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

January 10, 2025 updated by: Riphah International University

Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Dizziness & Balance in Elderly Population With Vestibular Hypofunction

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Vestibular hypofunction is also known as vestibulopathy or vestibular dysfunction. It may be unilateral affecting one side or a bilateral vestibulopathy having symptoms on both sides.Typically, vestibular dysfunction results in incapacitating symptoms including imbalance, dizziness, and/or oscillopsia. Symptoms of postural instability and unsteadiness of gait, which aggravate in low light and on uneven terrain, may be given by the patient. The symptoms of the patient may go away while they are sitting or lying still. Without any obvious symptoms, it may be quiet Vestibular hypofunction is a common condition among the elderly population and is associated with a high risk of falls and other balance-related problems. Dizziness and balance problems can significantly impact the quality of life of elderly individuals, leading to a loss of independence and increased risk of injury. Cawthorne Cooksey exercise is a well-established and effective rehabilitation program for individuals with vestibular hypofunction. Transcutaneous auricular vagus nerve stimulation has also been shown to have promising effects on balance and dizziness. However, the combined effect of these two interventions has not been extensively studied.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
      • Kashmir, Pakistan
        • ENT dept. of DHQ Mirpur AJK

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Able to give consent
  2. Age 60 and above
  3. Diagnosed patient of unilateral(Left) vestibular hypo function
  4. Both Genders
  5. BBS with 20-41

Exclusion Criteria:

  1. Patient with any neurological impairment (Epilepsy, stroke ALS etc.)
  2. Central cause of vestibular hypo function
  3. History of vestibular neuritis, concussion, head injury or tumor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey
Group will receive intervention of 30 minutes daily for 4 weeks (16 sessions).
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
Active Comparator: Caw Thorne Cooksey
Group will receive intervention of 30 minutes daily for 4 weeks (16 sessions).
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Dix-Hall pike test
Time Frame: 4 weeks
The Dix-Hall pike test is a test used for diagnosis of BPPV. Therapist must be at side of patient and his/her head is rotated to 45 degree & then therapist suddenly lower the patient in supine lying with 30 degrees below horizontal was the neck's extension. First, the right ear is lowered during the manoeuvre, followed by the left ear. Usually accompanied by vertigo, nystagmus is sought after by the therapist. Nystagmus often lasts 10-20 seconds in BPPV and starts a few seconds later. The patient may experience a brief nystagmus in the opposite direction as they are brought back to an upright posture. When testing is repeated, nystagmus and vertigo usually go down. A test is considered positive by reproduction of vertigo and clinician observation of nystagmus
4 weeks
Berg Balance Scale
Time Frame: 4 weeks
It consists of 17 items asking patients to rate their responses to statements related to fear of movement and re injury. It has been widely used among patients with various types of pain and has been translated into several languages. The TSK-17 is a useful tool for assessing kinesiophobia and can aid clinicians in developing appropriate treatment plans for patients who may have fear of movement due to pain or injury (20). The TSK exhibit high level of in- ternal consistency across all items and is positively associated with related measures of fear avoidance, pain catastrophizing, pain related disability. In the Finnish version of TSK the test-retest reliability
4 weeks
The Dizziness Handicap Inventory (DHI)
Time Frame: 4 weeks
The Dizziness Handicap Inventory (DHI) is 25 item self-report questionnaire to asses' vestibular symptom having functional, physical and emotional impact on disability. Patients are asked to answer the questions in Yes, Sometimes and No having 4, 2 and 0 scores. Highest scores are 54+ indicative of severe handicap. Scores b/w 36-52 show moderate and 16-34 means mild handicap.
4 weeks
Dynamic Gait Index (DGI)
Time Frame: 4 weeks
Dynamic Gait Index (DGI) is another test used for walking balance and is helpful in vestibular problem. DGI is 8 item assessment scale which is scored from 0-3 where 0 is indicative of severe impairment and 3 comes to normal performance. It has total of 24 scores where scores 19 or less indicative of increase risk of falls
4 weeks
Modified Clinical Test of sensory interaction & Balance (MCTSIB)
Time Frame: 4 weeks
Modified Clinical Test of sensory interaction & Balance (MCTSIB) is used to asses' sensory contribution to postural control and patients attempt to maintain balance. Patients in standing having hand at sides, feet together and perform 4 sensory items like standing on firm surface with eyes open and then close and then on foam surface with eyes open and close and having time of 30 seconds for each activity
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nadia Azhar, MS-NMPT, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 5, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MUHAMMAD NISAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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