StrokeNCT05853952
Non-invasive Neuromodulation NESA Application in the Rehabilitation of Stroke Sequelae
A study testing Non-invasive Neuromodulation in people with Stroke, run by University of Las Palmas de Gran Canaria at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Non-invasive Neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 24 Apr 2023to 23 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Mariola Lledó Amat
Las Palmas de Gran Canaria, Las Palmas, 35016
Mariola Lledó Amat, MSc, +34 637 87 68 50, mariola.lledo101@alu.ulpgc.es
Raquel Medina-Ramírez, PhD
About this study
Official title: Non-invasive Neuromodulation NESA Application in the Rehabilitation of Stroke Sequelae. A Pilot Study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Non-invasive Neuromodulation, Placebo Non-invasive Neuromodulation
- Keywords
- physical therapy modality, Electric Stimulation Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive NeuromodulationDevice
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 NeuromodulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive Neuromodulation | Experimental | The non-invasive neuromodulation experimental group, are treated 20 sessions with the NXSignal non-invasive neuromodulation device (NESA) Receives: Device: Non-invasive Neuromodulation |
| Placebo Non-invasive Neuromodulation | Placebo comparator | The non-invasive neuromodulation placebo group, are treated 20 sessions with the NXSignal non-invasive neuromodulation device (NESA) Receives: Device: Placebo Non-invasive Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain assessed by VAS
The instrument will be used to measure the change of pain before and after the intervention will be the Visual Analogue Scale (VAS).
Participants will be asked to mark the level of their pain on a 100 mm, no hatched VAS scale marked at one end as "no pain" and at the other as "worst pain imaginable".
Measured: Up to 7 weeks
Change in Sleep quality
The Pittsburgh Sleep Quality Index (PSQI) will be used. It consists of 19 self-administered questions and 5 questions assessed by the patient's partner or roommate (if available). Only the self-administered questions are included in the score.
The higher the total score, the worse the sleep quality. Thus, a total score less than or equal to five on the Pittsburgh scale indicates that, in general, your sleep quality is optimal, while a total score greater than five suggests that you have sleep problems, of greater or lesser severity.
Measured: Up to 7 weeks
Changes in quality of life
The Stroke-specific quality of life scale ( ECVI-38) is a specific scale for stroke patients. This instrument includes 38 items divided into eight subgroups: physical status, communication, cognition, emotions, feelings, basic activities of daily living, common activities of daily living and socio-familial functioning.
The format presents five response possibilities: 5 represents the worst situation and 1 represents the absence of the problem.
Measured: Up to 7 weeks
Changes in the level of autonomy
The Barthel index for the level of independence in performing activities of daily living.
The purpose of this questionnaire is to assign a score to each patient based on his or her degree of dependence in performing a series of basic activities. The values assigned to each activity depend on the time taken to perform them and the need for aids to complete them.
activity of daily living include: eating, transferring between chair and bed, personal grooming, toileting, bathing/showering, transferring, going up/down stairs, dressing/dressing, stool control and urine control.
The activities are assessed by assigning a score between 0, 5, 10 and 15 points and the final result can vary between 0 (completely dependent) and 100 points (completely independent).
Measured: Up to 7 weeks
Changes in their ability to balance
The Berg balance scale will be used:
A quantitative measure of functional balance status in the elderly that has proven to be a valid, reliable and sensitive tool in hemiplegic patients.
The Berg scale includes 14 items (scored between 0-4) and total scores range from 0 (severe balance impairment) to 56 (optimal balance status).
Measured: Up to 7 weeks
Changes in muscle tone
The modified Ashworth scale for spasticity will be used. A scale used in the clinic to assess muscle spasticity, the modification adds a level that incorporates the angle at which resistance appears and monitors the speed of passive movement with a one-second count.
This scale is easy to use and can assess all joints, has a high degree of reliability and reproducibility. The score is interpreted as follows:
0 No increase in tone
1 slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension.
1+ slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM )
2 more marked increase in tone but more marked increased in muscle tone through most limb easily flexed
3 considerable increase in tone, passive movement difficult
4 limb rigid in flexion or extension
Measured: Up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start24 Apr 2023
- Primary completion24 Jul 2026 (estimated)
- Study completion23 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Las Palmas de Gran Canaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aníbal Báez Suárez, University of Las Palmas de Gran Canaria
- Investigators
- Mariola Lledó Amat, MSc, Principal investigator, University of Las Palmas de Gran Canaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853952
- Sponsor's protocol ID
- NESA ICTUS
- Status last verified
- May 2026
- First submitted
- 21 Apr 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32208842McKevitt 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.
PubMed 21441153Crichton 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.
PubMed 27451353
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Neuromodulation NESA Application in the Rehabilitation of Stroke Sequelae. A Pilot Study
- ClinicalTrials.gov ID
- NCT05853952
- Acronym / sponsor ID
- NESA ICTUS
- Conditions
- Stroke
- Keywords
- physical therapy modality, Electric Stimulation Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Las Palmas de Gran CanariaUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 24 Jul 2026 (estimated)
- Study completion
- 23 Oct 2026 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-invasive Neuromodulation | Experimental | Device: Non-invasive NeuromodulationThe non-invasive neuromodulation experimental group, are treated 20 sessions with the NXSignal non-invasive neuromodulation device (NESA) |
| Placebo Non-invasive Neuromodulation | Placebo comparator | Device: Placebo Non-invasive NeuromodulationThe non-invasive neuromodulation placebo group, are treated 20 sessions with the NXSignal non-invasive neuromodulation device (NESA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive NeuromodulationThe 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 | Device | Non-invasive Neuromodulation |
| Placebo Non-invasive NeuromodulationThe 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. | Device | Placebo Non-invasive Neuromodulation |
Primary outcome
Change in Pain assessed by VAS
Time frame: Up to 7 weeks
The instrument will be used to measure the change of pain before and after the intervention will be the Visual Analogue Scale (VAS). Participants will be asked to mark the level of their pain on a 100 mm, no hatched VAS scale marked at one end as "no pain" and at the other as "worst pain imaginable".
Change in Sleep quality
Time frame: Up to 7 weeks
The Pittsburgh Sleep Quality Index (PSQI) will be used. It consists of 19 self-administered questions and 5 questions assessed by the patient's partner or roommate (if available). Only the self-administered questions are included in the score. The higher the total score, the worse the sleep quality. Thus, a total score less than or equal to five on the Pittsburgh scale indicates that, in general, your sleep quality is optimal, while a total score greater than five suggests that you have sleep problems, of greater or lesser severity.
Changes in quality of life
Time frame: Up to 7 weeks
The Stroke-specific quality of life scale ( ECVI-38) is a specific scale for stroke patients. This instrument includes 38 items divided into eight subgroups: physical status, communication, cognition, emotions, feelings, basic activities of daily living, common activities of daily living and socio-familial functioning. The format presents five response possibilities: 5 represents the worst situation and 1 represents the absence of the problem.
Changes in the level of autonomy
Time frame: Up to 7 weeks
The Barthel index for the level of independence in performing activities of daily living. The purpose of this questionnaire is to assign a score to each patient based on his or her degree of dependence in performing a series of basic activities. The values assigned to each activity depend on the time taken to perform them and the need for aids to complete them. activity of daily living include: eating, transferring between chair and bed, personal grooming, toileting, bathing/showering, transferring, going up/down stairs, dressing/dressing, stool control and urine control. The activities are assessed by assigning a score between 0, 5, 10 and 15 points and the final result can vary between 0 (completely dependent) and 100 points (completely independent).
Changes in their ability to balance
Time frame: Up to 7 weeks
The Berg balance scale will be used: A quantitative measure of functional balance status in the elderly that has proven to be a valid, reliable and sensitive tool in hemiplegic patients. The Berg scale includes 14 items (scored between 0-4) and total scores range from 0 (severe balance impairment) to 56 (optimal balance status).
Changes in muscle tone
Time frame: Up to 7 weeks
The modified Ashworth scale for spasticity will be used. A scale used in the clinic to assess muscle spasticity, the modification adds a level that incorporates the angle at which resistance appears and monitors the speed of passive movement with a one-second count. This scale is easy to use and can assess all joints, has a high degree of reliability and reproducibility. The score is interpreted as follows: 0 No increase in tone 1 slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension. 1+ slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM ) 2 more marked increase in tone but more marked increased in muscle tone through most limb easily flexed 3 considerable increase in tone, passive movement difficult 4 limb rigid in flexion or extension
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Results publication: PubMed 32208842Li 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.
- Results publication: PubMed 21441153McKevitt 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.
- Results publication: PubMed 27451353Crichton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mariola Lledó Amat, MSc principal investigator
University of Las Palmas de Gran Canaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive Neuromodulation in people with Stroke, run by University of Las Palmas de Gran Canaria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariola Lledó Amat, MSc (+34 637 87 68 50, mariola.lledo101@alu.ulpgc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain assessed by VAS (time frame: Up to 7 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05853952, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.