NCT05648695

Efficacy of Non-invasive NESA Neuromodulation in Fibromyalgia

Efficacy of Non-invasive NESA Neuromodulation in Fibromyalgia: a Randomised, Triple-blind Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Las Palmas de Gran Canaria · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Fibromyalgia is a chronic condition that causes pain throughout the body, fatigue and other symptoms. Among the most common clinical symptoms are sleep and anxiety disorders. All these symptoms are very disabling and have a negative impact on the quality of life of these people. There is currently no curative treatment for this pathology and current treatments focus their efforts on reducing the intensity of the symptoms. The current approach is mainly pharmacological, with the possible side effects that this entails.

Detailed description

The NESA XSIGNAL® device is a non-invasive, low-frequency neuromodulation device that uses microcurrents to restore the electrical balance in the body. This technology is approved as medical equipment and is CE marked (attached in separate files). This non-invasive neuromodulation equipment is beginning to show promising results in patients with sleep disorders. So it can be a useful tool to reduce the impact on the quality of life of people with fibromyalgia.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DEVICE	Non-invasive Neuromodulation	The electrodes will be placed with the help of gloves and adapted socks for 1 hour, each session, until 13 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7. Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 millivolt and intensity 0.5 μA.
DEVICE	Placebo Non-invasive Neuromodulation	The same protocol described for the experimental group will be applied, but microcurrents device which will be previously manipulated and tested with an oscilloscope so that they do not emit electrical currents.

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-04-01
• Completion: 2023-04-21
• First posted: 2022-12-13
• Last updated: 2023-04-25

Locations

1 site across 1 country: Spain