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NESA Microcurrents on Quality of Life in Geriatric Patients

U

University of Las Palmas de Gran Canaria

Status

Completed

Conditions

Aging

Treatments

Device: Non-invasive neuromodulation through the Nesa device

Study type

Interventional

Funder types

Other

Identifiers

NCT05800431
QueeNesa

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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 design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

22 participants in 2 patient groups

Non-invasive Neuromodulation
Experimental group
Description:
The non-invasive neuromodulation experimental group, made up of 20 participants, are treated 20 sessions with the NXSignal non-invasive neuromodulation device (NESA)
Treatment:
Device: Non-invasive neuromodulation through the Nesa device
Control group (CG)
No Intervention group
Description:
Conventional care will be performed without interrupting their normal activity.

Trial contacts and locations

1

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Central trial contact

Aníbal Báez Suárez, PhD

Data sourced from clinicaltrials.gov

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