Clinical trial NCT05853952: Non-invasive Neuromodulation NESA Application in the Rehabilitation of Stroke Sequelae
Official title: Non-invasive Neuromodulation NESA Application in the Rehabilitation of Stroke Sequelae. A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: physical therapy modality
Electric Stimulation Therapy
Lead sponsor: University of Las Palmas de Gran Canaria
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change in Pain assessed by VAS
timeFrame: Up to 7 weeks
measure: Change in Sleep quality
timeFrame: Up to 7 weeks
measure: Changes in quality of life
timeFrame: Up to 7 weeks
measure: Changes in the level of autonomy
timeFrame: Up to 7 weeks
measure: Changes in their ability to balance
timeFrame: Up to 7 weeks
measure: Changes in muscle tone
timeFrame: Up to 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Las Palmas De Gran Canaria
country: Spain
facility: Mariola Lledó Amat
state: Las Palmas
Study officials:
affiliation: University of Las Palmas de Gran Canaria
name: Mariola Lledó Amat, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.