Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304558
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-19
Brief Title:
Effectiveness of Non-invasive Neuromodulation Treatment for Improving Sexual Satisfaction in Healthy Subjects
Sponsor:
Universidad Europea de Madrid
Organization:
Universidad Europea de Madrid
Study Overview
Official Title:
Effectiveness of Non-invasive Neuromodulation Treatment NESA for Improving Sexual Satisfaction in Healthy Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objectives of the programming with the XSignal device will be to influence the sexual satisfaction of the participants
As secondary objectives the effectiveness of the XSignal device during a defined treatment period will be analyzed in terms of quality of life pain stress anxiety sexual function sleep quality cortisol heart rate blood pressure respiratory rate and body temperature of the same subjects compared with a placebo group observing the long-term influence of the results
As secondary objectives the effectiveness of the XSignal device during a defined treatment period will be analyzed in terms of quality of life pain stress anxiety sexual function sleep quality cortisol heart rate blood pressure respiratory rate and body temperature of the same subjects compared with a placebo group observing the long-term influence of the results
Detailed Description:
Considering the objectives set In the first phase the directing electrode will be located at C6-C7 to generate a systemic and general effect on the organism with program 1 program 2 program 7 and program 8 In the second phase the directing electrode will be placed at the abdominal level in the area of the mesenteric plexus to influence the sympathetic innervation of the viscera In the third phase the directing electrode is located at S2-S3 to concentrate the action of the therapy on the sacral parasympathetic plexus In this way both the sympathetic and parasympathetic innervation of the main sexual organs are covered through the sympathetic paravertebral ganglia and the sacral plexus
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None