Vestibular Stimulation to Treat Hemispatial Neglect

NCT ID: NCT00271388

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2008-12-31

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.

Conditions

Hemispatial Neglect; Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: SINGLE

Study Groups

Parameter Determination

Testing potential effects of GVS on the symptoms of neglect

Group Type: EXPERIMENTAL

Transcutaneous current to the vestibular nerve

Intervention Type: DEVICE

Delivery of randomly oscillating low level current

Interventions

Transcutaneous current to the vestibular nerve

Delivery of randomly oscillating low level current

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Milberg, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center, Jamaica Plain Campus

Locations

VA Medical Center, Jamaica Plain Campus

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

C3868-R

Identifier Type: -

Identifier Source: org_study_id