Vestibular Stimulation to Treat Hemispatial Neglect

Not Applicable

Completed

• Conditions: Hemispatial Neglect; Stroke
• Interventions: Device: Transcutaneous current to the vestibular nerve

• Registration Number: NCT00271388
• Lead Sponsor: VA Office of Research and Development

Brief 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.

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.

Study Timeline

• Study First Submitted: 2005-12-28
• Study First Submitted QC: 2005-12-28
• Study First Posted: 2005-12-30
• Study Start: 2006-01
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-04
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Parameter Determination	Transcutaneous current to the vestibular nerve	Testing potential effects of GVS on the symptoms of neglect

Primary Outcome Measures

Name	Time	Method
Measures of Hemispatial Neglect	30 days	Improvement of Hemispatial neglect

Trial Locations

Locations (1)

VA Medical Center, Jamaica Plain Campus; 🇺🇸 Boston, Massachusetts, United States