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

NCT ID: NCT03154801

Last Updated: 2022-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-26
• Study Completion Date: 2022-07-26

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.

Conditions

Low Grade Glioma of Brain; Multiple Sclerosis; Sexual Dysfunctions

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paramedical care

paramedical early detection of sexual dysfunction and sexual health counseling

Group Type: EXPERIMENTAL

Paramedical care

Intervention Type: OTHER

Paramedical early detection of sexual dysfunction and sexual health counseling

Interventions

Paramedical care

Paramedical early detection of sexual dysfunction and sexual health counseling

Intervention Type: OTHER

Eligibility Criteria

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

1. Any patient partner, whose patient has wished to participate and who has accepted.

2. Signing of informed consent

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

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:

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Groupe Hospitalier Pitie Salpetriere

Paris, , France

Countries

France

Other Identifiers

P140709

Identifier Type: -

Identifier Source: org_study_id