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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00271388 |
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 |
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Stroke Hemispatial Neglect |
Device: Transcutaneous current to the vestibular nerve |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Single Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Noise Enhanced Galvanic Vestibular Stimulation in Hemispatial Neglect |
Estimated Enrollment: | 27 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2008 |
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.
Ages Eligible for Study: | 40 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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.
Contact: William Milberg, Ph.D. | 617-232-9500 ext 2946 | wpm@bu.edu |
United States, Massachusetts | |
VA Boston Healthcare System | |
Boston, Massachusetts, United States, 02459 |
Principal Investigator: | William Milberg, Ph.D. | VA Boston Healthcare System |
Study ID Numbers: | C3868R |
Study First Received: | December 28, 2005 |
Last Updated: | December 28, 2005 |
ClinicalTrials.gov Identifier: | NCT00271388 |
Health Authority: | United States: Federal Government |
Stroke Hemispatial Neglect Galvanic Vestibular Stimulation |
Signs and Symptoms Cerebral Infarction Stroke Vascular Diseases Neurologic Manifestations |
Central Nervous System Diseases Brain Diseases Neurobehavioral Manifestations Cerebrovascular Disorders Perceptual Disorders |
Nervous System Diseases Cardiovascular Diseases |