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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
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
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on November 25, 2014