Ageing and Geriatric HealthGENEUS 1NCT07506941
Study of Functional Decline and Care Pathways in Neurosurgical Patients Over 65 Years of Age
An observational study of Ageing and Geriatric Health, run by University Hospital, Toulouse at 6 sites in 3 countries.
Trial summary
The GENEUS 1 study addresses this gap by characterizing the real-world profiles, outcomes, and care pathways of adults aged 65 years and older hospitalized in neurosurgery across France, Spain, and Portugal. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Ageing and Geriatric Health
- How many people
- 209 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 1 Apr 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 65 years or older admitted for neurosurgical intervention, for whom follow-up for 3 months is possible given their cognitive status and life expectancy, and who agrees to the retrieval of their hospital clinical and health economic data during the year following their discharge from the hospital
Who may be able to join
- Age ≥ 65 years at the time of admission Admission to a neurosurgery department in one of the participating centres (France, Spain, or Portugal), Affiliation with a national health-insurance or equivalent system Feasibility of follow-up at 3 months, Consent/non-opposition for the study
Who cannot join
- Terminal illness (neurosurgical or not) with an estimated life expectancy of < 3 months.
- Loss of autonomy prior to admission, established as ADL < 3. For a patient admitted to the emergency hospital, ask him (or his caregiver) about his functional abilities before his condition deteriorated.
- Legal protection status (guardianship, trusteeship, or judicial protection) when such status prevents lawful consent or non-opposition.
- Participation in another interventional clinical study whose procedures or follow-up could interfere with GENEUS 1 objectives or endpoints.
- Severe cognitive or communication impairment
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Veronique CHAIGNEAU contact
6 sites in 3 countries
Spain3 sites
Hospital General Universitario Alicante
Alicante
Pablo González-López
Complexo Hospitalario De Ourense
Ourense
Ana PASTOR
Navarrabiomed
Pamplona
Idoya Zazpe Cenoz
Portugal2 sites
CUF Descobertas
Lisbon
Ricardo Malcata Nogueira
ULS Santa Maria
Lisbon
Diogo Roque
About this study
Official title: A Prospective, Multicenter, and Transnational Study of Functional Decline and Care Pathways in Neurosurgical Patients Over 65 Years of Age
The GENEUS 1 study addresses this gap by characterizing the real-world profiles, outcomes, and care pathways of adults aged 65 years and older hospitalized in neurosurgery across France, Spain, and Portugal. This project represents the first multicentre, transnational initiative to integrate geriatric principles into neurosurgical practice and to evaluate both clinical and economic outcomes in this population.
Read the detailed description
This is a prospective, multicentre, multinational, observational study.
Seven neurosurgical centres in France, Spain, and Portugal will participate. Each participant will be followed at three timepoints:
V0 (Admission): baseline clinical and geriatric assessment. V1 (Discharge): length of stay, complications, and updated functional and cognitive status.
V2 (3 months ±1 week): structured telephone follow-up or face-to-face visit to assess readmission, autonomy, and quality of life.
A 12-month medico-economic component (only in France) will evaluate healthcare utilization and costs using clinical data, patient or caregiver questionnaires, and linkage with the Système National des Données de Santé (SNDS) in France.
- Conditions
- Ageing and Geriatric Health
- Keywords
- neurosurgery, geriatric medicine
What is being measured
The primary outcome is the main question the study is designed to answer.
The evolution of functional autonomy between baseline and 3 months post-discharge
The change is measured using validated geriatric scale Basic Activities of Daily Living Functional decline will be defined as any clinically significant decrease in ADL score compared with baseline. The change will be expressed both as a continuous variable (score variation) and as a categorical outcome (improved / stable / declined autonomy).
This criterion captures the short-term functional trajectory of older adults after a neurosurgical hospitalization and serves as the main indicator of care effectiveness and adaptation to geriatric needs.
Measured: between baseline and 3-month after discharge
Secondary outcomes (8)
Length of hospital stay
Number of days from admission to discharge.
Measured: baseline until the day of hospital discharge
Postoperative complications
Complications classified according to the Clavien-Dindo scale
Measured: the day of the hospital discharge
Daily living
scoring of the scale : instrumental activities of daily living (IADL) score 0 is the worst, score 8 is the best autonomy
Measured: baseline, the day of hospital discharge and 3-month after discharge
Composite criteria of Cognitive status and delirium composed of 3 criteriaes
first criteria : score of the scale of Sclan and Reisberg - score is between 1 and 7 - 1 is the better and 7 the worst second criteria : score of the test for delirium \& cognitive impairment (4AT) - the score is beetwen 0 and 4 - 0 is the better and 4 the worst third criteria : Mini Mental State Examination
Measured: baseline and the day of hospital discharge
Psychological status
Scoring of the Patient Health Questionnaire (GDS4) - score is 0 to 4 - 0 is not depressed - 4 is very depressed
Measured: baseline and 3month after discharge
Frailtry
scoring of CFS (clinical Frailty scale) - score from 1 to 9 (scores of 1-3 are considered non-frail, 4 to be pre-frail, 5-8 as frail and 9 as terminally ill)
Measured: baseline, day of hospital discharge and 3 month after discharge
Quality of life score
Scoring of the EQ-5D-5L questionnaire (score from 0 to 100 - 0 is better and 100 is the worst)
Measured: baseline, day of hospital discharge, and 3 months after discharge
Composite criteria composed of two criteriaes : functional recovery and autonomy evolution
Scoring of Activities of Daily Living (ADL) : score 0 to 6 : score of 0 is the worst and score 6 is the best and instrumental activities of daily living (IADL scale) score 0 is the worst, score 8 is the best autonomy
Measured: 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ageing and Geriatric HealthStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 209 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric SCHMIDT, Study director, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506941
- Sponsor's protocol ID
- RC31/25/0220
- Acronym
- GENEUS 1
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, and Transnational Study of Functional Decline and Care Pathways in Neurosurgical Patients Over 65 Years of Age
- ClinicalTrials.gov ID
- NCT07506941
- Acronym / sponsor ID
- GENEUS 1 / RC31/25/0220
- Conditions
- Ageing and Geriatric Health
- Keywords
- neurosurgery, geriatric medicine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 209 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The GENEUS 1 study addresses this gap by characterizing the real-world profiles, outcomes, and care pathways of adults aged 65 years and older hospitalized in neurosurgery across France, Spain, and Portugal. This project represents the first multicentre, transnational initiative to integrate geriatric principles into neurosurgical practice and to evaluate both clinical and economic outcomes in this population.
Detailed description
This is a prospective, multicentre, multinational, observational study.
Seven neurosurgical centres in France, Spain, and Portugal will participate. Each participant will be followed at three timepoints:
V0 (Admission): baseline clinical and geriatric assessment. V1 (Discharge): length of stay, complications, and updated functional and cognitive status.
V2 (3 months ±1 week): structured telephone follow-up or face-to-face visit to assess readmission, autonomy, and quality of life.
A 12-month medico-economic component (only in France) will evaluate healthcare utilization and costs using clinical data, patient or caregiver questionnaires, and linkage with the Système National des Données de Santé (SNDS) in France.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 years or older admitted for neurosurgical intervention, for whom follow-up for 3 months is possible given their cognitive status and life expectancy, and who agrees to the retrieval of their hospital clinical and health economic data during the year following their discharge from the hospital
Key inclusion criteria (1 listed)
- Age ≥ 65 years at the time of admission Admission to a neurosurgery department in one of the participating centres (France, Spain, or Portugal), Affiliation with a national health-insurance or equivalent system Feasibility of follow-up at 3 months, Consent/non-opposition for the study
Key exclusion criteria (5 listed)
- Terminal illness (neurosurgical or not) with an estimated life expectancy of < 3 months.
- Loss of autonomy prior to admission, established as ADL < 3. For a patient admitted to the emergency hospital, ask him (or his caregiver) about his functional abilities before his condition deteriorated.
- Legal protection status (guardianship, trusteeship, or judicial protection) when such status prevents lawful consent or non-opposition.
- Participation in another interventional clinical study whose procedures or follow-up could interfere with GENEUS 1 objectives or endpoints.
- Severe cognitive or communication impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The evolution of functional autonomy between baseline and 3 months post-discharge
Time frame: between baseline and 3-month after discharge
The change is measured using validated geriatric scale Basic Activities of Daily Living Functional decline will be defined as any clinically significant decrease in ADL score compared with baseline. The change will be expressed both as a continuous variable (score variation) and as a categorical outcome (improved / stable / declined autonomy). This criterion captures the short-term functional trajectory of older adults after a neurosurgical hospitalization and serves as the main indicator of care effectiveness and adaptation to geriatric needs.
8 secondary outcomes
Length of hospital stay
Time frame: baseline until the day of hospital discharge
Postoperative complications
Time frame: the day of the hospital discharge
Daily living
Time frame: baseline, the day of hospital discharge and 3-month after discharge
Composite criteria of Cognitive status and delirium composed of 3 criteriaes
Time frame: baseline and the day of hospital discharge
Psychological status
Time frame: baseline and 3month after discharge
Frailtry
Time frame: baseline, day of hospital discharge and 3 month after discharge
Quality of life score
Time frame: baseline, day of hospital discharge, and 3 months after discharge
Composite criteria composed of two criteriaes : functional recovery and autonomy evolution
Time frame: 3 months after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Veronique CHAIGNEAU contact
Eric SCHMIDT study director
University Hospital of Toulouse
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ageing and Geriatric Health, run by University Hospital, Toulouse at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain, Portugal, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric SCHMIDT (05 61 77 56 06 ext. +33, schmidt.e@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The evolution of functional autonomy between baseline and 3 months post-discharge (time frame: between baseline and 3-month after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.