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Pilot Study on EEG and Behavioral Effects of Two Different Treatments on Sexual Life (Seteb)

Primary Purpose

Multiple Sclerosis, Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Therapy
Sponsored by
IRCCS San Camillo, Venezia, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring sexuality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • medical diagnosis of MS or spinal injury.
  • ability to sign informed consent.

Exclusion Criteria:

  • other relevant previous neurological or psychiatric pathologies.

Sites / Locations

  • IRCCS San CamilloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sexual therapy

Mindfulness

Arm Description

In the sessions a series of questions will be proposed to the subject, who will be free to answer or not, being able to express questions in turn. The sessions will last about 45 minutes, and will be held once a week, for a total of 6 sessions.

During the mindfulness treatment the subjects will be subjected to sessions in which they will be invited to relax, to become aware of the present moment, of their body, through exercises that involve breathing, attention, and visualization of the body. The sessions will last about 45 minutes, and will be held once a week, for a total of 6 sessions.

Outcomes

Primary Outcome Measures

Changes in quality of actual and perceived sexual health for females
Assessed by means of a standardized questionnaire Female Sexual Dysfunction Questionnaire (Filocamo et al., 2014). 19 questions with 6 choices each. No maximum or minimum score defined. The experimenter evaluates the changes across sessions. This will be aggregated to other outcomes using factor analysis
Changes in quality of actual and perceived sexual health for males
Assessed by means of a standardized questionnaire MSHQ- (The Male Sexual Health Questionnaire). Questionnaire on male sexual health (Ugolini, & Pescatori, 2005). 25 questions with 5 or 6 choices each. No maximum or minimum score defined. The experimenter evaluates the changes across sessions. This will be aggregated to other outcomes using factor analysis
Changes in erectile function
Assessed by means of a standardized questionnaire IIEF5- (International Index of Erectile Function). Questionnaire aimed at calculating the International Index of Erectile Function (Rosen et al., 1997). 5 questions with scores 1 to 5. Outcome range 5-25. Lower scores indicate poorer outcomes. This will be aggregated to other outcomes using factor analysis
Changes in intimacy and sexuality
Assessed by means of a standardized questionnaire MSISQ-15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire). Questionnaire on Intimacy and Sexuality in People with a Medullary Injury (Monti et al., 2020). 15 items with scores 1 to 5 each. Outcome range 15-75. Higher scores indicate poorer outcomes. This will be aggregated to other outcomes using factor analysis

Secondary Outcome Measures

Changes in brain spectral power after viewing neutral and erotic videos
Changes in response of brain networks at rest and during viewing of emotional stimuli with sexual content. The recording will consist of 5 minutes of resting state (recording at rest). 8 total minutes of viewing of stimuli consisting of videos with an erotic and neutral emotional content. In particular, the subject will see two videos with an erotic content and two with an emotionally neutral content (the duration of each video is about 2 minutes). These stimuli will be selected from a standardized and validated visual battery for scientific studies presented in (Maffei & Angrilli, 2019). The spectral power across brain regions will be assessed by parametric spectral decomposition -presence and modulation of large scale patterns of correlated activity, assessed by means of measures of statistical dependency (correlation, mutual information)
Changes in Mutual Information between brain regions after viewing neutral and erotic videos
Changes in response of brain networks at rest and during viewing of emotional stimuli with sexual content. The recording will consist of 5 minutes of resting state (recording at rest). 8 total minutes of viewing of stimuli consisting of videos with an erotic and neutral emotional content. In particular, the subject will see two videos with an erotic content and two with an emotionally neutral content (the duration of each video is about 2 minutes). These stimuli will be selected from a standardized and validated visual battery for scientific studies presented in (Maffei & Angrilli, 2019). The presence and modulation of large scale patterns of correlated activity, assessed by means of mutual information (minimal value zero, maximum value not univocally defined, depending on the data distribution), will be investigated.
Psychological Well-Being
Assessed by means of a standardized questionnaire PWB (Psychological Well-Being Scale). Questionnaire aimed at defining the patient's psychological well-being profile through items that evaluate the dimensions of self-acceptance, autonomy, environmental control, life purpose, personal growth and positive relationships with others (Ruini et al., 2003). 42 items with scores 1-6 each. Outcome range 42-252. Higher values indicated better well-being. Questionnaire responses will be aggregated by factor analysis
Anxiety
Assessed by means of a standardized questionnaire BAI (Beck Anxiety Inventory). Questionnaire consisting of 21 items that describe anxiety in its subjective, neurophysiological and autonomic aspects. (Sica & Ghisi, 2007; Starosta & Brenner, 2018). The BAI has also been found to be a tool with high sensitivity to anxiety levels in patients with multiple sclerosis (Watson et al., 2014). 21 items, with scores 1-4 each. Outcome range 21-84. Higher values indicate higher anxiety. Questionnaire responses will be aggregated by factor analysis
Changes in the assessment of the emotional response after viewing neutral and erotic videos
Self-assessment questionnaires of the emotional content of stimuli, in particular the self-assessment manikin (SAM) will be used (Bradley MM, Lang PJ). With this questionnaire, through pictorial representations of "mannequins", the patient will be asked to evaluate his emotional reactions while watching the videos, in terms of the intensity of the emotions felt and the positive or negative values of the sensations experienced during the vision. 9 mannequins for valence (score 1:sad, score 9: happy). 9 mannequins for arousal (increasing level 1 to 9).

Full Information

First Posted
August 25, 2021
Last Updated
October 3, 2023
Sponsor
IRCCS San Camillo, Venezia, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT05142111
Brief Title
Pilot Study on EEG and Behavioral Effects of Two Different Treatments on Sexual Life
Acronym
Seteb
Official Title
Pilot Study on EEG and Behavioral Effects of Two Different Treatments on Sexual Life
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Camillo, Venezia, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study patients with Multiple Sclerosis or Spinal Lesions will participate in two different types of treatments that aim to improve sexual and sentimental life. Behavioral (via questionnaires) and brain (via high-density electroencephalogram) effects associated with treatment will be studied.
Detailed Description
People with neurological diseases can experience sexual disorders that can affect their quality of life. There are cognitive treatments to improve these aspects, but their effectiveness is not clear. The aim of this study is to test the potential efficacy of two treatments (mindfulness and sezual therapy) in two neurological populations (patients with multiple sclerosis and patients with spinal injury). To verify the effects of the treatment, questionnaires and brain activity measurements, measured by electroencephalogram, will be used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Spinal Cord Injuries
Keywords
sexuality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sexual therapy
Arm Type
Experimental
Arm Description
In the sessions a series of questions will be proposed to the subject, who will be free to answer or not, being able to express questions in turn. The sessions will last about 45 minutes, and will be held once a week, for a total of 6 sessions.
Arm Title
Mindfulness
Arm Type
Active Comparator
Arm Description
During the mindfulness treatment the subjects will be subjected to sessions in which they will be invited to relax, to become aware of the present moment, of their body, through exercises that involve breathing, attention, and visualization of the body. The sessions will last about 45 minutes, and will be held once a week, for a total of 6 sessions.
Intervention Type
Behavioral
Intervention Name(s)
Therapy
Intervention Description
Discussion with therapist
Primary Outcome Measure Information:
Title
Changes in quality of actual and perceived sexual health for females
Description
Assessed by means of a standardized questionnaire Female Sexual Dysfunction Questionnaire (Filocamo et al., 2014). 19 questions with 6 choices each. No maximum or minimum score defined. The experimenter evaluates the changes across sessions. This will be aggregated to other outcomes using factor analysis
Time Frame
Before and after treatment (circa 6 weeks)
Title
Changes in quality of actual and perceived sexual health for males
Description
Assessed by means of a standardized questionnaire MSHQ- (The Male Sexual Health Questionnaire). Questionnaire on male sexual health (Ugolini, & Pescatori, 2005). 25 questions with 5 or 6 choices each. No maximum or minimum score defined. The experimenter evaluates the changes across sessions. This will be aggregated to other outcomes using factor analysis
Time Frame
Before and after treatment (circa 6 weeks)
Title
Changes in erectile function
Description
Assessed by means of a standardized questionnaire IIEF5- (International Index of Erectile Function). Questionnaire aimed at calculating the International Index of Erectile Function (Rosen et al., 1997). 5 questions with scores 1 to 5. Outcome range 5-25. Lower scores indicate poorer outcomes. This will be aggregated to other outcomes using factor analysis
Time Frame
Before and after treatment (circa 6 weeks)
Title
Changes in intimacy and sexuality
Description
Assessed by means of a standardized questionnaire MSISQ-15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire). Questionnaire on Intimacy and Sexuality in People with a Medullary Injury (Monti et al., 2020). 15 items with scores 1 to 5 each. Outcome range 15-75. Higher scores indicate poorer outcomes. This will be aggregated to other outcomes using factor analysis
Time Frame
Before and after treatment (circa 6 weeks)
Secondary Outcome Measure Information:
Title
Changes in brain spectral power after viewing neutral and erotic videos
Description
Changes in response of brain networks at rest and during viewing of emotional stimuli with sexual content. The recording will consist of 5 minutes of resting state (recording at rest). 8 total minutes of viewing of stimuli consisting of videos with an erotic and neutral emotional content. In particular, the subject will see two videos with an erotic content and two with an emotionally neutral content (the duration of each video is about 2 minutes). These stimuli will be selected from a standardized and validated visual battery for scientific studies presented in (Maffei & Angrilli, 2019). The spectral power across brain regions will be assessed by parametric spectral decomposition -presence and modulation of large scale patterns of correlated activity, assessed by means of measures of statistical dependency (correlation, mutual information)
Time Frame
Before and after treatment (circa 6 weeks)
Title
Changes in Mutual Information between brain regions after viewing neutral and erotic videos
Description
Changes in response of brain networks at rest and during viewing of emotional stimuli with sexual content. The recording will consist of 5 minutes of resting state (recording at rest). 8 total minutes of viewing of stimuli consisting of videos with an erotic and neutral emotional content. In particular, the subject will see two videos with an erotic content and two with an emotionally neutral content (the duration of each video is about 2 minutes). These stimuli will be selected from a standardized and validated visual battery for scientific studies presented in (Maffei & Angrilli, 2019). The presence and modulation of large scale patterns of correlated activity, assessed by means of mutual information (minimal value zero, maximum value not univocally defined, depending on the data distribution), will be investigated.
Time Frame
Before and after treatment (circa 6 weeks)
Title
Psychological Well-Being
Description
Assessed by means of a standardized questionnaire PWB (Psychological Well-Being Scale). Questionnaire aimed at defining the patient's psychological well-being profile through items that evaluate the dimensions of self-acceptance, autonomy, environmental control, life purpose, personal growth and positive relationships with others (Ruini et al., 2003). 42 items with scores 1-6 each. Outcome range 42-252. Higher values indicated better well-being. Questionnaire responses will be aggregated by factor analysis
Time Frame
Before and after treatment (circa 6 weeks)
Title
Anxiety
Description
Assessed by means of a standardized questionnaire BAI (Beck Anxiety Inventory). Questionnaire consisting of 21 items that describe anxiety in its subjective, neurophysiological and autonomic aspects. (Sica & Ghisi, 2007; Starosta & Brenner, 2018). The BAI has also been found to be a tool with high sensitivity to anxiety levels in patients with multiple sclerosis (Watson et al., 2014). 21 items, with scores 1-4 each. Outcome range 21-84. Higher values indicate higher anxiety. Questionnaire responses will be aggregated by factor analysis
Time Frame
Before and after treatment (circa 6 weeks)
Title
Changes in the assessment of the emotional response after viewing neutral and erotic videos
Description
Self-assessment questionnaires of the emotional content of stimuli, in particular the self-assessment manikin (SAM) will be used (Bradley MM, Lang PJ). With this questionnaire, through pictorial representations of "mannequins", the patient will be asked to evaluate his emotional reactions while watching the videos, in terms of the intensity of the emotions felt and the positive or negative values of the sensations experienced during the vision. 9 mannequins for valence (score 1:sad, score 9: happy). 9 mannequins for arousal (increasing level 1 to 9).
Time Frame
Before and after treatment (circa 6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: medical diagnosis of MS or spinal injury. ability to sign informed consent. Exclusion Criteria: other relevant previous neurological or psychiatric pathologies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giorgio Arcara, PhD
Phone
+390412207594
Email
n.ricercaclinica@ospedalesancamillo.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniele Marinazzo, PhD
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS San Camillo
City
Venice
ZIP/Postal Code
30126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giorgio Arcara, PhD
Email
n.ricercaclinica@hsancamillo.it

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The investigators are trying to figure out compliance to EU GDPR, its interpretation in Italy, and the institutional requirements
Citations:
PubMed Identifier
9854964
Citation
Chandler BJ, Brown S. Sex and relationship dysfunction in neurological disability. J Neurol Neurosurg Psychiatry. 1998 Dec;65(6):877-80. doi: 10.1136/jnnp.65.6.877.
Results Reference
background
PubMed Identifier
31581254
Citation
Maffei A, Angrilli A. E-MOVIE - Experimental MOVies for Induction of Emotions in neuroscience: An innovative film database with normative data and sex differences. PLoS One. 2019 Oct 3;14(10):e0223124. doi: 10.1371/journal.pone.0223124. eCollection 2019.
Results Reference
background
PubMed Identifier
11354931
Citation
McCabe MP. Evaluation of a cognitive behavior therapy program for people with sexual dysfunction. J Sex Marital Ther. 2001 May-Jun;27(3):259-71. doi: 10.1080/009262301750257119.
Results Reference
background

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Pilot Study on EEG and Behavioral Effects of Two Different Treatments on Sexual Life

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