Amotivational Syndrome and Fatigue in Neurosurgery

NCT04907513 | Unknown

• 1 other identifier: PBN_2021_1
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Injury; Motivation; Fatigue

Keywords

cerebrospinal fluid

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Amotivational Syndrome

Patients required an external drainage of the cerebrospinal fluid.

Other: Assessment of the Motivational State

Interventions

Assessment of the Motivational State OTHER

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).

Amotivational Syndrome

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients required an external drainage of the cerebrospinal fluid

You may qualify if:

• Age \>= 18 years old
• Patients required an external cerebrospinal fluid drainage

You may not qualify if:

• Pregnant or breast feeding patient
• Patient under legal protection
• Patient opposition to participate in this study

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hôpital Fondation Adolphe de Rothschild

Paris, Île-de-France Region, 75019, France

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Fatigue

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pierre Bourdillon, MD, PhD

CONTACT

(0)148036862; pbourdillon@for.paris

Amélie Yavchitz, MD,PhD

CONTACT

(0)148036454; ayavchitz@for.paris

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: December 4, 2021
• Primary Completion: December 4, 2023
• Study Completion: December 1, 2024
• Last Updated: February 17, 2023

Record last verified: 2023-02

Locations

FR (1)