Phase II Study of Pallidotomy for Parkinson Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

February 24, 2000

Last Updated Date

June 23, 2005

Start Date ^ICMJE

October 1994

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004670 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Phase II Study of Pallidotomy for Parkinson Disease

Official Title ^ICMJE

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.

Detailed Description

PROTOCOL OUTLINE: This is a randomized study. One group of patients undergoes the surgical procedure pallidotomy, a precise lesioning of brain cells in the globus pallidus.

The other group receives standard medical care for 6 months followed by a pallidotomy.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized

Condition ^ICMJE

Parkinson Disease

Intervention ^ICMJE

Procedure: pallidotomy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004670

Responsible Party

Study ID Numbers ^ICMJE

199/12083, EUSM-018, EUSM-409-92

Study Sponsor ^ICMJE

National Center for Research Resources (NCRR)

Collaborators ^ICMJE

Emory University

Investigators ^ICMJE

Study Chair:

Mahlon R. DeLong

Emory University

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

December 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP