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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00271388
Other study ID # C3868-R
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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