Clinical trial NCT06303271: Transcutaneous Auricular Vagus Nerve Stimulation on Dizziness & Balance in Elderly Population
Official title: Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Dizziness & Balance in Elderly Population With Vestibular Hypofunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Diseases
Keywords: VNS, Cawthorne exercises
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Dix-Hall pike test
timeFrame: 4 weeks
measure: Berg Balance Scale
timeFrame: 4 weeks
measure: The Dizziness Handicap Inventory (DHI)
timeFrame: 4 weeks
measure: Dynamic Gait Index (DGI)
timeFrame: 4 weeks
measure: Modified Clinical Test of sensory interaction & Balance (MCTSIB)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kashmir
country: Pakistan
facility: ENT dept. of DHQ Mirpur AJK
Study officials:
affiliation: Riphah International University
name: Nadia Azhar, MS-NMPT
role: PRINCIPAL_INVESTIGATOR
References: