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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Deep Brain Stimulation |
|
| 2 | Active Comparator | Best Medical Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral Deep Brain Stimulation | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Difference of Time Spent in the 'on' State Without Troublesome Dyskinesia Based on Patient Motor Diaries as Compared to the Baseline. | at six months |
| Measure | Description | Time Frame |
|---|---|---|
| The Change of Scores on the UPDRS for Blinded Assessed Motor Function 'Off' Medication and 'on' Stimulation | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Follett | VA Medical Center, Iowa City | Study Chair |
| Frances M. Weaver, PhD MA BA | Edward Hines Jr. VA Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at Los Angeles | Los Angeles | California | 90095 | United States | ||
| VA Medical Center, San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16216957 | Result | Follett K, Weaver F, Stern M, Marks W, Hogarth P, Holloway K, Bronstein J, Duda J, Horn S, Lai E, Samii A. Multisite randomized trial of deep brain stimulation. Arch Neurol. 2005 Oct;62(10):1643-4; author reply 1644-5. doi: 10.1001/archneur.62.10.1643-b. No abstract available. | |
| 16381181 | Result | Weaver F, Follett K, Hur K, Ippolito D, Stern M. Deep brain stimulation in Parkinson disease: a metaanalysis of patient outcomes. J Neurosurg. 2005 Dec;103(6):956-67. doi: 10.3171/jns.2005.103.6.0956. |
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An additional 23 patients were screened after signing the informed consent form but not randomized. 11 of them weren't willing to participate in the follow-up visits after intervention, 7 of them had neuropsychological dysfunction, 2 of them were not responsive to levodopa, and 3 had medical contraindication to surgery and/or DBS stimulation.
Patient recruitment begun in May 2002 and the discontinuation of randomization to the BMT arm was approved in August 2005 and participating sites received their IRB approval of this change through October 2005. A total of 255 patients were randomized to either BMT or DBS from 7 VA medical centers and 6 affiliated university sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1: Bilateral Deep Brain Stimulation | Bilateral Deep Brain Stimulation 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. |
| FG001 | 2: Best Medical Therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| best medical therapy | Other | 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. |
|
| at six months |
| San Francisco |
| California |
| 94121 |
| United States |
| University of California at San Francisco | San Francisco | California | 94143 | United States |
| VA Greater Los Angeles Healthcare System, West LA | West Los Angeles | California | 90073 | United States |
| VA Medical Center, Iowa City | Iowa City | Iowa | 52246-2208 | United States |
| VA Medical Center, Portland | Portland | Oregon | 97201 | United States |
| Oregon Health Sciences University | Portland | Oregon | 97239 | United States |
| VA Medical Center, Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Michael E. DeBakey VA Medical Center (152) | Houston | Texas | 77030 | United States |
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
| Medical College of Virginia | Richmond | Virginia | 23298 | United States |
| VA Puget Sound Health Care System, Seattle | Seattle | Washington | 98108 | United States |
| 17052655 | Result | Weaver FM, Stern MB, Follett K. Deep-brain stimulation in Parkinson's disease. Lancet Neurol. 2006 Nov;5(11):900-1. doi: 10.1016/S1474-4422(06)70586-5. No abstract available. |
| 19126811 | Result | 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 Jan 7;301(1):63-73. doi: 10.1001/jama.2008.929. |
| 19454631 | Result | Genever RW. Deep brain stimulation for patients with advanced Parkinson disease. JAMA. 2009 May 20;301(19):1985; author reply 1985-6. doi: 10.1001/jama.2009.647. No abstract available. |
| 20519680 | Result | 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. doi: 10.1056/NEJMoa0907083. |
| 20830819 | Result | Hou B, Jiang T, Liu R. Deep-brain stimulation for Parkinson's disease. N Engl J Med. 2010 Sep 2;363(10):987-8; author reply 988. doi: 10.1056/NEJMc1007650. No abstract available. |
| 20937936 | Result | Bronstein JM, Tagliati M, Alterman RL, Lozano AM, Volkmann J, Stefani A, Horak FB, Okun MS, Foote KD, Krack P, Pahwa R, Henderson JM, Hariz MI, Bakay RA, Rezai A, Marks WJ Jr, Moro E, Vitek JL, Weaver FM, Gross RE, DeLong MR. Deep brain stimulation for Parkinson disease: an expert consensus and review of key issues. Arch Neurol. 2011 Feb;68(2):165. doi: 10.1001/archneurol.2010.260. Epub 2010 Oct 11. |
| 41626017 | Derived | Ostrem JL, Luo P, Weaver FM, Follett K, Rothlind J, Galifianakis NB, Lai EC, Bronstein J, Duda J, Holloway K, Sarwar A, Brodsky M, Chung K, Spindler M, Reda D, Snodgrass A, Moy C, Huang G, Wei Y, Marks WJ Jr; CSP 468F Study Group. 10-year clinical outcomes of subthalamic nucleus versus pallidal deep brain stimulation for Parkinson's disease: VA/NINDS CSP #468F. Front Neurol. 2026 Jan 16;16:1728999. doi: 10.3389/fneur.2025.1728999. eCollection 2025. |
| 25185211 | Derived | 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. doi: 10.1136/jnnp-2014-308119. Epub 2014 Sep 2. |
| 23667214 | Derived | 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. doi: 10.1136/jnnp-2012-304396. Epub 2013 May 10. |
Best Medical Therapy best medical therapy : Participants will initially be randomized to DBS or to 6 months of |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1: Bilateral Deep Brain Stimulation | Bilateral Deep Brain Stimulation 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. |
| BG001 | 2: Best Medical Therapy | Best Medical Therapy 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Difference of Time Spent in the 'on' State Without Troublesome Dyskinesia Based on Patient Motor Diaries as Compared to the Baseline. | Posted | Mean | 95% Confidence Interval | Hours per day | at six months |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | The Change of Scores on the UPDRS for Blinded Assessed Motor Function 'Off' Medication and 'on' Stimulation | 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. | Posted | Mean | 95% Confidence Interval | units | at six months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1: Bilateral Deep Brain Stimulation | Bilateral Deep Brain Stimulation 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. | 49 | 121 | 116 | 121 | ||
| EG001 | 2: Best Medical Therapy | Best Medical Therapy 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. | 15 | 134 | 97 | 134 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical Site Infection | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Confusional State | Psychiatric disorders | Non-systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Non-systematic Assessment |
| ||
| Dyskinesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Mental status changes | Psychiatric disorders | Non-systematic Assessment |
| ||
| Procedural complications | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Adverse drug reaction | General disorders | Non-systematic Assessment |
| ||
| Angina Unstable | Cardiac disorders | Non-systematic Assessment |
| ||
| Angioplasty, Bone Graft, transurethral prostatectomy | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
| ||
| Arthritis infective | Infections and infestations | Non-systematic Assessment |
| ||
| Benign prostatic hyperplasia | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Chronic Obstructive Pulmonary disease, Pleuritic Pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Deep Vein Thrombosis, Orthostatic hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hallucination | Psychiatric disorders | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Coronary Artery Insufficiency | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiac Failure Congestive | Cardiac disorders | Non-systematic Assessment |
| ||
| Coronary artery disease | Cardiac disorders | Non-systematic Assessment |
| ||
| Coronary artery occlusion | Cardiac disorders | Non-systematic Assessment |
| ||
| Gastrooesopageal Reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Inguinal hernia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Lethargy | General disorders | Non-systematic Assessment |
| ||
| Mechanical complication of implant | General disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Drug Hypersensitivity | Immune system disorders | Non-systematic Assessment |
| ||
| Urinary Tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Complication of device removal | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Device migration | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Medical Device complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Medical device discomfort | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Subdural haematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Wound dehiscence | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Glioma, Lung Neoplasm malignant, Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Nervous system disorders | Nervous system disorders | Non-systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Sexual Dysfunction | Psychiatric disorders | Non-systematic Assessment |
| ||
| Activities of daily living impaired | Social circumstances | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Motor Dysfunction | Nervous system disorders | Non-systematic Assessment |
| ||
| Dyskinesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Tremor | Nervous system disorders | Non-systematic Assessment |
| ||
| Gait disturbance | Nervous system disorders | Non-systematic Assessment |
| ||
| Bradykinesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Balance disorder | Nervous system disorders | Non-systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Muscle rigidity | Nervous system disorders | Non-systematic Assessment |
| ||
| Speech disorder | Nervous system disorders | Non-systematic Assessment |
| ||
| Orthostatic hypotension | Vascular disorders | Non-systematic Assessment |
| ||
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Confusional state | Psychiatric disorders | Non-systematic Assessment |
| ||
| Dystonia | Nervous system disorders | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Pain | General disorders | Non-systematic Assessment |
| ||
| Freezing phenomenon | Nervous system disorders | Non-systematic Assessment |
| ||
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Akinesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Incision site pain | General disorders | Non-systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Procedural pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Drooling | Nervous system disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Implant site infection | Infections and infestations | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
A limitation of this study is that the STN and GPi cases are pooled into a single DBS group. When the study was planned, it was thought that differences between STN and GPi at six months would be small, which was tested during the study analysis.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frances M. Weaver, Ph.D, Study Investigator | Center for Management of Complex Chronic Care | (708) 202-2414 | Frances.Weaver@va.gov |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D014202 | Tremor |
| D020820 | Dyskinesias |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
|
| Male |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|