Phase II Study of Pallidotomy for Parkinson Disease

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.

Completed

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Disease Attributes Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Signs and Symptoms Synucleinopathies

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pallidotomy

Procedure

Sponsors and collaborators

Lead sponsor

National Center for Research Resources (NCRR)

Nih

Collaborators

Emory University

Registry information

Important dates

Study start: 1994
First posted: Feb 25, 2000
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed