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Early Detection and Paramedical Care of Sexual Difficulties in Nervous System Diseases: Example of Multiple Sclerosis and Brain Tumors (NEUROSEX)

Early Detection and Paramedical Care of Sexual Difficulties in Nervous System Diseases: Example of Multiple Sclerosis and Brain Tumors

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03154801
Acronym
NEUROSEX
Enrollment
54
Registered
2017-05-16
Start date
2017-07-26
Completion date
2022-07-26
Last updated
2022-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Grade Glioma of Brain, Multiple Sclerosis, Sexual Dysfunctions

Brief summary

This study aim to ensure that the implementation of a paramedical screening program and counseling in sexual health of patients with neurological pathologies (low-grade gliomas and Multiple Sclerosis) improves their sexual health.

Interventions

OTHERParamedical care

Paramedical early detection of sexual dysfunction and sexual health counseling

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Any major patient, followed in the GHPSCF (Groupe Hospitalier Pitié-Salpêtrière Charles Foix) neurology department 2 for a diagnosis of low grade glioma or anaplastic glioma with loss 1p / 19q sub-reserve histo-molecular confirmation after national reading (POLA) and presenting: * An MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire) questionnaire with at least one of the items rated 4 or 5 and * A HAD (Hospital Anxiety and Depression) questionnaire (depression component) with a score ≤ 11 2. Any major patient with MS(Multiple Sclerosis), followed in the GHPSCF Department of Neurology: * With an EDSS (Expanded Disability Status Scale) greater than or equal to 1 and * An MSISQ15 questionnaire with at least one of the items rated 4 or 5. * A HAD questionnaire (depression component) with a score ≤ 11 3. Signature of informed consent 4. Patient affiliated to a social security system

Exclusion criteria

1. Minor patients 2. Pregnant women 3. Patients who do not understand and / or speak French and / or are unable to sign consent 4. Patients with neurological impairment 5. Patients with chronic sexual disorders who have already received treatment. 6. Patients with a HAD score (depression component) greater than 11 7. Patients with MS who had a corticosteroid-treated outbreak in the last two months. 8. Patients with low-grade glioma with clinical and / or radiological scalability during the last three months 9. Any patient whose alteration of the general state would not allow to follow the program. 10. Patients under legal protection For patient's partners: Inclusion criteria: 1. Any patient partner, whose patient has wished to participate and who has accepted. 2. Signing of informed consent Non-Inclusion Criteria: 1. Minor partners 2. Pregnant women 3. Any person who does not understand and / or speak French and / or is unable to sign the consent 4. Partners under legal protection

Design outcomes

Primary

MeasureTime frameDescription
Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)Inclusion and 3 monthsChange of MSISQ15 sexual dysfunctional items at 3-months from baseline

Secondary

MeasureTime frameDescription
Change of HAD scale (Hospital Anxiety and Depression)Inclusion and 3 monthsChange of HAD scale score at 3-months from baseline
Change of Rosenberg's Self-esteem ScaleInclusion and 3 monthsChange of Rosenberg's Self-esteem Scale score at 3-months from baseline
Change of Quality of life scaleInclusion and 3 monthsChange of Quality of life scale score at 3-months from baseline
Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)Inclusion and 6-monthsChange of MSISQ15 sexual dysfunctional items at 6-months from baseline
Change of SEP59 scale (Sclérose En Plaques)Inclusion and 3 monthsChange of SEP59 scale score at 3-months from baseline
Program satisfaction scale3 monthsProgram satisfaction scale scores at 3-months
Change of QLQ-C30/BM20 scale (Quality of Life Questionnaire - Core Questionnaire / Brain Module)Inclusion and 3 monthsChange of QLQC30/BM20 score at 3-months from baseline

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026