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

Multiple Sclerosis Clinical Trial

— NEUROSEX  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03154801
• Other study ID #: P140709
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 26, 2017
• Est. completion date: July 26, 2022

Study information

• Verified date: February 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: July 26, 2022
• Est. primary completion date: January 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Low Grade Glioma of Brain
• Multiple Sclerosis
• Nervous System Diseases
• Sclerosis
• Sexual Dysfunctions

Intervention

Other:
• Paramedical care
Paramedical early detection of sexual dysfunction and sexual health counseling

Locations

Country	Name	City	State
France	Groupe Hospitalier Pitie Salpetriere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)	Change of MSISQ15 sexual dysfunctional items at 3-months from baseline	Inclusion and 3 months
Secondary	Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)	Change of MSISQ15 sexual dysfunctional items at 6-months from baseline	Inclusion and 6-months
Secondary	Change of HAD scale (Hospital Anxiety and Depression)	Change of HAD scale score at 3-months from baseline	Inclusion and 3 months
Secondary	Change of HAD scale (Hospital Anxiety and Depression)	Change of HAD scale score at 6-months from baseline	Inclusion and 6 months
Secondary	Change of Rosenberg's Self-esteem Scale	Change of Rosenberg's Self-esteem Scale score at 3-months from baseline	Inclusion and 3 months
Secondary	Change of Rosenberg's Self-esteem Scale	Change of Rosenberg's Self-esteem Scale score at 6-months from baseline	Inclusion and 6 months
Secondary	Change of Quality of life scale	Change of Quality of life scale score at 3-months from baseline	Inclusion and 3 months
Secondary	Change of Quality of life scale	Change of Quality of life scale score at 6-months from baseline	Inclusion and 6 months
Secondary	Change of QLQ-C30/BM20 scale (Quality of Life Questionnaire - Core Questionnaire / Brain Module)	Change of QLQC30/BM20 score at 3-months from baseline	Inclusion and 3 months
Secondary	Change of QLQ-C30/BM20 scale (Quality of Life Questionnaire - Core Questionnaire / Brain Module)	Assessment of QLQC30/BM20 score at 6-months from baseline	Inclusion and 6 months
Secondary	Change of SEP59 scale (Sclérose En Plaques)	Change of SEP59 scale score at 3-months from baseline	Inclusion and 3 months
Secondary	Change of SEP59 scale (Sclérose En Plaques)	Change of SEP59 scale score at 6-months from baseline	Inclusion and 6 months
Secondary	Program satisfaction scale	Program satisfaction scale scores at 3-months	3 months
Secondary	Program satisfaction scale	Program satisfaction scale scores at 6-months	6 months