Using non-invasive neuromodulation to help stroke recovery
Non-invasive Neuromodulation NESA Application in the Rehabilitation of Stroke Sequelae. A Pilot Study
This study is testing whether a new non-invasive treatment using microcurrents can help stroke survivors improve their balance, reduce pain, and manage spasticity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Las Palmas de Gran Canaria Academic / other |
| Locations | 1 site (Las Palmas de Gran Canaria, Las Palmas) |
| Trial ID | NCT05853952 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effectiveness of NESA microcurrents as a treatment for various complications following a stroke, including spasticity, balance issues, and pain. It involves 30 stroke patients who are between 6 months and 4 years post-stroke and able to stand upright. Participants will be randomly assigned to either a treatment group receiving real stimulation or a placebo group, with both the physiotherapist and patients unaware of their group assignment. The intervention consists of 20 sessions of treatment, each lasting one hour, using the NESA X-Signal device.
Who should consider this trial
Good fit: Ideal candidates are stroke survivors aged between 6 months and 4 years post-stroke who can stand upright and have the cognitive capacity to participate.
Not a fit: Patients with contraindications such as pacemakers, skin conditions, or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes and quality of life for stroke patients.
How similar studies have performed: While this approach is relatively novel, similar studies in neuromodulation have shown promising results in improving rehabilitation outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Las Palmas de Gran Canaria, Las Palmas
- Mariola Lledó Amat — Las Palmas de Gran Canaria, Las Palmas, Spain (Recruiting)
Study contacts
- Principal investigator: Mariola Lledó Amat, MSc — University of Las Palmas de Gran Canaria
- Study coordinator: Mariola Lledó Amat, MSc
- Email: mariola.lledo101@alu.ulpgc.es
- Phone: +34 637 87 68 50
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.