The Impact of Transcutaneous Vagal Nerve Stimulation on Frailty Syndrome in Older Adults

NCT07416708 | Completed

• 1 other identifier: AmaliaVancea
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study, conducted at the Techirghiol Balneary and Rehabilitation Sanatorium, aims to evaluate the effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) in improving clinical and biological parameters associated with frailty in older adults. Over a two-week period, participants aged over 60 years, without dementia, cardiac pacemakers, or auditory implants, will be assigned to two groups: an intervention group receiving active taVNS and a control group receiving sham stimulation. Both groups will undergo individualized medical rehabilitation therapies according to their clinical needs. The study will assess frailty using the Edmonton Frailty Scale, sleep quality through the Pittsburgh Sleep Quality Index, and cognitive function with the Montreal Cognitive Assessment (MoCA) and the Rapid Cognitive Screen. Additionally, inflammatory markers (C-reactive protein, IL-6, TNF-alpha) will be measured at baseline and upon discharge. The primary objective is to demonstrate that the intervention group will show greater improvements in cognitive scores, sleep quality, and reductions in inflammatory markers compared to the control group at the end of the study.

Conditions

Frailty Syndrome; Dementia

Outcome Measures

Primary Outcomes (1)

• Evaluation of the transcutaneous vagal nerve stimulation (Auricular Vagal Neuromodulation Therapy) on Cognitive Frailty

  Investigation of AVNT effect on cognitive frailty using the Montreal Cognitive Assessment (MoCA-B), Edmonton Frailty Scale, and Rapid Cognitive Screen Test (RCS). Every one of the test is measured in units of a scale. For Montreal Cognitive Assessment - Basic (MoCA-B) the total Score is 30 points. A score ≥ 26 is generally considered within normal limits Scores \< 26 may suggest mild cognitive impairment (MCI). \< 20 may suggest moderate cognitive impairment. In this study, we calculated both the total MoCA-B score and separate domain-specific scores to identify domain-level changes more precisely. The Rapid Cognitive Test is a brief screening instrument used to detect mild cognitive impairment and early dementia. Maximum score:10 ; ≤5: Suggestive of dementia For the Edmonton Frail Scale (EFS), the scoring system is: Total score range: 0-17; Higher scores indicate greater frailty. It was administered only at baseline (upon admission) as a reference measure of frailty status.

  From enrollment to the end of treatment at 10 days - MOCA-B and RCS test The Edmonton Frailty Scale was only used at admission as a reference measure of frailty status because meaningful changes in frailty status typically require longer time intervals.

Secondary Outcomes (1)

• Effects of AVNT (Trans-auricular vagus nerve stimulation) therapy on sleep quality

  We performed 2 measurements on day 1 and one on the final day (day 10)

Other Outcomes (1)

• The effects of AVNT (trans-auricular vagus nerve stimulation) therapy on inflammation

  We performed 2 measurements: on the 1 day and on the final day (day 10)

Study Arms (2)

Aurical Vagus Nerve Stimulated Patients

EXPERIMENTAL

The patients received 1h per day auricular vagus nerve stimulation and individual rehabilitation procedures

Device: Transcutaneous Auricular Vagus Nerve Stimulation; Procedure: Physiotherapy

Sham Group - Non stimulated patients

SHAM COMPARATOR

These patients only received individual rehabilitation procedures

Procedure: Physiotherapy

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation DEVICE

All patients received individual rehabilitation procedures tailored on their musculoskeletal degenerative disease.

Also known as: Phisiotherapy

Aurical Vagus Nerve Stimulated Patients

Physiotherapy PROCEDURE

Physiotherapy is a non-invasive treatment used to relieve pain, improve mobility, and speed up recovery after injuries, surgeries, or chronic conditions. It helps restore body functions, improve posture, and prevent relapses.

Aurical Vagus Nerve Stimulated Patients; Sham Group - Non stimulated patients

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 60 years.
• Vertebro-peripheral osteoarthritic disease without contraindication for physiotherapy
• Patients with cognitive capacity to understand

You may not qualify if:

• History of major psychiatric disorders, under psychiatric medication or optimal treatment for associated symptoms.
• Long-term use of corticosteroid or nonsteroidal anti-inflammatory drugs up to one month before the study
• Sedative medication during hospitalization.
• Allergies or sensitivities to electrodes or the Nurosym device.

Sponsors & Collaborators

• Balnear and Rehabilitation Sanatorium Techirghiol: lead

Study Sites (1)

Balneal and Rehabilitation Sanatorium Techirghiol

Techirghiol, Constanța County, 906100, Romania

Location

MeSH Terms

Conditions

Frailty; Dementia

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assit. Prof. Dr. Ionescu Elena Valentina

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 18, 2026
• Study Start: December 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 15, 2025
• Last Updated: March 4, 2026

Record last verified: 2024-12

Locations

RO (1)