VA Cooperative Studies Program (CSP)

Investigator Access
CSP #468

What's Available

Check with study contact or publications for information on a public dataset, data archive, data enclave, or website where data might be available.

Available Documentation 

Dates Data are Available 

Access Criteria

Study Characteristics
CSP #468

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 that met the inclusion and exclusion criteria

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 

• Arm 1 - Bilateral DBS surgery of the STN
• Arm 2 - Bilateral DBS surgery of the GPi

Time Period 

April 2002 - April 2009

Setting 

National 

N 

Phase I: 255 participants 
Phase II: 299 participants

Response Rate

Unconfirmed

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

Unconfirmed

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 Sources

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

Investigators

• Co-Investigator: Kenneth Follett, MD, PhD, F.A.C.S.
• Co-Investigator: Fran Weaver, PhD
• Co-Investigator: Matthew Stern, MD

Contact 

Study Contact: Tammy Barnett; 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)
• Dimensions for VA summary (Requires an account to access outside the VA network. Dimensions for VA is a database that connects publications, grants, patents, clinical trials, and policy documents)
• CSP #468-F: Follow Up Study for Treatment of Parkinson’s Disease with Deep Brain Stimulation (below)

Investigator Access
CSP #468-F

What's Available

Check with study contact or publications for information on a public dataset, data archive, data enclave, or website where data might be available.

Available Documentation 

Dates Data are Available 

Access Criteria

Data can be shared based on VA Approved Data Use Agreement (DUA). Investigators associated with VA or non-VA nonprofit, academic, or research institutions may submit a Research Resource Request form to Tammy.Barnett@va.gov.

Investigators may be asked to provide further documentation such as a study proposal. All requests are reviewed for scientific and ethical merit. Access is contingent upon approval by the requestor’s Institutional Review Board (IRB) and, if applicable, a VA Research and Development (R&D) Committee. To gain access, requestors must sign a VA data use agreement. Requestors must be fully compliant with VA data security, privacy, and human subjects requirements.

Study Characteristics
CSP #468-F

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 

Time Period 

June 2010 - April 2015 

Setting

National

N 

156 participants (86 targeting GPi, 70 targeting STN)

Response Rate

61.18% of main CSP #468 participants

Recruitment Method

Participants from CSP #468 were invited to participate

Compensation

Unconfirmed

Data Collected

Primary outcome

Off-medication/on-stimulation motor function measured as a change score of UPDRS Part III from baseline to 9 years 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 Methods

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

Funding Sources

VA Office of Research and Development (ORD)
National Institute of Neurological Disorders and Strokes (NINDS)

Investigators

• Co-Investigator: William Marks, Jr., MD
• Co-Investigator: Fran Weaver, PhD
• Co-Investigator: Kenneth Follett, MD, PhD, F.A.C.S.
• Co-Investigator: Matthew Stern, MD

Contact 

Study Contact: Tammy Barnett; Tammy.Barnett@va.gov

Selected Publications 

Unconfirmed

More Information 

• Study ClinicalTrials.gov site
• ClinicalTrials.gov Identifier: NCT01022073
• Dimensions for VA summary (Requires an account to access outside the VA network. Dimensions for VA is a database that connects publications, grants, patents, clinical trials, and policy documents)