Clinical trial NCT05142111: Pilot Study on EEG and Behavioral Effects of Two Different Treatments on Sexual Life
Official title: Pilot Study on EEG and Behavioral Effects of Two Different Treatments on Sexual Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Spinal Cord Injuries
Keywords: sexuality
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Changes in quality of actual and perceived sexual health for females
timeFrame: Before and after treatment (circa 6 weeks)
measure: Changes in quality of actual and perceived sexual health for males
timeFrame: Before and after treatment (circa 6 weeks)
measure: Changes in erectile function
timeFrame: Before and after treatment (circa 6 weeks)
measure: Changes in intimacy and sexuality
timeFrame: Before and after treatment (circa 6 weeks)
Secondary outcomes:
measure: Changes in brain spectral power after viewing neutral and erotic videos
timeFrame: Before and after treatment (circa 6 weeks)
measure: Changes in Mutual Information between brain regions after viewing neutral and erotic videos
timeFrame: Before and after treatment (circa 6 weeks)
measure: Psychological Well-Being
timeFrame: Before and after treatment (circa 6 weeks)
measure: Anxiety
timeFrame: Before and after treatment (circa 6 weeks)
measure: Changes in the assessment of the emotional response after viewing neutral and erotic videos
timeFrame: Before and after treatment (circa 6 weeks)
Other outcomes:
Locations:
city: Venice
country: Italy
facility: IRCCS San Camillo
Study officials:
affiliation: Investigator
name: Daniele Marinazzo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.