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

Not Applicable

Recruiting

• Conditions: Vestibular Hypofunction
• Interventions: Other: Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey; Other: Caw Thorne Cooksey

• Registration Number: NCT06303271
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Study Start: 2024-02-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-08
• Last Update Submitted: 2024-03-08
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey	Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey	Group will receive intervention of 30 minutes daily for 4 weeks (16 sessions).
Caw Thorne Cooksey	Caw Thorne Cooksey	Group will receive intervention of 30 minutes daily for 4 weeks (16 sessions).

Primary Outcome Measures

Name	Time	Method
The Dix-Hall pike test	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
The Dizziness Handicap Inventory (DHI)	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.
Modified Clinical Test of sensory interaction & Balance (MCTSIB)	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
Berg Balance Scale	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
Dynamic Gait Index (DGI)	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

Trial Locations

Locations (1)

ENT dept. of DHQ Mirpur AJK; 🇵🇰 Kashmir, Pakistan