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: October 1, 2014
Last verified: October 2014

December 28, 2005
October 1, 2014
January 2006
December 2008   (final data collection date for primary outcome measure)
Measures of Hemispatial Neglect [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Improvement of Hemispatial neglect
  • 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
Complete list of historical versions of study NCT00271388 on ClinicalTrials.gov Archive Site
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Vestibular Stimulation to Treat Hemispatial Neglect
Noise Enhanced Galvanic Vestibular Stimulation in Hemispatial Neglect

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.

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.

Interventional
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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Hemispatial Neglect
  • Stroke
Device: Transcutaneous current to the vestibular nerve
Delivery of randomly oscillating low level current
Experimental: Parameter Determination
Testing potential effects of GVS on the symptoms of neglect
Intervention: Device: Transcutaneous current to the vestibular nerve
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
40 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00271388
C3868-R
Not Provided
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: William Milberg, PhD VA Medical Center, Jamaica Plain Campus
Department of Veterans Affairs
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP