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Vestibular Stimulation to Treat Hemispatial Neglect

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00271388
First Posted: December 30, 2005
Last Update Posted: October 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  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
Hemispatial Neglect Stroke Device: Transcutaneous current to the vestibular nerve

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Noise Enhanced Galvanic Vestibular Stimulation in Hemispatial Neglect

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Measures of Hemispatial Neglect [ Time Frame: 30 days ]
    Improvement of Hemispatial neglect


Enrollment: 2
Study Start Date: January 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Parameter Determination
Testing potential effects of GVS on the symptoms of neglect
Device: Transcutaneous current to the vestibular nerve
Delivery of randomly oscillating low level current

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271388


Locations
United States, Massachusetts
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: William Milberg, PhD VA Medical Center, Jamaica Plain Campus
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00271388     History of Changes
Other Study ID Numbers: C3868-R
First Submitted: December 28, 2005
First Posted: December 30, 2005
Last Update Posted: October 3, 2014
Last Verified: October 2014

Keywords provided by VA Office of Research and Development:
Galvanic Vestibular Stimulation
Hemispatial Neglect
Stroke

Additional relevant MeSH terms:
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms