Amotivational Syndrome and Fatigue in Neurosurgery

Fatigue Clinical Trial

— DENI-CARE  

Official title:

Amotivational Syndrome and Fatigue in Neurosurgery: The Impact of Neuroinflammation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04907513
• Other study ID #: PBN_2021_1
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Brain Injuries
• Cerebral Injury
• Fatigue
• Motivation

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