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

University of Las Palmas de Gran Canaria

Status: Enrolling

Conditions: Stroke

Treatments: Device: Placebo Non-invasive Neuromodulation; Device: Non-invasive Neuromodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05853952

NESA ICTUS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Non-invasive Neuromodulation

Experimental group

Description:

The non-invasive neuromodulation experimental group, are treated 20 sessions with the NXSignal non-invasive neuromodulation device (NESA)

Treatment:

Device: Non-invasive Neuromodulation

Placebo Non-invasive Neuromodulation

Placebo Comparator group

Description:

The non-invasive neuromodulation placebo group, are treated 20 sessions with the NXSignal non-invasive neuromodulation device (NESA)

Treatment:

Device: Placebo Non-invasive Neuromodulation