Hemispatial NeglectNCT00271388
Vestibular Stimulation to Treat Hemispatial Neglect
A study testing Transcutaneous current to the vestibular nerve in people with Hemispatial Neglect and Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of the current proposal is to pilot a new and potentially improved treatment for neglect. The procedure involves the delivery of transcutaneous small-amplitude current to the vestibular nerves that lie directly below the mastoid bones. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemispatial Neglect, Stroke
- What is being tested?
- Transcutaneous current to the vestibular nerve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 2008
- 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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants must be literate in English
- Right handed
- Have corrected near-visual acuity of 20/40 or better
- Patients must also have a minimum of twelve years education
- These inclusionary criteria are based on the data of both Black, Yu, Martin, and Szalai (90) and our own studies.
- They are intended to assure that only patients with sufficiently severe symptoms will be admitted to our study.
Who cannot join
- Exclusionary criteria include:
- Homonymous hemianopia
- Presence of a severe field cut extending toward the midline on formal perimetry (however many patients who have field cuts restricted to the periphery will be able to fully perceive our stimulus displays so can be included
- Evidence of aphasia on clinical examination (crossed aphasia)
- A significant history of other neurological or psychiatric illness or drug/alcohol abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, 02130
About this study
Official title: Noise Enhanced Galvanic Vestibular Stimulation in Hemispatial Neglect
The purpose of the current proposal is to pilot a new and potentially improved treatment for neglect. The procedure involves the delivery of transcutaneous small-amplitude current to the vestibular nerves that lie directly below the mastoid bones.
Read the detailed description
The purpose of the current proposal is to pilot a new and potentially improved treatment for neglect. The procedure involves the delivery of transcutaneous small-amplitude current to the vestibular nerves that lie directly below the mastoid bones. With the intention of boosting activity in the damaged left hemisphere, positive and negative current is delivered to the left and right mastoids respectively. While successfully used to rehabilitate gait and balance disorders, the procedure has only once been applied to neglect.
In the present investigation, we will first confirm and then optimize the conditions under which galvanic vestibular stimulation (GVS) ameliorates neglect. This in turn will justify subsequent work (in a later funding cycle) that will demonstrate the safety and efficacy of the treatment on a much larger clinical scale, and merit the construction of a miniaturized portable device.
- Conditions
- Hemispatial Neglect, Stroke
- Being tested
- Transcutaneous current to the vestibular nerve
- Keywords
- Galvanic Vestibular Stimulation, Hemispatial Neglect, Stroke
- Medical subject headings
- Perceptual Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous current to the vestibular nerveDevice
Delivery of randomly oscillating low level current
| Study group | Role | What they receive |
|---|---|---|
| Parameter Determination | Experimental | Testing potential effects of GVS on the symptoms of neglect Receives: Device: Transcutaneous current to the vestibular nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of Hemispatial Neglect
Improvement of Hemispatial neglect
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2005 (estimated)
- Study startJan 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemispatial NeglectStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- William Milberg, PhD, Principal investigator, VA Medical Center, Jamaica Plain Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271388
- Sponsor's protocol ID
- C3868-R
- Status last verified
- Jun 2018
- First submitted
- 28 Dec 2005
- Last updated
- 6 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noise Enhanced Galvanic Vestibular Stimulation in Hemispatial Neglect
- ClinicalTrials.gov ID
- NCT00271388
- Acronym / sponsor ID
- C3868-R
- Conditions
- Hemispatial Neglect, Stroke
- Keywords
- Galvanic Vestibular Stimulation, Hemispatial Neglect, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jan 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 30 Dec 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 purpose of the current proposal is to pilot a new and potentially improved treatment for neglect. The procedure involves the delivery of transcutaneous small-amplitude current to the vestibular nerves that lie directly below the mastoid bones.
Detailed description
The purpose of the current proposal is to pilot a new and potentially improved treatment for neglect. The procedure involves the delivery of transcutaneous small-amplitude current to the vestibular nerves that lie directly below the mastoid bones. With the intention of boosting activity in the damaged left hemisphere, positive and negative current is delivered to the left and right mastoids respectively. While successfully used to rehabilitate gait and balance disorders, the procedure has only once been applied to neglect.
In the present investigation, we will first confirm and then optimize the conditions under which galvanic vestibular stimulation (GVS) ameliorates neglect. This in turn will justify subsequent work (in a later funding cycle) that will demonstrate the safety and efficacy of the treatment on a much larger clinical scale, and merit the construction of a miniaturized portable device.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parameter Determination | Experimental | Device: Transcutaneous current to the vestibular nerveTesting potential effects of GVS on the symptoms of neglect |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All participants must be literate in English
- Right handed
- Have corrected near-visual acuity of 20/40 or better
- Patients must also have a minimum of twelve years education
- These inclusionary criteria are based on the data of both Black, Yu, Martin, and Szalai (90) and our own studies.
Key exclusion criteria (5 listed)
- Homonymous hemianopia
- Presence of a severe field cut extending toward the midline on formal perimetry (however many patients who have field cuts restricted to the periphery will be able to fully perceive our stimulus displays so can be included
- Evidence of aphasia on clinical examination (crossed aphasia)
- A significant history of other neurological or psychiatric illness or drug/alcohol abuse
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 |
|---|---|---|
| Transcutaneous current to the vestibular nerveDelivery of randomly oscillating low level current | Device | Parameter Determination |
Primary outcome
Measures of Hemispatial Neglect
Time frame: 30 days
Improvement of Hemispatial neglect
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 6 Jun 2018.
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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.
William Milberg, PhD principal investigator
VA Medical Center, Jamaica Plain Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous current to the vestibular nerve in people with Hemispatial Neglect and Stroke, run by VA Office of Research and Development 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 6 inclusion and 5 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 6 Jun 2018. 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?
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?
Measures of Hemispatial Neglect (time frame: 30 days). 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 6 Jun 2018.