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

NCT07416708 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-04

No results posted yet for this study

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

Interventions

DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation

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

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.

Sponsors & Collaborators

  • Balnear and Rehabilitation Sanatorium Techirghiol

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-05-01
Completion
2025-05-15

Countries

  • Romania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07416708 on ClinicalTrials.gov