NESA Microcurrents on Quality of Life in Geriatric Patients

Aging Clinical Trial

Official title:

Efficiency of NESA Microcurrents on Quality of Life in Geriatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05800431
• Other study ID #: QueeNesa
• Status: Completed
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: April 3, 2024

Study information

• Verified date: April 2024
• Source: University of Las Palmas de Gran Canaria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 3, 2024
• Est. primary completion date: February 27, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging

Intervention

Device:
• Non-invasive neuromodulation through the Nesa device
patients receive non-invasive neurostimulation through the Nesa device

Locations

Country	Name	City	State
Spain	Aníbal Báez Suárez	Las Palmas de Gran Canaria	Palmas, Las

Sponsors (1)

Lead Sponsor	Collaborator
University of Las Palmas de Gran Canaria

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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 D — View Citation

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: 1 — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measurement of change: before treatment (baseline), at two months (end of treatment), and at 6 months of treatment (follow-up period)
Primary	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.	Measurement of change: before treatment (baseline), at two months (end of treatment), and at 6 months of treatment (follow-up period)
Primary	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.	Measurement of change: before treatment (baseline), at two months (end of treatment), and at 6 months of treatment (follow-up period)