Phase I Deep Brain Stimulation (DBS) vs. Best Medical Therapy (BMT) Trial

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00056563
First received: March 18, 2003
Last updated: April 24, 2014
Last verified: April 2014

March 18, 2003
April 24, 2014
April 2002
October 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00056563 on ClinicalTrials.gov Archive Site
The Change of Scores on the UPDRS for Blinded Assessed Motor Function 'Off' Medication and 'on' Stimulation [ Time Frame: at six months ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
Not Provided
 
Phase I Deep Brain Stimulation (DBS) vs. Best Medical Therapy (BMT) Trial
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

The goals of this study are to determine if simultaneous bilateral subthalamic nucleus stimulation or simultaneous bilateral globus pallidus stimulation is more effective in reducing symptoms of Parkinson's disease, and if deep brain stimulation or best medical therapy is more effective in improving Parkinson's disease symptoms

Deep Brain Stimulation (DBS) is a promising therapy for Parkinson's disease (PD). Whether DBS is superior to comprehensive best medical therapy or whether some patients or symptoms respond better to DBS in one area of the brain or the other is currently not known. The goals of this project are to compare the effectiveness of DBS and comprehensive medical therapy as treatments for PD, and to compare bilateral DBS at 2 areas of the brain--the subthalamic nucleus (STN) and the globus pallidus (Gpi)--to determine the most effective brain site for surgical intervention In this prospective, randomized, multi-center trial, 316 patients will be enrolled at 13 centers over four and a half years. Patients will initially be randomized to immediate surgery (DBS) or to 6 months of "best medical therapy." BMT patients will then proceed into the surgical phase of the trial. 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. Patients will be followed for two years post surgery (24-30 months). 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 findings will be critically important in establishing the optimal surgical treatment of the disabling symptoms of PD.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson's Disease
  • 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.
  • 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.
  • Active Comparator: 1
    Deep Brain Stimulation
    Intervention: Device: Bilateral Deep Brain Stimulation
  • Active Comparator: 2
    Best Medical Therapy
    Intervention: Other: best medical therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
255
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
22 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00056563
468 Phase I
Yes
Department of Veterans Affairs
Department of Veterans Affairs
National Institute of Neurological Disorders and Stroke (NINDS)
Study Chair: Kenneth Follett VA Medical Center, Iowa City
Study Chair: Frances M. Weaver, PhD MA BA Edward Hines Jr. VA Hospital
Department of Veterans Affairs
April 2014

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