Dementia, Frailty Syndrome
Conditions
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.
Interventions
DEVICETranscutaneous Auricular Vagus Nerve Stimulation
All patients received individual rehabilitation procedures tailored on their musculoskeletal degenerative disease.
PROCEDUREPhysiotherapy
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.
Sponsors
Balnear and Rehabilitation Sanatorium Techirghiol
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the transcutaneous vagal nerve stimulation (Auricular Vagal Neuromodulation Therapy) on Cognitive Frailty | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
Countries
Romania
Outcome results
None listed