CSP #468 (Main study) & CSP #468-F (Follow-up study) - VA Cooperative Studies Program (CSP)
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VA Cooperative Studies Program (CSP)

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CSP #468 (Main study) & CSP #468-F (Follow-up study)

Main Study:
CSP #468: A Comparison of Best Medical Therapy and Deep Brain Stimulation of Subthalamic Nucleus and Globus Pallidus for the Treatment of Parkinson’s Disease

Follow-up study:   
CSP #468-F: Follow Up Study for Treatment of Parkinson’s Disease with Deep Brain Stimulation
  

Data Sharing Statement
CSP #468: A Comparison of Best Medical Therapy and Deep Brain Stimulation of Subthalamic Nucleus and Globus Pallidus for the Treatment of Parkinson’s Disease

What's available

Pending

Available Documentation 

Pending

Dates Data are Available 

Pending

Access Criteria

Pending

Study Characteristics
CSP #468: A Comparison of Best Medical Therapy and Deep Brain Stimulation of Subthalamic Nucleus and Globus Pallidus for the Treatment of Parkinson’s Disease

Objectives

Phase I: To compare the effectiveness of deep brain stimulation (DBS) and comprehensive medical therapy as treatments for Parkinson’s disease (PD) 
Phase II: 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

Era of Service

All

Population

Male and female patients with idiopathic PD who were at least 21 years of age and received care at VA medical centers

Study Design 

Prospective, randomized, controlled, blinded clinical trial

Intervention 

Phase I

  • Arm 1 - Bilateral DBS surgery of the STN or GPi
  • Arm 2 - Best medical therapy actively managed by movement disorder neurologists 
Phase II
  • Arm 1 - Bilateral DBS surgery of the STN
  • Arm 2 - Bilateral DBS surgery of the GPi

Time Period 

April 2002 - April 2009

Setting 

National 

Phase I: 255
Phase II: 299

Response Rate

N/A

Recruitment Method

Patients from 7 VA medical centers were recruited by provider referrals to study neurologists and patient self-referral. Site coordinators assessed patient eligibility and obtained informed consent and baseline assessments.

Compensation

Pending

Data Collected

Primary outcomes

  • Time spent in the “on” state (good motor control with unimpeded motor function) without troubling dyskinesia, using motor diaries
  • Motor function assessed by the 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 

Secondary outcomes

  • Mentation, behavior, and mood (UPDRS I)
  • Activities of daily living (UPDRS II, Schwab & England scale)
  • Motor function while not taking medication (UPDRS III)
  • Complications of therapy (UPDRS IV)
  • Neurocognitive functioning (e.g., dementia, processing speed, working memory, language, learning, executive functioning)
  • Timed walking test
  • PD severity (Hoehn & Yahr Score)
  • Health-related quality of life (PDQ-39)
  • Postural and gait control (timed “stand-walk-sit” test)
  • Adverse events

Other assessments

  • Demographics & clinical characteristics 

Data Collection Methods

  • In-person clinical evaluations
  • Self-reported structured questionnaires
  • Case report forms completed through an electronic data capture system

Funding Source

  • VA Cooperative Studies Program (CSP)
  • National Institute of Neurological Disorders and Stroke
  • Medtronic, Inc.

Contact 

Tammy.Barnett@va.gov

Selected Publications 

Weaver FM, Follett K, Stern M, Hur K, Harris C, Marks WJ Jr, Rothlind J, Sagher O, Reda D, Moy CS, Pahwa R, Burchiel K, Hogarth P, Lai EC, Duda JE, Holloway K, Samii A, Horn S, Bronstein J, Stoner G, Heemskerk J, Huang GD; CSP 468 Study Group. Bilateral deep brain stimulation vs best medical therapy for patients with advanced Parkinson disease: a randomized controlled trial. JAMA 2009;301:63–73.

Follett KA, Weaver FM, Stern M, Hur K, Harris CL, Luo P, Marks WJ Jr, Rothlind J, Sagher O, Moy C, Pahwa R, Burchiel K, Hogarth P, Lai EC, Duda JE, Holloway K, Samii A, Horn S, Bronstein JM, Stoner G, Starr PA, Simpson R, Baltuch G, De Salles A, Huang GD, Reda DJ; CSP 468 Study Group. Pallidal versus subthalamic deep-brain stimulation for Parkinson's disease. N Engl J Med. 2010 Jun 3;362(22):2077-91.

Weintraub D, Duda JE, Carlson K, Luo P, Sagher O, Stern M, Follett KA, Reda D, Weaver FM; CSP 468 Study Group. Suicide ideation and behaviours after STN and GPi DBS surgery for Parkinson's disease: results from a randomised, controlled trial. J Neurol Neurosurg Psychiatry. 2013 Oct;84(10):1113-8. Epub 2013 May 10.

Rothlind JC, York MK, Carlson K, Luo P, Marks WJ Jr, Weaver FM, Stern M, Follett K, Reda D; CSP-468 Study Group. Neuropsychological changes following deep brain stimulation surgery for Parkinson's disease: comparisons of treatment at pallidal and subthalamic targets versus best medical therapy. J Neurol Neurosurg Psychiatry. 2015 Jun;86(6):622-9.

More Information 

ClinicalTrials.gov Sites: Phase I and Phase II
ClinicalTrials.gov Identifiers: NCT00056563 (Phase I) and NCT01076452 (Phase II)
CSP #468-F: Follow Up Study for Treatment of Parkinson’s Disease with Deep Brain Stimulation (below)



  

Data Sharing Statement
CSP #468-F: Follow Up Study for Treatment of Parkinson’s Disease with Deep Brain Stimulation

What's available

Pending

Available Documentation 

Pending

Dates Data are Available 

Pending

Access Criteria

Pending

Study Characteristics
CSP #468-F: Follow Up Study for Treatment of Parkinson’s Disease with Deep Brain Stimulation

Objectives

  • To determine whether motor benefits of deep brain stimulation (DBS) persist beyond two years of follow-up in patients with Parkinson’s Disease (PD)
  • To determine whether target of stimulation—the globus pallidus (GPi) vs. subthalamic nucleus (STN)—affects durability of long-term motor improvement
  • To define impact of DBS on long-term function and quality of life in patients with Parkinson’s disease
  • To identify clinical features that predict favorable or unfavorable long-term outcome
  • To describe long-term performance of DBS devices, including device durability, device explanation rate, neurostimulator replacement frequency, and changes in stimulation parameters to achieve optimum symptom control

Era of Service

All

Population

Male and female patients with PD enrolled in CSP #468 and received deep brain stimulation (DBS) devices that were still working and in place

Study Design 

Prospective cohort study

Time Period 

June 2010 - April 2015 

Setting

National

156 participants (86 targeting GPi, 70 targeting STN)

Response Rate

61.18% of CSP #468 participants

Recruitment Method

Participants from CSP #468 were invited to participate

Compensation

Pending

Data Collected

Primary outcomes

  • Time spent in the “on” state (good motor control with unimpeded motor function) without troubling dyskinesia, using motor diaries
  • Motor function assessed by the 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 

Secondary outcomes

  • Mentation, behavior, and mood (UPDRS I)
  • Activities of daily living (UPDRS II, Schwab & England scale)
  • Complications of therapy (UPDRS IV)
  • Timed walking test
  • PD severity (Hoehn & Yahr Score)
  • Health-related quality of life (PDQ-39)
  • Postural and gait control (timed “stand-walk-sit” test)
  • Neurocognitive functioning (e.g., dementia, working memory, verbal fluency)
  • Depression (Beck Depression Inventory)
  • Medication dose and device replacement frequency
  • "On", "off", "on with dyskinesias", or asleep assessed by motor fluctuation diary
  • Total daily levodopa equivalent medication requirements

Other assessments

  • Demographics & baseline measures of study outcomes 

Data Collection Method

  • In-person clinical evaluations
  • Structured phone interviews 
  • Case report forms completed through an electronic data capture system

Funding Source

  • VA Cooperative Studies Program (CSP)
  • National Institute of Neurological Disorders and Strokes

Contact 

Tammy.Barnett@va.gov

Selected Publications 

Pending

More Information 

Study ClinicalTrials.gov site
ClinicalTrials.gov Identifier: NCT01022073