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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Sclerosis, Spinal Cord Injuries

Intervention / Treatment
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* Behavioral: Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: medical diagnosis of MS or spinal injury. ability to sign informed consent. Exclusion Criteria: other relevant previous neurological or psychiatric pathologies.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sexual therapy<br>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. | Behavioral: Therapy<br>* Discussion with therapist<br>|
| Active Comparator: Mindfulness<br>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. | Behavioral: Therapy<br>* Discussion with therapist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Before and after treatment (circa 6 weeks) | 
| 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 | Before and after treatment (circa 6 weeks) | 
| 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 | Before and after treatment (circa 6 weeks) | 
| 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 | Before and after treatment (circa 6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Before and after treatment (circa 6 weeks) | 
| 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. | Before and after treatment (circa 6 weeks) | 
| 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 | Before and after treatment (circa 6 weeks) | 
| 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 | Before and after treatment (circa 6 weeks) | 
| 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). | Before and after treatment (circa 6 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sexuality