Dizziness ChronicNCT02048670

Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness

A study testing Balance Belt in people with Dizziness Chronic, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Researchers are gathering information on the safety and effectiveness of a new device called the BalanceBelt. Read more about this study

Who is it for?: Ages 25 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Dizziness Chronic
What is being tested?: Balance Belt
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Oct 2014to Jul 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 25 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects will be 25-70 years of age inclusive and pregnant women may participate.
Patients will have CSD as their primary diagnosis for the cause of their balance and dizziness complaints provided by the Behavioral Medicine Program for Dizziness, a division of the Department of Psychiatry \& Psychology.
Normal volunteers will have a negative history of otologic \& neurologic disorders and no history of dizziness and balance problems.
Normal volunteers will have normal findings on a screening office examination for peripheral and central vestibular system involvement (see methods for details of the examination) and screening for normal or symmetrical hearing loss of explainable origin.

Who cannot join

Patients with positive indications from testing of peripheral and/or central vestibular system involvement that is felt to be influencing the symptoms reported beyond the CSD alone.
Patients with mobility restriction that would prevent participating in the tests or the intensive therapy trials.
Subjects with hearing impairment that interferes with oral communication.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Pilot Project to Investigate the Use of an External Vestibular Prosthesis Potential to Improve Clinical Management of Chronic Subjective Dizziness (CSD)

Researchers are gathering information on the safety and effectiveness of a new device called the BalanceBelt.

Read the detailed description

Ten consecutive subjects, ages 25-70 years, diagnosed with Chronic Subjective Dizziness (CDS) and ten healthy age and gender matched subjects will be asked to perform tests involving walking and balance while wearing the BalanceBelt. The BalanceBelt is a lightweight belt that will be worn under the clothes around the subjects waist and uses sensitive motion detectors and vibrates against the skin at four locations to provide information about posture and motion.

Conditions: Dizziness Chronic
Being tested: Balance Belt
Keywords: Pilot study, Assessment of sway phase, Therapy trial phase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Balance BeltDevice
Also called Stabalon Belt, Vibrating Belt
Vestibular habituation therapy worn under the clothes around the waist that uses sensitive motion detectors and vibrates against the skin at four locations to provide information about posture and gait

Study groups in NCT02048670
Study group	Role	What they receive
Chronic Subjective Dizziness Syndrome Subjects	Experimental	Subjects diagnosed with Chronic Subjective Dizziness Syndrome (CDS) will wear the BalanceBelt while performing test involving walking and balance. Receives: Device: Balance Belt
Healthy Subjects	Active comparator	Age matched healthy subjects without complaints of balance or dizziness problems will wear the BalanceBelt while performing test involving walking and balance. Receives: Device: Balance Belt

What is being measured

The primary outcome is the main question the study is designed to answer.

Degrees of Sway
The Sensory Organization Test is a six condition standard evaluation of balance control performed on a dynamic platform that can record sway movement in the A/P dimension while the sensory inputs from proprioception and vision are varied though the platform and visual surround movements. Condition 1 - eyes open, visual locked, platform locked. Condition 2 - eyes closed, visual locked, platform locked. Condition 3 - eyes open, visual unlocked, platform locked. Condition 4 - eyes open, visual locked, platform unlocked. Condition 5 - eyes closed, visual locked, platform unlocked. Condition 6 - eyes open, visual unlocked, platform unlocked. All participants progress though the exam, starting with condition 1 and ending with condition 6. All conditions were completed two to three times depending on performance with the average of each condition reported.
Measured: baseline

Secondary outcomes (1)

Visual Analog Scales Score
For the therapy portion of the study aim #2 Visual Analog Scales (VAS) related to the intensity of symptoms provoked by visual motion, head movements and walking in visually complex environments. The average Visual Analog Scale scores for the patient group pre and post therapy will be compared for any significant difference in the score (p<0.05). The VAS ranges from 0-10, where 0 is no symptoms and 10 is the most intense symptoms experienced.
Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Jul 2017

First posted29 Jan 2014 (estimated)
Study startOct 2014
Primary completionJul 2017
Study completionJul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dizziness ChronicStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02048670
Sponsor's protocol ID: 13-005525
Status last verified: Apr 2019
First submitted: 22 Jan 2014
Last updated: 15 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingEarly Phase 1
Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness
Persistent Postural Perceptual Dizziness, Vestibular Migraine
Enrolling by invitation
A Study Of Auricular Transcutaneous Vagus Nerve Stimulation In Chronic Dizziness
Chronic Dizziness, Persistent Postural Perceptual Dizziness
Recruiting
Effect of Mental Imagery in Patients With Persistent Post-concussion Symptoms
Mild Traumatic Brain Injury, Concussion, Post Concussive Syndrome, Chronic
RecruitingPhase 2
Personalized Brain Stimulation to Treat Chronic Concussive Symptoms
Post-Concussion Syndrome, Concussion, Brain
Not yet recruiting
Comparison Between Traditional Vestibular Rehabilitation Therapy And Virtual Reality In Management Of Patients With Chronic Dizziness
Chronic Dizziness

All Dizziness Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Project to Investigate the Use of an External Vestibular Prosthesis Potential to Improve Clinical Management of Chronic Subjective Dizziness (CSD)
ClinicalTrials.gov ID: NCT02048670
Acronym / sponsor ID: 13-005525
Conditions: Dizziness Chronic
Keywords: Pilot study, Assessment of sway phase, Therapy trial phase
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: Oct 2014
Primary completion: Jul 2017 (actual)
Study completion: Jul 2017 (actual)
First posted: 29 Jan 2014 (estimated)
Results: Posted 15 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Researchers are gathering information on the safety and effectiveness of a new device called the BalanceBelt.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Chronic Subjective Dizziness Syndrome Subjects	Experimental	Device: Balance BeltSubjects diagnosed with Chronic Subjective Dizziness Syndrome (CDS) will wear the BalanceBelt while performing test involving walking and balance.
Healthy Subjects	Active comparator	Device: Balance BeltAge matched healthy subjects without complaints of balance or dizziness problems will wear the BalanceBelt while performing test involving walking and balance.

Who may qualify

Ages: 25 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subjects will be 25-70 years of age inclusive and pregnant women may participate.
Patients will have CSD as their primary diagnosis for the cause of their balance and dizziness complaints provided by the Behavioral Medicine Program for Dizziness, a division of the Department of Psychiatry \& Psychology.
Normal volunteers will have a negative history of otologic \& neurologic disorders and no history of dizziness and balance problems.
Normal volunteers will have normal findings on a screening office examination for peripheral and central vestibular system involvement (see methods for details of the examination) and screening for normal or symmetrical hearing loss of explainable origin.

Key exclusion criteria (3 listed)

Patients with positive indications from testing of peripheral and/or central vestibular system involvement that is felt to be influencing the symptoms reported beyond the CSD alone.
Patients with mobility restriction that would prevent participating in the tests or the intensive therapy trials.
Subjects with hearing impairment that interferes with oral communication.

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
Balance BeltAlso: Stabalon Belt, Vibrating BeltVestibular habituation therapy worn under the clothes around the waist that uses sensitive motion detectors and vibrates against the skin at four locations to provide information about posture and gait	Device	Chronic Subjective Dizziness Syndrome Subjects, Healthy Subjects

Primary outcome

Degrees of Sway
Time frame: baseline
The Sensory Organization Test is a six condition standard evaluation of balance control performed on a dynamic platform that can record sway movement in the A/P dimension while the sensory inputs from proprioception and vision are varied though the platform and visual surround movements. Condition 1 - eyes open, visual locked, platform locked. Condition 2 - eyes closed, visual locked, platform locked. Condition 3 - eyes open, visual unlocked, platform locked. Condition 4 - eyes open, visual locked, platform unlocked. Condition 5 - eyes closed, visual locked, platform unlocked. Condition 6 - eyes open, visual unlocked, platform unlocked. All participants progress though the exam, starting with condition 1 and ending with condition 6. All conditions were completed two to three times depending on performance with the average of each condition reported.

1 secondary outcome

Visual Analog Scales Score
Time frame: baseline

Results and safety

Results posted to the registry on 15 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chronic Subjective Dizziness Syndrome Subjects	6	6
Healthy Subjects	6	6

Primary outcome: Degrees of Sway

Time frame: baseline. Mean (Standard Error). Unit: degrees of sway

Measure	Chronic Subjective Dizziness Syndrome Subjects n = 6	Healthy Subjects n = 6
Condition 1	1.824 (0.266)	0.746 (0.278)
Condition 2	1.638 (0.259)	0.573 (0.287)
Condition 3	1.605 (0.252)	0.869 (0.278)
Condition 4	1.480 (0.259)	1.979 (0.259)
Condition 5	1.900 (0.270)	1.892 (0.278)
Condition 6	1.519 (0.274)	2.666 (0.274)

Chronic Subjective Dizziness Syndrome Subjects vs Healthy Subjects: p = 0.005, Kruskal-Wallis
Chronic Subjective Dizziness Syndrome Subjects vs Healthy Subjects: p = 0.006, Kruskal-Wallis
Chronic Subjective Dizziness Syndrome Subjects vs Healthy Subjects: p = 0.051, Kruskal-Wallis

1 secondary outcome is reported in the full results.

Adverse events

Time frame: For this study, adverse events will be captured and reported from enrollment to the end of the study treatment for each subject, approximately one day.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chronic Subjective Dizziness Syndrome Subjects	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Healthy Subjects	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Dizziness Chronic

RecruitingEarly Phase 1
Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness
Persistent Postural Perceptual Dizziness, Vestibular Migraine
Enrolling by invitation
A Study Of Auricular Transcutaneous Vagus Nerve Stimulation In Chronic Dizziness
Chronic Dizziness, Persistent Postural Perceptual Dizziness
Recruiting
Effect of Mental Imagery in Patients With Persistent Post-concussion Symptoms
Mild Traumatic Brain Injury, Concussion, Post Concussive Syndrome, Chronic
RecruitingPhase 2
Personalized Brain Stimulation to Treat Chronic Concussive Symptoms
Post-Concussion Syndrome, Concussion, Brain
Not yet recruiting
Comparison Between Traditional Vestibular Rehabilitation Therapy And Virtual Reality In Management Of Patients With Chronic Dizziness
Chronic Dizziness

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.

Jeffrey Staab, MD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Balance Belt in people with Dizziness Chronic, run by Mayo Clinic at 1 site in United States.

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 4 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 15 May 2019. 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 United States. 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?

Yes. Results are posted in the registry (first posted 15 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Degrees of Sway (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02048670.

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 15 May 2019.