Vestibular Stimulation to Treat Hemispatial Neglect

Stroke Clinical Trial

Official title:

Noise Enhanced Galvanic Vestibular Stimulation in Hemispatial Neglect

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00271388
• Other study ID #: C3868-R
• Status: Completed
• Phase: N/A
• Start date: January 2006
• Est. completion date: December 2008

Study information

• Verified date: June 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemispatial Neglect
• Perceptual Disorders
• Stroke

Intervention

Device:
• Transcutaneous current to the vestibular nerve
Delivery of randomly oscillating low level current

Locations

Country	Name	City	State
United States	VA Medical Center, Jamaica Plain Campus	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measures of Hemispatial Neglect	Improvement of Hemispatial neglect	30 days