Vestibular Stimulation to Treat Hemispatial Neglect

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00271388
First received: December 28, 2005
Last updated: September 27, 2013
Last verified: September 2013
  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 Blind (Subject)
Primary Purpose: Treatment
Official Title: Noise Enhanced Galvanic Vestibular Stimulation in Hemispatial Neglect

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Measures of Hemispatial Neglect [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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

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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00271388     History of Changes
Other Study ID Numbers: C3868-R
Study First Received: December 28, 2005
Last Updated: September 27, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on September 18, 2014