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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-24

Study Completion Date

2026-04-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Stroke, Measurement and Rehabilitation

NCT05497791

Stroke

COMPLETED NA

Effectiveness of Neuromuscular Electrical Stimulation After Stroke

NCT03913624

Stroke

COMPLETED NA

Pilot Study of EMG-Directed Virtual-Reality Experience Training for Motor Stroke Rehabilitation

NCT05253989

Stroke Spinal Cord Injuries

UNKNOWN NA

Stochastic Resonance Stimulation in Brain Plasticity and Post Stroke Motor Recovery

NCT03839810

Stroke, Ischemic Healthy

UNKNOWN NA

Effects of Neuromuscular Electrical Stimulation in Muscle Architecture and Functionality of Patients After Acute Stroke

NCT03840954

Stroke, Acute Neuromuscular Electrical Stimulation

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Non-invasive Neuromodulation

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

Group Type EXPERIMENTAL

Non-invasive Neuromodulation

Intervention Type DEVICE

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

Placebo Non-invasive Neuromodulation

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

Group Type PLACEBO_COMPARATOR

Placebo Non-invasive Neuromodulation

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No