Vestibular Stimulation to Treat Hemispatial Neglect | NCT00271388

Studies
Vestibular Stimulation to Treat Hemispatial Neglect

NCT00271388

Sponsor

VA Office of Research and Development

Status

Completed

Last Update Posted

Jun 6, 2018Actual

Enrollment

2Actual

Phase

Not Applicable

Conditions

Hemispatial Neglect
Stroke

Interventions

Transcutaneous current to the vestibular nerve

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Dec 28, 2005

First Submission Date that Met QC Criteria

Dec 28, 2005

First Posted Date

Dec 30, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2018

Last Update Posted Date

Jun 6, 2018Actual

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parameter Determination	Experimental	Testing potential effects of GVS on the symptoms of neglect	Device: Transcutaneous current to the vestibular nerve

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcutaneous current to the vestibular nerve	Device	Delivery of randomly oscillating low level current	Parameter Determination

Measure	Description	Time Frame
Measures of Hemispatial Neglect	Improvement of Hemispatial neglect	30 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William Milberg, PhD	VA Medical Center, Jamaica Plain Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Medical Center, Jamaica Plain Campus		Boston	Massachusetts	02130	United States

Condition Browse Module

MeSH Terms

ID	Term
D010468	Perceptual Disorders
D020521	Stroke

Ancestor Terms

ID	Term
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided