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Completed

NCT Number: NCT07416708

The Impact of Transcutaneous Vagal Nerve Stimulation on Frailty Syndrome 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.

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Key information

Conditions

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

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Balneal and Rehabilitation Sanatorium Techirghiol

Techirghiol, Constanța County, 906100, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcutaneous Auricular Vagus Nerve Stimulation

Device

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

Other names: Phisiotherapy

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.

Primary outcomes

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

    Time frame: 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.

    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.

Secondary outcomes

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

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

    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.

Other outcomes

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

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

    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)

    • Erythrocyte Sedimentation Rate (ESR) For men: < 20 mm/hour For women: < 30 mm/hour

Sponsors and collaborators

Lead sponsor

Balnear and Rehabilitation Sanatorium Techirghiol

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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