RecruitingNot ApplicableNCT05853952

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


Sponsor

University of Las Palmas de Gran Canaria

Enrollment

30 participants

Start Date

Apr 24, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • People who have suffered a stroke with an evolution between 6 months and 6 years.
  • Optimal cognitive capacity and mentally competent to participate in the study and complete the required questionnaires.
  • People able of standing upright, including those who need technical aids.

Exclusion Criteria4

  • Present some of the contraindications for a treatment with NESA XSIGNAL®: pacemakers, internal bleeding, not to apply electrodes on skin in bad condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and/or phobia to electricity.
  • Not having signed the informed consent form.
  • Presenting any additional injury or pathology during the study.
  • Not having the optimal cognitive capacities for understanding and participating in the study.

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Interventions

DEVICENon-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

DEVICEPlacebo 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.


Locations(1)

Mariola Lledó Amat

Las Palmas de Gran Canaria, Las Palmas, Spain

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NCT05853952


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