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AgingNCT05800431

NESA Microcurrents on Quality of Life in Geriatric Patients

A study testing Non-invasive neuromodulation through the Nesa device in people with Aging, run by University of Las Palmas de Gran Canaria at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In recent years, the population of older adults (MA) in the world has been increasing, due to the increase in life expectancy and the decrease in the fertility rate. The United Nations (UN) places Spain as the most aged country in the world in the year 2050, with 40% of its population over 60 years of age. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Non-invasive neuromodulation through the Nesa device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteSpain
Study dates
1 Aug 2023to 3 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Patients residing in the social-health care center under study.
  • Stable medical and pharmacological condition.
  • No cognitive impairment or mild cognitive impairment.

Who cannot join

  • Patients with some of the contraindications for treatment with NESA device: pacemakers, internal bleeding, not applying electrodes on skin in poor condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and/or phobia of electricity,
  • Not having signed the informed consent form.
  • Patients with severe cognitive impairment, patients with severe cognitive impairment.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Aníbal Báez Suárez

    Las Palmas de Gran Canaria, Spain, 35018

Other trials in Spain

About this study

Official title: Efficiency of NESA Microcurrents on Quality of Life in Geriatric Patients

In recent years, the population of older adults (MA) in the world has been increasing, due to the increase in life expectancy and the decrease in the fertility rate. The United Nations (UN) places Spain as the most aged country in the world in the year 2050, with 40% of its population over 60 years of age. There is evidence that quality of life in the elderly is associated with variables linked to physical and psychological health. Thus, for example, previous research indicates that perceived health and cognitive functioning influence the perception of quality of life.

The NESA XSIGNAL® device is a low-frequency, non-invasive neuromodulation device that uses microcurrents to restore electrical balance in the body. This technology is approved as medical equipment and is CE marked.

This non-invasive neuromodulation equipment is starting to have promising results in patients with sleep disorders. So it can be a useful tool to reduce the impact on the geriatric patient's quality of life.

Read the detailed description

The main objective will be to evaluate the efficacy of the application of non-invasive neuromodulation in the treatment of geriatric patients for the improvement of health-related quality of life. For this purpose, the investigators propose to carry out an interventional study with a sample of approximately 40 participants. Data will be recorded for 1 month and a half for each participant.

It is estimated 7 months from the design, management and development of the project, and it does not have sources of financing.

Conditions
Aging
Being tested
Non-invasive neuromodulation through the Nesa device
Keywords
physical therapy modality, sleep disorders, Quality of Life
Medical subject headings
Sleep Wake Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-invasive neuromodulation through the Nesa deviceDevice

    patients receive non-invasive neurostimulation through the Nesa device

Study groups in NCT05800431
Study groupRoleWhat they receive
Non-invasive NeuromodulationExperimentalThe non-invasive neuromodulation experimental group, made up of 20 participants, are treated 20 sessions with the NXSignal non-invasive neuromodulation device (NESA)
Receives: Device: Non-invasive neuromodulation through the Nesa device
Control group (CG)No interventionConventional care will be performed without interrupting their normal activity.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in sleep quality

    The investigators want to see if there are improvements in the quality, efficiency, and quantity of sleep. The Pittsburgh Sleep Quality Index (PSQI) will be combined to report changes in the patient's sleep quality.

    Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.

    Adding up the average scores of the seven factors gives a global PSQI score from 0 to 21, with 0-4 indicating "good" sleep and 5-21 indicating "poor" sleep

    Measured: Measurement of change: before treatment (baseline), at two months (end of treatment), and at 6 months of treatment (follow-up period)

  2. Change in quality of life

    The investigators want to see if the quality of life of patients improves when their relatives receive treatment. The Spanish version of the World Health Organization Quality of Life of Older Adults (WHOQOL-OLD) scale will be used.

    The WHOQOL-OLD is made up of 24 Likert-type scale items divided into six areas Likert-type scale, divided into six areas: sensory skills, autonomy, past activities abilities, autonomy, past, present and future activities, social participation, death and intimacy. Each of these areas contains four items, with a final score ranging from 4 to 20, provided that all items in the same area have been completed. The higher the score, the better the quality of life in each area.

    Measured: Measurement of change: before treatment (baseline), at two months (end of treatment), and at 6 months of treatment (follow-up period)

  3. Changes in mood

    The investigators will use the Geriatric Depression Scale (GDS).

    This is a questionnaire for screening for depression in people over 65 years of age. The main caregiver must answer 15 questions, one point is assigned for each answer that matches the one reflected on the side (affirming depression). The cut-off points are:

    • normal: 0 to 5 points
    • moderate depression: 6 to 10 points;
    • severe depression: more than 10 points.

    Measured: Measurement of change: before treatment (baseline), at two months (end of treatment), and at 6 months of treatment (follow-up period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2023
  2. Study start1 Aug 2023
  3. Primary completion27 Feb 2024
  4. Study completion3 Apr 2024

Resources

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
Non-randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05800431
Sponsor's protocol ID
QueeNesa
Status last verified
Apr 2024
First submitted
17 Mar 2023
Last updated
27 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ogawa T, Koike M. Independent factors that attenuate the effectiveness of fracture rehabilitation in improving activities of daily living in female patients aged 80 years and above. Aging Clin Exp Res. 2022 Apr;34(4):793-800. doi: 10.1007/s40520-021-01992-y. Epub 2021 Oct 8.

    PubMed 34623628

  • Gottschalk S, Konig HH, Schwenk M, Nerz C, Becker C, Klenk J, Jansen CP, Dams J. Cost-Effectiveness of a Group vs Individually Delivered Exercise Program in Community-Dwelling Persons Aged >/=70 Years. J Am Med Dir Assoc. 2022 May;23(5):736-742.e6. doi: 10.1016/j.jamda.2021.08.041. Epub 2021 Oct 7.

    PubMed 34626579

  • Tang T, Jiang J, Tang X. Psychological risk and protective factors associated with depression among older adults in mainland China: A systematic review and meta-analysis. Int J Geriatr Psychiatry. 2022 Jan;37(1). doi: 10.1002/gps.5637. Epub 2021 Oct 14.

    PubMed 34633701

  • Coin A, Devita M, Trevisan C, Biasin F, Terziotti C, Signore SD, Fumagalli S, Gareri P, Malara A, Mossello E, Volpato S, Monzani F, Bellelli G, Zia G, Ranhoff AH, Antonelli Incalzi R. Psychological Well-Being of Older Adults With Cognitive Deterioration During Quarantine: Preliminary Results From the GeroCovid Initiative. Front Med (Lausanne). 2021 Sep 22;8:715294. doi: 10.3389/fmed.2021.715294. eCollection 2021.

    PubMed 34631737

Questions about this trial

What is this clinical trial studying?

A study testing Non-invasive neuromodulation through the Nesa device in people with Aging, 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 3 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: finished, as of the sponsor's last update on 27 Mar 2025. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in sleep quality (time frame: Measurement of change: before treatment (baseline), at two months (end of treatment), and at 6 months of treatment (follow-up period)). The study lists 3 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 NCT05800431, which also lists 4 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 27 Mar 2025.

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