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NCT Number: NCT05853952

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mariola Lledó Amat

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

Location status: Recruiting

Location contact

Adolfo Sancho-Francés., PhD

SUB_INVESTIGATOR

Aníbal Báez-Suárez, PhD

SUB_INVESTIGATOR

Mariola Lledó Amat, MSc

CONTACT

[email protected]

+34 637 87 68 50

Raquel Medina-Ramírez, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-invasive Neuromodulation

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

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.

Primary outcomes

  1. 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".

  2. 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.

  3. 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.

  4. 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).

  5. 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).

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mariola Lledó Amat, MSc

CONTACT

[email protected]

+34 637 87 68 50

Sponsors and collaborators

Lead sponsor

University of Las Palmas de Gran Canaria

Other

Registry information

Official study title

Non-invasive Neuromodulation NESA Application in the Rehabilitation of Stroke Sequelae. A Pilot Study

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 11, 2023
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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