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Phase II Study of Pallidotomy for Parkinson Disease

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ClinicalTrials.gov Identifier: NCT00004670
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Emory University
Information provided by:
Office of Rare Diseases (ORD)

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Procedure: pallidotomy Phase 2

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 Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : October 1994

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U.S. FDA Resources





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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004670


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

ClinicalTrials.gov Identifier: NCT00004670     History of Changes
Other Study ID Numbers: 199/12083
EUSM-018
EUSM-409-92
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2001

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