condition [36 months]

    Study the correlation between serotonin, dopamin and glutamate concentrations in the cerebrospinal fluid with the motivational state of the patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Fondation Adolphe de Rothschild Paris Ile-de-France France 75019

Sponsors and Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT04907513
Other Study ID Numbers:
  • PBN_2021_1
First Posted:
May 28, 2021
Last Update Posted:
Feb 8, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2022