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Transcutaneous Auricular Vagus Nerve Stimulation on Dizziness & Balance in Elderly Population

NCT06303271 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-01-13

No results posted yet for this study

Summary

The objective of the study is to determine the effects of transcutaneous auricular vagus nerve stimulation on dizziness and balance on elderly population with unilateral vestibular hypofunction. Patients will be divided into experimental and control group. Randomized participants will be allocated into control and experimental group. Intervention Group A received Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey exercise while Group group B received Caw Thorne Cooksey exercise only. Both groups received intervention of 30 minutes daily for 4 weeks (16 sessions). Assessment was done at the baseline, after 2 weeks and after 4 weeks

Conditions

  • Vestibular Diseases

Interventions

OTHER

Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey

Study will be conducted after the approval of Ethical review board. After the initial evaluation will be done on participants underlying eligibility criteria. Experimental group will received intervention of 30 minutes daily for 4 weeks (16 sessions). Assessment was done at the baseline, after 2 weeks and after 4 weeks. Intervention Group received non-invasive vagus nerve stimulation at left auricle (because of anatomy of vagus nerve as right VN innervate SA node which is regulating heartbeat and left VN innervates AV node which is responsible for controlling timing of heartbeat) of ear. VNS group received vagus nerve stimulation via Med Fit vagus nerve stimulator at auricle of left ear only as stimulation of right auricular branch of vagus nerve can result in bradycardia. Frequency of stimulation was kept between 15-30Hz. Intensity was gradually increased according to patient's tolerance. The participant was able to withdraw from the trial if he could not tolerate the stimulation

OTHER

Caw Thorne Cooksey

Study will be conducted after the approval of Ethical review board. After the initial evaluation will be done on participants underlying eligibility criteria. The control group will intervention of 30 minutes daily for 4 weeks (16 sessions). Caw Thorne Cooksey exercises were carried out during the stimulation of vagus nerve. Although no adverse effects had been reported during the stimulation of left auricular branch of vagus nerve but a pulse oximeter was used during the stimulation to monitor the heart rate.

Sponsors & Collaborators

  • Riphah International University

    lead OTHER

Principal Investigators

  • Nadia Azhar, MS-NMPT · Riphah International University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2025-01-05
Completion
2025-01-05

Countries

  • Pakistan

Study Locations

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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 NCT06303271 on ClinicalTrials.gov