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Phase II Study of Pallidotomy for Parkinson Disease

This study has been completed.
Sponsor:
Collaborator:
Emory University
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004670
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001
History of Changes
  Purpose

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.


Condition Intervention Phase
Parkinson Disease
 Procedure: pallidotomy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 60
Study Start Date: October 1994
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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004670

Sponsors and Collaborators
National Center for Research Resources (NCRR)
Emory University
Investigators
Study Chair: Mahlon R. DeLong Emory University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004670     History of Changes
Other Study ID Numbers: 199/12083, EUSM-018, EUSM-409-92
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
Parkinson disease
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 19, 2013