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

Multiple Sclerosis Clinical Trial

— Seteb  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05142111
• Other study ID #: 2020.12
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: October 2023
• Source: IRCCS San Camillo, Venezia, Italy
• Contact: Giorgio Arcara, PhD
• Phone: +390412207594
• Email: n.ricercaclinica[@]ospedalesancamillo.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• medical diagnosis of MS or spinal injury.

• ability to sign informed consent.

Exclusion Criteria:

• other relevant previous neurological or psychiatric pathologies.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Spinal Cord Injuries

Intervention

Behavioral:
• Therapy
Discussion with therapist

Locations

Country	Name	City	State
Italy	IRCCS San Camillo	Venice

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Camillo, Venezia, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)