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| ID | Type | Description | Link |
|---|---|---|---|
| VA-NINDS-01 | Other Identifier | NIH-NINDS |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| Medtronic | INDUSTRY |
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The goal of the second phase of the study is to determine if simultaneous bilateral subthalamic nucleus stimulation or simultaneous bilateral globus pallidus stimulation is more effective in reducing symptoms of Parkinson's Disease.
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 (Phase I) 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 (Phase II) 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 arm patients will then be randomized to proceed into the DBS surgical phase of the trial. The DBS site (STN pr 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 months for DBS only patients and 30 months for BMT-DBS patients) Effective 8/5/05 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 |
|---|---|---|---|
| STN | Active Comparator | Participants were randomized to receive deep brain stimulation on STN (Subthalamic Nucleus) target. |
|
| GPi | Active Comparator | Participants were randomized to receive deep brain stimulation on GPi (Globus Pallidus) target. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral Deep Brain Stimulation | Device | The DBS site (STN or GPi) was assigned on a random basis at the time the patient enters the surgical phase of the trial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change From Baseline in the UPDRS-III Score at 24 Months With Deep-brain Stimulation and Without Medication. | The primary outcome measure for the comparison of GPi deep brain stimulation (DBS) to STN DBS is the motor function score of 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. 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. 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. A summary score ranging from 0 to 108 is generated by adding the 14 specific motor function responses. The higher score indicates the worse motor function. | Baseline and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Change From Baseline in the UPDRS Scores Part I (Mentation) at 24 Months. | The UPDRS has four parts (Parts I-IV) in which a total of 42 disease characteristics are assessed. Most characteristics are assessed according to their severity on a 0-4 scale (0 = normal, 4 = most substantial impairment), and some are assessed only for absence (score = 0) or presence (score = 1). Part I has four items assessing intellectual impairment, thought disorder, depression and motivation. A summary score ranging from 0 to16 is generated by adding the four items. The higher score indicates worse condition. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Follett | VA Medical Center, Iowa City | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at Los Angeles | Los Angeles | California | 90073 | United States | ||
| University of California at San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 20519680 |
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299 subjects were enrolled into the study from May 2002 to September 2006 at 13 clinical sites including 7 VA Medical Centers and 6 affiliated university medical centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | STN (Subthalamic Nucleus) 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 | Arm 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Baseline and 24 months |
| The Change From Baseline in the UPDRS Scores Part II (Activity of Daily Living) at 24 Months. | The UPDRS has four parts (Parts I-IV) in which a total of 42 disease characteristics are assessed. Most characteristics are assessed according to their severity on a 0-4 scale (0 = normal, 4 = most substantial impairment), and some are assessed only for absence (score = 0) or presence (score = 1). Part II has 13 items focusing on activities of daily living including walking, writing, dressing and speech. A summary score ranging from 0 to 52 is generated by adding the 13 items. The higher score indicates worse condition. | Baseline and 24 months |
| The Change From Baseline in the UPDRS Scores Part IV (Complication of Therapy) at 24 Months. | The UPDRS has four parts (Parts I-IV) in which a total of 42 disease characteristics are assessed. Most characteristics are assessed according to their severity on a 0-4 scale (0 = normal, 4 = most substantial impairment), and some are assessed only for absence (score = 0) or presence (score = 1). Part IV includes four categories (11 items) related to dyskinesias, clinical fluctuations of symptoms, and other complications. A summary score ranging from 0 to 23 is generated by adding the four items. The higher score indicates worse condition. | Baseline and 24 months |
| San Francisco |
| California |
| 94121 |
| United States |
| VA Medical Center, San Francisco | San Francisco | California | 94121 | 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 | 97207 | United States |
| University of Pennsylvania Hospital | Philadelphia | Pennsylvania | 19104 | United States |
| Philadelphia, OPC | Philadelphia | Pennsylvania | 19106 | 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 | 23249 | United States |
| VA Puget Sound Health Care System, Seattle | Seattle | Washington | 98108 | United States |
| 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. |
| 22722632 | Result | Weaver FM, Follett KA, Stern M, Luo P, Harris CL, Hur K, 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. Randomized trial of deep brain stimulation for Parkinson disease: thirty-six-month outcomes. Neurology. 2012 Jul 3;79(1):55-65. doi: 10.1212/WNL.0b013e31825dcdc1. Epub 2012 Jun 20. |
| 23667214 | Result | 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. |
| 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. |
GPi (Globus Pallidus)
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.
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | STN (Subthalamic Nucleus) 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 | Arm 2 | GPi (Globus Pallidus) 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. |
| 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | The Change From Baseline in the UPDRS Scores Part I (Mentation) at 24 Months. | The UPDRS has four parts (Parts I-IV) in which a total of 42 disease characteristics are assessed. Most characteristics are assessed according to their severity on a 0-4 scale (0 = normal, 4 = most substantial impairment), and some are assessed only for absence (score = 0) or presence (score = 1). Part I has four items assessing intellectual impairment, thought disorder, depression and motivation. A summary score ranging from 0 to16 is generated by adding the four items. The higher score indicates worse condition. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 24 months |
|
|
| |||||||||||||||||||||||||||||
| Primary | The Change From Baseline in the UPDRS-III Score at 24 Months With Deep-brain Stimulation and Without Medication. | The primary outcome measure for the comparison of GPi deep brain stimulation (DBS) to STN DBS is the motor function score of 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. 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. 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. A summary score ranging from 0 to 108 is generated by adding the 14 specific motor function responses. The higher score indicates the worse motor function. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 24 months |
| |||||||||||||||||||||||||||||||
| Secondary | The Change From Baseline in the UPDRS Scores Part II (Activity of Daily Living) at 24 Months. | The UPDRS has four parts (Parts I-IV) in which a total of 42 disease characteristics are assessed. Most characteristics are assessed according to their severity on a 0-4 scale (0 = normal, 4 = most substantial impairment), and some are assessed only for absence (score = 0) or presence (score = 1). Part II has 13 items focusing on activities of daily living including walking, writing, dressing and speech. A summary score ranging from 0 to 52 is generated by adding the 13 items. The higher score indicates worse condition. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 24 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | The Change From Baseline in the UPDRS Scores Part IV (Complication of Therapy) at 24 Months. | The UPDRS has four parts (Parts I-IV) in which a total of 42 disease characteristics are assessed. Most characteristics are assessed according to their severity on a 0-4 scale (0 = normal, 4 = most substantial impairment), and some are assessed only for absence (score = 0) or presence (score = 1). Part IV includes four categories (11 items) related to dyskinesias, clinical fluctuations of symptoms, and other complications. A summary score ranging from 0 to 23 is generated by adding the four items. The higher score indicates worse condition. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 24 months |
|
|
24 months
Adverse events were identified rigorously and categorized as mild, moderate, or severe. Serious adverse events included any event that resulted in death, disability, prolonged or new hospitalization; was life-threatening; or required medical or surgical intervention to prevent one of the above outcomes.
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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 | Arm 1 | STN (Subthalamic Nucleus) 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. | 83 | 147 | 145 | 147 | ||
| EG001 | Arm 2 | GPi (Globus Pallidus) 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. | 77 | 152 | 150 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implantation-site infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Medical device complication | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Lumbar spine stenosis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Mental Status Change | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Adverse Drug Reaction | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Suicidal Depression | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cerebral hemorrhage | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Stroke | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Intracranial Hemorrhage | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| gastrointestinal disorders | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| drug hypersensitivity | Immune system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Road Traffic accidents | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Atrioventricular Block Complete | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Coronary Artery Occlusion | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Coronary Artery Restenosis | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sick Sinus Syndrome | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Appendicitis Perforated | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastric Polyps | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastroduodenitis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hiatus Hernia | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Intestinal Perforation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Oesophageal Spasm | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rectal Hemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Small Instestinal Obstruction | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gait Disturbance | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Implant Site Reaction | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Mechanical Complication of Implant | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Clostridium Difficile Sepsis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Clostridium Difficile Colitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Localized Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sialoadenitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Tooth Abscess | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Freezing Phenomenon | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Aneamia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Visual Disturbance | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| adverse drug reaction | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gait Disturbance | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Implant sight infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Incision Site Pain | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Blood Pressure increase | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Muscle rigidity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Akinesia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bradykinesia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Drooling | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dystonia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| memory Impairment | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Motor Dysfunction | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Poor Quality Sleep | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Speech Disorder | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Abnormal Dreams | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Alcohol Abuse | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sexual Dysfunction | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dyspnonea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Orthostatic Hypotension | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
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We observed differences between STN and GPi DBS groups on several secondary measures but these findings should be interpreted cautiously. We did not adjust for repeated significance tests and the differences may have limited clinical significance.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frances M. Weaver, Ph.D | Hines Veterans Affairs Hospital Center for Management of Complex Chronic Care | 708-202-8387 | 25866 | 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 |
Not provided
Not provided
| >=65 years |
|
| Male |
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| Participants |
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