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Vestibular Stimulation to Treat Hemispatial Neglect

Primary Purpose

Hemispatial Neglect, Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous current to the vestibular nerve
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Hemispatial Neglect focused on measuring Galvanic Vestibular Stimulation, Hemispatial Neglect, Stroke

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Medical Center, Jamaica Plain Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Parameter Determination

Arm Description

Testing potential effects of GVS on the symptoms of neglect

Outcomes

Primary Outcome Measures

Measures of Hemispatial Neglect
Improvement of Hemispatial neglect

Secondary Outcome Measures

Full Information

First Posted
December 28, 2005
Last Updated
June 4, 2018
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00271388
Brief Title
Vestibular Stimulation to Treat Hemispatial Neglect
Official Title
Noise Enhanced Galvanic Vestibular Stimulation in Hemispatial Neglect
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemispatial Neglect, Stroke
Keywords
Galvanic Vestibular Stimulation, Hemispatial Neglect, Stroke

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parameter Determination
Arm Type
Experimental
Arm Description
Testing potential effects of GVS on the symptoms of neglect
Intervention Type
Device
Intervention Name(s)
Transcutaneous current to the vestibular nerve
Intervention Description
Delivery of randomly oscillating low level current
Primary Outcome Measure Information:
Title
Measures of Hemispatial Neglect
Description
Improvement of Hemispatial neglect
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Milberg, PhD
Organizational Affiliation
VA Medical Center, Jamaica Plain Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Jamaica Plain Campus
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States

12. IPD Sharing Statement

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Vestibular Stimulation to Treat Hemispatial Neglect

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