An interventional study of Transcutaneous Auricular Vagus Nerve Stimulation and Physiotherapy in Frailty Syndrome and Dementia, sponsored by Balnear and Rehabilitation Sanatorium Techirghiol. Completed at 1 site in Romania. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Balnear and Rehabilitation Sanatorium Techirghiol · Not applicable, Interventional, and Prevention
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.
1,198 studies on the registry are indexed under Frailty; 429 are open to participants now.
This study's enrollment of 80 is close to the median of 80 across 680 interventional studies indexed under Frailty.
Browse Frailty studies →Balnear and Rehabilitation Sanatorium Techirghiol is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Age ≥ 60 years.
Exclusion Criteria:
History of major psychiatric disorders, under psychiatric medication or optimal treatment for associated symptoms.
The patients received 1h per day auricular vagus nerve stimulation and individual rehabilitation procedures
Device: Transcutaneous Auricular Vagus Nerve Stimulation · Procedure: Physiotherapy
These patients only received individual rehabilitation procedures
Procedure: Physiotherapy
All patients received individual rehabilitation procedures tailored on their musculoskeletal degenerative disease.
Also known as: Phisiotherapy
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.
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.
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.
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.
Time frame: We performed 2 measurements on day 1 and one on the final day (day 10)
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 1. IL-6: Typically \< 7 pg/mL Values \> 7 pg/mL indicate elevated inflammatory activity 2. Tumor Necrosis Factor Alpha (TNF-α) Typically \< 8 pg/mL 3. 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
Time frame: We performed 2 measurements: on the 1 day and on the final day (day 10)
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Balnear and Rehabilitation Sanatorium Techirghiol