Vestibular DiseasesNCT06303271
Transcutaneous Auricular Vagus Nerve Stimulation on Dizziness & Balance in Elderly Population
A study testing Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey and Caw Thorne Cooksey in people with Vestibular Diseases, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Vestibular Diseases
- What is being tested?
- Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey and Caw Thorne Cooksey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2024to 5 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to give consent
- Age 60 and above
- Diagnosed patient of unilateral(Left) vestibular hypo function
- Both Genders
- BBS with 20-41
Who cannot join
- Patient with any neurological impairment (Epilepsy, stroke ALS etc.)
- Central cause of vestibular hypo function
- History of vestibular neuritis, concussion, head injury or tumor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Being tested
- Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey, Caw Thorne Cooksey
- Keywords
- VNS, Cawthorne exercises
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus Nerve Stimulation (VNS) and Caw Thorne CookseyOther
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 CookseyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey | Experimental | Group will receive intervention of 30 minutes daily for 4 weeks (16 sessions). Receives: 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). Receives: Other: Caw Thorne Cooksey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Feb 2024
- Primary completion5 Jan 2025
- Study completion5 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DiseasesStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia Azhar, MS-NMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303271
- Sponsor's protocol ID
- MUHAMMAD NISAR
- Status last verified
- Jan 2025
- First submitted
- 4 Mar 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Dizziness & Balance in Elderly Population With Vestibular Hypofunction
- ClinicalTrials.gov ID
- NCT06303271
- Acronym / sponsor ID
- MUHAMMAD NISAR
- Conditions
- Vestibular Diseases
- Keywords
- VNS, Cawthorne exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 5 Jan 2025 (actual)
- Study completion
- 5 Jan 2025 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey | Experimental | Other: Vagus Nerve Stimulation (VNS) and Caw Thorne CookseyGroup will receive intervention of 30 minutes daily for 4 weeks (16 sessions). |
| Caw Thorne Cooksey | Active comparator | Other: Caw Thorne CookseyGroup will receive intervention of 30 minutes daily for 4 weeks (16 sessions). |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to give consent
- Age 60 and above
- Diagnosed patient of unilateral(Left) vestibular hypo function
- Both Genders
- BBS with 20-41
Key exclusion criteria (3 listed)
- Patient with any neurological impairment (Epilepsy, stroke ALS etc.)
- Central cause of vestibular hypo function
- History of vestibular neuritis, concussion, head injury or tumor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagus Nerve Stimulation (VNS) and Caw Thorne CookseyStudy 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 | Other | Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey |
| Caw Thorne CookseyStudy 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. | Other | Caw Thorne Cooksey |
Primary outcome
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
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
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia Azhar, MS-NMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey and Caw Thorne Cooksey in people with Vestibular Diseases, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Dix-Hall pike test (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.