Non-invasive Neuromodulation NESA Application in the Rehabilitation of Stroke Sequelae
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Las Palmas de Gran Canaria
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Non-invasive Neuromodulation
DeviceThe 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
DeviceThe 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Non-invasive NeuromodulationExperimental treatment 1 intervention
Group B: Placebo Non-invasive NeuromodulationPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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".
Time frame
Up to 7 weeks2
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.
Time frame
Up to 7 weeks3
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.
Time frame
Up to 7 weeks4
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).
Time frame
Up to 7 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov