Vestibular DiseasesPhase 1NCT00146952
Use of a Vibrotactile Sensory Prosthesis in Patients With Postural Imbalance and Spatial Disorientation
A Phase 1 study testing Vibrotactile feedback in people with Vestibular Diseases and Peripheral Neuropathies, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The investigators propose to explore the hypothesis that vibrotactile channels for indicating spatial orientation can be exploited as a sensory prosthesis. The specific research applications will be used for guiding visual orientation, to provide alternative feedback to vision and vestibular signals for controlling… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Diseases, Peripheral Neuropathies, Proprioceptive Disorders
- What is being tested?
- Vibrotactile feedback
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2005to Dec 2007
- Phase
- Phase 1
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sensory impairments
- Unsteadiness
Who cannot join
- High strokes
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Charing Cross Hospital
London, W6 8RF
Michael A Gresty, Pr, 020-8846 ext. 7634, m.gresty@imperial.ac.uk
Francois B Asseman, Dr, 020-8383 ext. 5525, f.asseman@imperial.ac.uk
About this study
Official title: Evaluation of a Vibrotactile Sensory Aid Developed by the US Navy to Combat Pilot Disorientation as a Prosthesis in Patients With Postural Imbalance and Spatial Disorientation
The investigators propose to explore the hypothesis that vibrotactile channels for indicating spatial orientation can be exploited as a sensory prosthesis. The specific research applications will be used for guiding visual orientation, to provide alternative feedback to vision and vestibular signals for controlling balance, and for directional and lateralisation cueing in patients with neglect syndromes. The programme will study whether vibrotactile feedback improves performance and also if it speeds rehabilitation when used as an adjunct to conventional therapy.
- Conditions
- Vestibular Diseases, Peripheral Neuropathies, Proprioceptive Disorders, Hemispatial Neglect
- Being tested
- Vibrotactile feedback
- Keywords
- Hemineglects
- Medical subject headings
- Vestibular Diseases, Peripheral Nervous System Diseases, Somatosensory Disorders, Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrotactile feedbackDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean time reaction to the perturbation with the feedback
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startJan 2005
- Study completionDec 2007
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 Imperial College LondonThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Investigators
- Michael A Gresty, Pr, Principal investigator, Imperial College LondonAdolfo M Bronstein, Pr, MD, Study director, Imperial College LondonChristopher Kennard, Pr, MD, Study director, Imperial College LondonMasud Husain, Dr, Study director, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146952
- Sponsor's protocol ID
- DNMCA-PR1077
- Status last verified
- Sep 2005
- First submitted
- 5 Sep 2005
- Last updated
- 11 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Vibrotactile Sensory Aid Developed by the US Navy to Combat Pilot Disorientation as a Prosthesis in Patients With Postural Imbalance and Spatial Disorientation
- ClinicalTrials.gov ID
- NCT00146952
- Acronym / sponsor ID
- DNMCA-PR1077
- Conditions
- Vestibular Diseases, Peripheral Neuropathies, Proprioceptive Disorders, Hemispatial Neglect
- Keywords
- Hemineglects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- Jan 2005
- Study completion
- Dec 2007
- First posted
- 7 Sep 2005 (estimated)
- 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 investigators propose to explore the hypothesis that vibrotactile channels for indicating spatial orientation can be exploited as a sensory prosthesis. The specific research applications will be used for guiding visual orientation, to provide alternative feedback to vision and vestibular signals for controlling balance, and for directional and lateralisation cueing in patients with neglect syndromes. The programme will study whether vibrotactile feedback improves performance and also if it speeds rehabilitation when used as an adjunct to conventional therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sensory impairments
- Unsteadiness
Key exclusion criteria (1 listed)
- High strokes
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 |
|---|---|---|
| Vibrotactile feedback | Device | – |
Primary outcome
Mean time reaction to the perturbation with the feedback
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
- Related InfoLink provided by the sponsor.
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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.
Michael A Gresty, Pr principal investigator
Imperial College London
Adolfo M Bronstein, Pr, MD study director
Imperial College London
Christopher Kennard, Pr, MD study director
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vibrotactile feedback in people with Vestibular Diseases and Peripheral Neuropathies, run by Imperial College London at 1 site in United Kingdom.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Nov 2016. 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 Kingdom. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael A Gresty, Pr (020-8846 ext. 7634, m.gresty@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean time reaction to the perturbation with the feedback. 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 11 Nov 2016.