Phase II Study of Pallidotomy for Parkinson Disease

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

pallidotomy

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, neurologic and psychiatric disorders, rare disease

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004670

First Posted

February 24, 2000

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

Emory University

1. Study Identification

Unique Protocol Identification Number

NCT00004670

Brief Title

Phase II Study of Pallidotomy for Parkinson Disease

Study Type

Interventional

2. Study Status

Record Verification Date

December 2001

Overall Recruitment Status

Completed

Study Start Date

October 1994 (undefined)

Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

Emory University

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

Parkinson disease, neurologic and psychiatric disorders, rare disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

pallidotomy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mahlon R. DeLong

Organizational Affiliation

Emory University

Official's Role

Study Chair

Parkinson Disease

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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