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

NCT05142111 | Unknown DMC

• 1 other identifier: 2020.12
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Spinal Cord Injuries

Keywords

sexuality

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Changes in brain spectral power after viewing neutral and erotic videos

  Before and after treatment (circa 6 weeks)

• Changes in Mutual Information between brain regions after viewing neutral and erotic videos

  Before and after treatment (circa 6 weeks)

• Psychological Well-Being

  Before and after treatment (circa 6 weeks)

• Anxiety

  Before and after treatment (circa 6 weeks)

• Changes in the assessment of the emotional response after viewing neutral and erotic videos

  Before and after treatment (circa 6 weeks)

Study Arms (2)

Sexual therapy

EXPERIMENTAL

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

Mindfulness

ACTIVE COMPARATOR

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

Interventions

Therapy BEHAVIORAL

Discussion with therapist

Mindfulness; Sexual therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• other relevant previous neurological or psychiatric pathologies.

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead

Study Sites (1)

IRCCS San Camillo

Venice, 30126, Italy

RECRUITING

Related 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.

  PMID: 9854964 BACKGROUND

• 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.

  PMID: 31581254 BACKGROUND

• 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.

  PMID: 11354931 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Spinal Cord Injuries; Sexuality

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Sexual Behavior; Behavior

Study Officials

• Daniele Marinazzo, PhD

  Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giorgio Arcara, PhD

CONTACT

+390412207594; n.ricercaclinica@ospedalesancamillo.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific collaborator

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: December 2, 2021
• Study Start: April 1, 2021
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: October 4, 2023

Record last verified: 2023-10

Locations

IT (1)