NCT00004670

Brief Summary

OBJECTIVES: I. Evaluate the safety and efficacy of pallidotomy immediately following 3 preoperative assessments vs. delayed pallidotomy following 6 months of standard medical therapy in patients with Parkinson disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 parkinson-disease

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1994

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2000

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2001

First QC Date

February 24, 2000

Last Update Submit

June 23, 2005

Conditions

Parkinson Disease

Keywords

Parkinson diseaseneurologic and psychiatric disordersrare disease

Interventions

pallidotomyPROCEDURE

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Idiopathic Parkinson disease Hoehn and Yahr stage III or worse during "off" periods Responsive to levodopa by history or exam Sub-optimal clinical response to maximal medication Medication optimized for at least 4 weeks prior to entry No atypical or secondary disease, e.g.: * No history of cerebrovascular accident * No cerebellar involvement * No severe brain atrophy on magnetic resonance imaging No Mattis Dementia Rating Scale score less than 116 No dementia meeting Diagnostic and Statistical Manual of Mental Disorders-IV criteria No Hamilton Depression Rating Scale score greater than 10 No Hamilton Anxiety Scale score greater than 14 --Patient Characteristics-- Other: No medical contraindication to surgery, e.g.: * Diabetes * Cardiopulmonary disease

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson DiseaseNeurologic ManifestationsMental DisordersRare Diseases

Interventions

Pallidotomy

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Neurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Mahlon R. DeLong

    Emory University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 24, 2000

First Posted

February 25, 2000

Study Start

October 1, 1994

Last Updated

June 24, 2005

Record last verified: 2001-12