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

NCT06303271 | Completed

• 1 other identifier: MUHAMMAD NISAR
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Vestibular Diseases

Keywords

VNS, Cawthorne exercises

Outcome Measures

Primary Outcomes (5)

• The Dix-Hall pike test

  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

  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)

  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)

  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)

  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

Study Arms (2)

Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey

EXPERIMENTAL

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

Other: Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey

Caw Thorne Cooksey

ACTIVE COMPARATOR

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

Other: Caw Thorne Cooksey

Interventions

Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey 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

Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey

Caw Thorne Cooksey 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.

Caw Thorne Cooksey

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to give consent
• Age 60 and above
• Diagnosed patient of unilateral(Left) vestibular hypo function
• Both Genders
• BBS with 20-41

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

ENT dept. of DHQ Mirpur AJK

Kashmir, Pakistan

Location

MeSH Terms

Conditions

Vestibular Diseases

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Nadia Azhar, MS-NMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: February 1, 2024
• Primary Completion: January 5, 2025
• Study Completion: January 5, 2025
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)