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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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
• Устройство 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.

Первичные конечные точки

• Change in Pain assessed by VAS [Срок оценки: Up to 7 weeks]
• Change in Sleep quality [Срок оценки: Up to 7 weeks]
• Changes in quality of life [Срок оценки: Up to 7 weeks]
• Changes in the level of autonomy [Срок оценки: Up to 7 weeks]
• Changes in their ability to balance [Срок оценки: Up to 7 weeks]
• Changes in muscle tone [Срок оценки: Up to 7 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Mariola Lledó Amat — Las Palmas de Gran Canaria

Публикации

• Li L, Scott CA, Rothwell PM; Oxford Vascular Study. Trends in Stroke Incidence in High-Income Countries in the 21st Century: Population-Based Study and Systematic Review. Stroke. 2020 May;51(5):1372-1380. doi: 10.1161/STROKEAHA.119.028484. Epub 2020 Mar 25. PMID 32208842
• McKevitt C, Fudge N, Redfern J, Sheldenkar A, Crichton S, Rudd AR, Forster A, Young J, Nazareth I, Silver LE, Rothwell PM, Wolfe CD. Self-reported long-term needs after stroke. Stroke. 2011 May;42(5):1398-403. doi: 10.1161/STROKEAHA.110.598839. Epub 2011 Mar 24. PMID 21441153
• Crichton SL, Bray BD, McKevitt C, Rudd AG, Wolfe CD. Patient outcomes up to 15 years after stroke: survival, disability, quality of life, cognition and mental health. J Neurol Neurosurg Psychiatry. 2016 Oct;87(10):1091-8. doi: 10.1136/jnnp-2016-313361. Epub 2016 Jul 22. PMID 27451353

Идентификаторы

NCT: NCT05853952 · NESA ICTUS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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