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

NCT ID: NCT05142111

Last Updated: 2023-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2025-03-31

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.

Conditions

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Multiple Sclerosis Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Sexual therapy

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.

Group Type EXPERIMENTAL

Therapy

Intervention Type BEHAVIORAL

Discussion with therapist

Mindfulness

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.

Group Type ACTIVE_COMPARATOR

Therapy

Intervention Type BEHAVIORAL

Discussion with therapist

Interventions

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Therapy

Discussion with therapist

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Camillo, Venezia, Italy

OTHER

Sponsor Role lead

Responsible Party

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Daniele Marinazzo

Scientific collaborator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniele Marinazzo, PhD

Role: PRINCIPAL_INVESTIGATOR

Investigator

Locations

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IRCCS San Camillo

Venice, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giorgio Arcara, PhD

Role: CONTACT

+390412207594

Facility Contacts

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Giorgio Arcara, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 9854964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31581254 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11354931 (View on PubMed)

Other Identifiers

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2020.12

Identifier Type: -

Identifier Source: org_study_id

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