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

NCT ID: NCT06303271

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-01-05

Brief 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

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.

Conditions

Vestibular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey

Group will receive intervention of 30 minutes daily for 4 weeks (16 sessions).

Group Type: EXPERIMENTAL

Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey

Intervention Type: OTHER

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

Caw Thorne Cooksey

Group will receive intervention of 30 minutes daily for 4 weeks (16 sessions).

Group Type: ACTIVE_COMPARATOR

Caw Thorne Cooksey

Intervention Type: OTHER

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.

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadia Azhar, MS-NMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

ENT dept. of DHQ Mirpur AJK

Kashmir, , Pakistan

Countries

Pakistan

Other Identifiers

MUHAMMAD NISAR

Identifier Type: -

Identifier Source: org_study_id