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

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Sexual Dysfunctions; Multiple Sclerosis; Low Grade Glioma of Brain

Treatments: Other: Paramedical care

Study type: Interventional

Funder types: Other

Identifiers

NCT03154801

P140709

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

54 participants in 1 patient group

Paramedical care

Experimental group

Description:

paramedical early detection of sexual dysfunction and sexual health counseling

Treatment:

Other: Paramedical care