NCT05853952

Non-invasive Neuromodulation NESA Application in the Rehabilitation of Stroke Sequelae

Non-invasive Neuromodulation NESA Application in the Rehabilitation of Stroke Sequelae. A Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Las Palmas de Gran Canaria · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate whether NESA microcurrents can be used as an effective treatment for various sequelae present in stroke patients, specifically in the treatment of spasticity, balance, pain; and whether it affects quality of life, performance of activities of daily living and quality of sleep.

Detailed description

Pilot study following a randomized controlled trial design, designed to study the feasibility of a study with a larger sample size. Intervention of 30 stroke participants with an evolution between 6 months and 4 years since the stroke, who are able to stand upright. These participants will be recruited voluntarily through a campaign in social networks and with the collaboration of local associations and institutions. Once the inclusion and exclusion criteria have been reviewed, they will be randomly assigned to an intervention group and a placebo group. A double-blind recruitment system will be followed in which the physiotherapist and patients will not know whether they are receiving real or simulated stimulation, for this purpose two NESA XSIGNAL® devices will be used in double-blind mode. Treatment of 20 sessions per patient, of 1 hour duration each, with the NESA X-Signal device.

Conditions

• Stroke

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: 2023-04-24
• Primary completion: 2025-11-24
• Completion: 2026-04-23
• First posted: 2023-05-11
• Last updated: 2025-08-22

Locations

1 site across 1 country: Spain