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

February 24, 2000
June 23, 2005
October 1994
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Complete list of historical versions of study NCT00004670 on ClinicalTrials.gov Archive Site
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Phase II Study of Pallidotomy for Parkinson Disease
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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.

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.

Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
Parkinson Disease
Procedure: pallidotomy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004670
199/12083, EUSM-018, EUSM-409-92
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National Center for Research Resources (NCRR)
Emory University
Study Chair: Mahlon R. DeLong Emory University
Office of Rare Diseases (ORD)
December 2001

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