Multiple SclerosisSetebNCT05142111
Pilot Study on EEG and Behavioral Effects of Two Different Treatments on Sexual Life
A study testing Therapy in people with Multiple Sclerosis and Spinal Cord Injuries, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Spinal Cord Injuries
- What is being tested?
- Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2021to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medical diagnosis of MS or spinal injury.
- ability to sign informed consent.
Who cannot join
- other relevant previous neurological or psychiatric pathologies.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Camillo
Venice, 30126
Giorgio Arcara, PhD, n.ricercaclinica@hsancamillo.it
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Spinal Cord Injuries
- Being tested
- Therapy
- Keywords
- sexuality
- Medical subject headings
- Multiple Sclerosis, Spinal Cord Injuries, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TherapyBehavioural
Discussion with therapist
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Before and after treatment (circa 6 weeks)
Secondary outcomes (5)
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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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).
Measured: Before and after treatment (circa 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start1 Apr 2021
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniele Marinazzo, IRCCS San Camillo, Venezia, Italy
- Investigators
- Daniele Marinazzo, PhD, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142111
- Sponsor's protocol ID
- 2020.12
- Acronym
- Seteb
- Status last verified
- Oct 2023
- First submitted
- 25 Aug 2021
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators are trying to figure out compliance to EU GDPR, its interpretation in Italy, and the institutional requirements
Publications
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.
PubMed 9854964Maffei 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.
PubMed 31581254McCabe 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.
PubMed 11354931
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on EEG and Behavioral Effects of Two Different Treatments on Sexual Life
- ClinicalTrials.gov ID
- NCT05142111
- Acronym / sponsor ID
- Seteb / 2020.12
- Conditions
- Multiple Sclerosis, Spinal Cord Injuries
- Keywords
- sexuality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sexual therapy | Experimental | Behavioral: TherapyIn 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. |
| Mindfulness | Active comparator | Behavioral: TherapyDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- medical diagnosis of MS or spinal injury.
- ability to sign informed consent.
Key exclusion criteria (1 listed)
- other relevant previous neurological or psychiatric pathologies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TherapyDiscussion with therapist | Behavioural | Mindfulness, Sexual therapy |
Primary outcome
Changes in quality of actual and perceived sexual health for females
Time frame: Before and after treatment (circa 6 weeks)
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
Time frame: Before and after treatment (circa 6 weeks)
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
Time frame: Before and after treatment (circa 6 weeks)
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
Time frame: Before and after treatment (circa 6 weeks)
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
5 secondary outcomes
Changes in brain spectral power after viewing neutral and erotic videos
Time frame: Before and after treatment (circa 6 weeks)
Changes in Mutual Information between brain regions after viewing neutral and erotic videos
Time frame: Before and after treatment (circa 6 weeks)
Psychological Well-Being
Time frame: Before and after treatment (circa 6 weeks)
Anxiety
Time frame: Before and after treatment (circa 6 weeks)
Changes in the assessment of the emotional response after viewing neutral and erotic videos
Time frame: Before and after treatment (circa 6 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Background: PubMed 9854964Chandler 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.
- Background: PubMed 31581254Maffei 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.
- Background: PubMed 11354931McCabe 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.
- Individual participant dataSharing planned: Undecided. The investigators are trying to figure out compliance to EU GDPR, its interpretation in Italy, and the institutional requirements
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniele Marinazzo, PhD principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy in people with Multiple Sclerosis and Spinal Cord Injuries, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giorgio Arcara, PhD (+390412207594, n.ricercaclinica@ospedalesancamillo.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in quality of actual and perceived sexual health for females (time frame: Before and after treatment (circa 6 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05142111, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.