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

Evaluation of the Transcutaneous Vagal Nerve Stimulation (Auricular Vagal Neuromodulation Therapy) on Cognitive Frailty, Sleep Quality, and Inflammation in Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Frailty Syndrome
• Intervention / Treatment: Device: Transcutaneous Auricular Vagus Nerve Stimulation; Procedure: Physiotherapy

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Constanța County
    • Techirghiol, Constanța County, Romania, 906100
      • Balneal and Rehabilitation Sanatorium Techirghiol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Age ≥ 60 years.

• Vertebro-peripheral osteoarthritic disease without contraindication for physiotherapy
• Patients with cognitive capacity to understand

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aurical Vagus Nerve Stimulated Patients; The patients received 1h per day auricular vagus nerve stimulation and individual rehabilitation procedures	Device: Transcutaneous Auricular Vagus Nerve Stimulation; All patients received individual rehabilitation procedures tailored on their musculoskeletal degenerative disease.; Other Names: Phisiotherapy; Procedure: Physiotherapy; 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.
Sham Comparator: Sham Group - Non stimulated patients; These patients only received individual rehabilitation procedures	Procedure: Physiotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of AVNT (Trans-auricular vagus nerve stimulation) therapy on sleep quality	We used the Pittsburgh Sleep Quality Index (PSQI) to asses the quality of sleep. Scoring - units per scale Total score range: 0-21 Score ≤ 5: Good sleep quality Score > 5: Poor sleep quality Higher scores indicate worse sleep quality. The PSQI evaluates 7 components: Subjective sleep quality, Sleep latency, Sleep duration, Habitual sleep efficiency, Sleep disturbances, Use of sleep medication, Daytime dysfunction. In this study, both total PSQI score and component-level changes were analyzed.	We performed 2 measurements on day 1 and one on the final day (day 10)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effects of AVNT (trans-auricular vagus nerve stimulation) therapy on inflammation	We will assess quantitative C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), interleukin-6 (IL-6), and tumor necrosis factor alpha (TNF-α). Reference Range and measurement unit; IL-6: Typically < 7 pg/mL Values > 7 pg/mL indicate elevated inflammatory activity; Tumor Necrosis Factor Alpha (TNF-α) Typically < 8 pg/mL; Quantitative C-reactive protein (CRP) < 5 mg/L: Normal 5-10 mg/L: Mild inflammation 10 mg/L: Significant inflammation (acute or chronic) 4. Erythrocyte Sedimentation Rate (ESR) For men: < 20 mm/hour For women: < 30 mm/hour	We performed 2 measurements: on the 1 day and on the final day (day 10)

Collaborators and Investigators

• Sponsor: Balnear and Rehabilitation Sanatorium Techirghiol

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): May 15, 2025

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Pathologic Processes; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Frailty; Dementia; Therapeutics; Rehabilitation; Physical Therapy Modalities
• Other Study ID Numbers: AmaliaVancea

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No