Amotivational Syndrome and Fatigue in Neurosurgery (DENI-CARE)

Amotivational Syndrome and Fatigue in Neurosurgery: The Impact of Neuroinflammation

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.

Study Overview

• Status: Recruiting
• Conditions: Fatigue; Motivation; Cerebral Injury
• Intervention / Treatment: Other: Assessment of the Motivational State

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

• Study Contact: Name: Pierre Bourdillon, MD, PhD; Phone Number: +33 (0)148036862; Email: pbourdillon@for.paris
• Study Contact Backup: Name: Amélie Yavchitz, MD,PhD; Phone Number: (0)148036454; Email: ayavchitz@for.paris

Study Locations

• France
  • Ile-de-France
    • Paris, Ile-de-France, France, 75019
      • Recruiting
      • Hôpital Fondation Adolphe de Rothschild
      • Contact: Pierre Bourdillon, MD, PhD; Phone Number: +33 (0)148036862; Email: pbourdillon@for.paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients required an external drainage of the cerebrospinal fluid

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2021
• Primary Completion (Anticipated): December 4, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: cerebrospinal fluid
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Fatigue; Brain Injuries
• Other Study ID Numbers: PBN_2021_1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No