NCT00271388

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2005

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

2.9 years

First QC Date

December 28, 2005

Last Update Submit

June 4, 2018

Conditions

Hemispatial NeglectStroke

Keywords

Galvanic Vestibular StimulationHemispatial NeglectStroke

Outcome Measures

Primary Outcomes (1)

  • Measures of Hemispatial Neglect

    Improvement of Hemispatial neglect

    30 days

Study Arms (1)

Parameter Determination

EXPERIMENTAL

Testing potential effects of GVS on the symptoms of neglect

Device: Transcutaneous current to the vestibular nerve

Interventions

Transcutaneous current to the vestibular nerveDEVICE

Delivery of randomly oscillating low level current

Parameter Determination

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • They are intended to assure that only patients with sufficiently severe symptoms will be admitted to our study.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Jamaica Plain Campus

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Perceptual DisordersStroke

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • William Milberg, PhD

    VA Medical Center, Jamaica Plain Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2005

First Posted

December 30, 2005

Study Start

January 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

June 6, 2018

Record last verified: 2018-06

Locations

US(1)