Vestibular Stimulation to Treat Hemispatial Neglect

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00271388
First received: December 28, 2005
Last updated: February 3, 2009
Last verified: January 2006
  Purpose

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.


Condition Intervention
Stroke
Hemispatial Neglect
Device: Transcutaneous current to the vestibular nerve

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Noise Enhanced Galvanic Vestibular Stimulation in Hemispatial Neglect

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Line bisection: Line bisection requires the participant to indicate the midpoint of a horizontal line by dividing it into two equal sections. Neglect patients typically place their mark to the right of center (86), with longer lines producing larg
  • Star Cancellation: Cancellation requires the subject to scan through a printed sheet containing a set of various symbols and place a mark through one specific subset. Relative to line bisection, this task places a much greater emphasis on the proc
  • Straight-ahead pointing: This test provides a more specific measure of their perception of body midline, and any associated egocentric bias. It requires the participant to indicate the precise point at which a small, slow moving stimulus crosses s
  • Visual Search: While these standard clinical tests described above are sensitive to the overall severity of neglect, they provide little quantitative data on the dynamic aspects of attentional distribution. To address this, patients will perform a
  • In the present study, patients will search for an inverted T surrounded by distractors that appear as Ts of different orientations (upright, 900 or 2700). This kind of 'conjunction' search has been shown to place high demands on attention and therefor
  • Based on our previous experience, we anticipate that the bisection, cancellation and pointing tasks will each take around 5 minutes to complete, with the visual search task taking around 10 minutes

Estimated Enrollment: 27
Study Start Date: January 2006
Study Completion Date: December 2008
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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All participants must be literate in English, right handed, and 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. Exclusionary criteria include: (i) homonymous hemianopia, (ii) 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, (iii) evidence of aphasia on clinical examination (crossed aphasia), and (iv) a significant history of other neurological or psychiatric illness or drug/alcohol abuse.

Exclusion Criteria:

Exclusionary criteria include: (i) homonymous hemianopia, (ii) 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, (iii) evidence of aphasia on clinical examination (crossed aphasia), and (iv) a significant history of other neurological or psychiatric illness or drug/alcohol abuse.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271388

Locations
United States, Massachusetts
VA Boston Healthcare System
Boston, Massachusetts, United States, 02459
Sponsors and Collaborators
Investigators
Principal Investigator: William Milberg, Ph.D. VA Boston Healthcare System
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00271388     History of Changes
Other Study ID Numbers: C3868R
Study First Received: December 28, 2005
Last Updated: February 3, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Stroke
Hemispatial Neglect
Galvanic Vestibular Stimulation

Additional relevant MeSH terms:
Stroke
Perceptual Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013