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

February 17, 2022 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Groupe Hospitalier Pitié Salpêtrière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Paramedical care
paramedical early detection of sexual dysfunction and sexual health counseling
Other: Paramedical care
Paramedical early detection of sexual dysfunction and sexual health counseling

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)
Time Frame: Inclusion and 3 months
Change of MSISQ15 sexual dysfunctional items at 3-months from baseline
Inclusion and 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire)
Time Frame: Inclusion and 6-months
Change of MSISQ15 sexual dysfunctional items at 6-months from baseline
Inclusion and 6-months
Change of HAD scale (Hospital Anxiety and Depression)
Time Frame: Inclusion and 3 months
Change of HAD scale score at 3-months from baseline
Inclusion and 3 months
Change of HAD scale (Hospital Anxiety and Depression)
Time Frame: Inclusion and 6 months
Change of HAD scale score at 6-months from baseline
Inclusion and 6 months
Change of Rosenberg's Self-esteem Scale
Time Frame: Inclusion and 3 months
Change of Rosenberg's Self-esteem Scale score at 3-months from baseline
Inclusion and 3 months
Change of Rosenberg's Self-esteem Scale
Time Frame: Inclusion and 6 months
Change of Rosenberg's Self-esteem Scale score at 6-months from baseline
Inclusion and 6 months
Change of Quality of life scale
Time Frame: Inclusion and 3 months
Change of Quality of life scale score at 3-months from baseline
Inclusion and 3 months
Change of Quality of life scale
Time Frame: Inclusion and 6 months
Change of Quality of life scale score at 6-months from baseline
Inclusion and 6 months
Change of QLQ-C30/BM20 scale (Quality of Life Questionnaire - Core Questionnaire / Brain Module)
Time Frame: Inclusion and 3 months
Change of QLQC30/BM20 score at 3-months from baseline
Inclusion and 3 months
Change of QLQ-C30/BM20 scale (Quality of Life Questionnaire - Core Questionnaire / Brain Module)
Time Frame: Inclusion and 6 months
Assessment of QLQC30/BM20 score at 6-months from baseline
Inclusion and 6 months
Change of SEP59 scale (Sclérose En Plaques)
Time Frame: Inclusion and 3 months
Change of SEP59 scale score at 3-months from baseline
Inclusion and 3 months
Change of SEP59 scale (Sclérose En Plaques)
Time Frame: Inclusion and 6 months
Change of SEP59 scale score at 6-months from baseline
Inclusion and 6 months
Program satisfaction scale
Time Frame: 3 months
Program satisfaction scale scores at 3-months
3 months
Program satisfaction scale
Time Frame: 6 months
Program satisfaction scale scores at 6-months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 26, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P140709

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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