Phase I Deep Brain Stimulation (DBS) vs. Best Medical Therapy (BMT) Trial
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ClinicalTrials.gov Identifier: NCT00056563 |
Recruitment Status :
Completed
First Posted : March 19, 2003
Results First Posted : July 30, 2013
Last Update Posted : May 9, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson's Disease | Device: Bilateral Deep Brain Stimulation Other: best medical therapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 255 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | CSP #468 Phase I - A Comparison of Best Medical Therapy and Deep Brain Stimulation of Subthalamic Nucleus and Globus Pallidus for the Treatment of Parkinson's Disease |
Study Start Date : | April 2002 |
Actual Primary Completion Date : | October 2008 |
Actual Study Completion Date : | October 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Deep Brain Stimulation
|
Device: Bilateral Deep Brain Stimulation
The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial. |
Active Comparator: 2
Best Medical Therapy
|
Other: best medical therapy
Participants will initially be randomized to DBS or to 6 months of "best medical therapy." BMT participants will then proceed into the surgical phase of the trial. Effective 08/05/05, randomization to the BMT arm has been discontinued since the study has sufficient information to compare the outcomes of DBS and BMT patients at 6 months. |
- The Difference of Time Spent in the 'on' State Without Troublesome Dyskinesia Based on Patient Motor Diaries as Compared to the Baseline. [ Time Frame: at six months ]
- The Change of Scores on the UPDRS for Blinded Assessed Motor Function 'Off' Medication and 'on' Stimulation [ Time Frame: at six months ]Unified Parkinson's Disease Rating Scale (UPDRS Part III) measured while the patient is off medications and on stimulation at follow-up visits post surgery. UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. A summary score ranging from 0 to 108 is generated by adding the 14 specific motor function responses. The motor function (UPDRS part III) assessments are done by turning on the stimulation with and without taking PD medications (on/off) at each in-person visit. The higher score indicates that the condition is worse.

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Ages Eligible for Study: | 22 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- idiopathic Parkinson's disease,
- Hoehn and Yahr stage 2 or worse "off" medications,
- L-dopa responsive but with persistent disabling symptoms (i.e., refractory to "best medical treatment" with motor fluctuations, dyskinesias),
- on stable medical therapy for at least one month prior to enrollment,
- age > 21,
- available and willing to be followed-up according to study protocol, and
- no intracranial abnormalities that would contraindicate surgery (based on pre-operative magnetic resonance imaging of the brain).
Exclusion Criteria:
- "Parkinson's plus" syndromes,
- medical contraindications to surgery or stimulation,
- active alcohol or drug abuse,
- score on minimental status exam 24 or lower, or other neuropsychological dysfunction (e.g., dementia) that would contraindicate surgery,
- concurrent participation in another research protocol.

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): NCT00056563
United States, California | |
University of California at Los Angeles | |
Los Angeles, California, United States, 90095 | |
VA Medical Center, San Francisco | |
San Francisco, California, United States, 94121 | |
University of California at San Francisco | |
San Francisco, California, United States, 94143 | |
VA Greater Los Angeles Healthcare System, West LA | |
West Los Angeles, California, United States, 90073 | |
United States, Iowa | |
VA Medical Center, Iowa City | |
Iowa City, Iowa, United States, 52246-2208 | |
United States, Oregon | |
VA Medical Center, Portland | |
Portland, Oregon, United States, 97201 | |
Oregon Health Sciences University | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
VA Medical Center, Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
Pennsylvania Hospital | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 | |
Michael E. DeBakey VA Medical Center (152) | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Hunter Holmes McGuire VA Medical Center | |
Richmond, Virginia, United States, 23249 | |
Medical College of Virginia | |
Richmond, Virginia, United States, 23298 | |
United States, Washington | |
VA Puget Sound Health Care System, Seattle | |
Seattle, Washington, United States, 98108 |
Study Chair: | Kenneth Follett | VA Medical Center, Iowa City | |
Study Chair: | Frances M. Weaver, PhD MA BA | Edward Hines Jr. VA Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | US Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00056563 |
Obsolete Identifiers: | NCT00101556 |
Other Study ID Numbers: |
468 Phase I |
First Posted: | March 19, 2003 Key Record Dates |
Results First Posted: | July 30, 2013 |
Last Update Posted: | May 9, 2014 |
Last Verified: | April 2014 |
Parkinson's disease levo-dopa tremor |
dyskinesia subthalamic nucleus globus pallidus |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |