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The purpose of this post-market study is to characterize the clinical performance of the Infinity Deep Brain Stimulation (DBS) system, including the Implantable Pulse Generator (IPG), directional DBS leads, extensions, iPad clinician programmer, iPod patient controller and related system components.
Participants in the PROGRESS study are not assigned to interventional therapy groups. Participants in the PROGRESS study are followed in an observational format as they receive omnidirectional and then directional DBS programming that is part of routine medical care. Data on symptoms are collected during two different stages of programming, and those outcomes compared to assess the effect of omnidirectional or directional programming.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omnidirectional followed by directional DBS | Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for months 3-6 in all subjects with a directional DBS lead. Primary end point is based on double-blind testing of omnidirectional vs. directional DBS in randomized order at 3-month follow-up visit. In this Observational study design, all interventions here are therapeutic interventions that are part of the standard of care, rather than assigned as part of an interventional study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omnidirectional stimulation | Device | At the 3-month follow-up, therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional stimulation with the Infinity DBS lead. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Superiority) | Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. Proportion of subjects with a wider therapeutic window using directional stimulation, compared to a threshold of 60%. Based on randomized, double-blind evaluation using within-subject control. | 3-month follow-up visit after initial programming |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Non-Inferiority) | Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. The proportion of subjects with wider therapeutic window using directional stimulation will be compared to a performance goal of 60% with a non-inferiority threshold of 40%. Based on randomized, double-blind evaluation using within-subject control. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who have a diagnosis matching the approved indication and are being considered for a DBS implant or who have been implanted with an Infinity System comprise the target population for this study. All subjects who meet the inclusion and none of the exclusion criteria and have signed an Ethics Committee (EC) or Institutional Review Board (IRB) approved informed consent will be considered enrolled in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Alfons Schnitzler, MD | Heinrich-Heine-Universität Düsseldorf, Institute for Clinical Neuroscience | Principal Investigator |
| Jan Vesper, MD | Heinrich-Heine-Universität Düsseldorf, Department of Functional and Stereotactic Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Sacramento Medical Center | Sacramento | California | 95825 | United States | ||
| University of Colorado Hospital |
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This prospective, blinded-subject, blinded-evaluator, observational, multi-center 12-month post-market clinical follow-up study study enrolled a total of 234 participants between January 2017 and January 2019 at 37 sites in Europe, the U.S. and Australia. Of which 82 participants completed 36 months follow-up visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Omnidirectional Followed by Directional DBS | Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for the following three months up to 6 months, unless not tolerated. At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 25, 2019 |
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| Directional stimulation | Device | At the 3-month follow-up, therapeutic window, symptom relief and side effect thresholds are evaluated using directional contacts at the best segmented level of the Infinity DBS lead. |
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| 3-month follow-up visit after initial programming |
| Change In UPDRS III Score On and Off Stimulation (Medication On) at 3 and 6 Months | Change with stimulation on vs. off in Unified Parkinson's Disease Rating Scale (UPDRS) part III motor examination at 3 months using omnidirectional stimulation, compared to 6 months using directional stimulation. UPDRS part III contains 27 questions used to measures severity of Parkinson's motor symptoms. The range of scores is 0 to 108, with higher score indicating greater symptoms. Subjects are on medication for the assessment. | 3 and 6 Months Follow-Up Visits |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Shands at University of Florida | Gainesville | Florida | 32610 | United States |
| University of Miami Hospital | Miami | Florida | 33136 | United States |
| Rush University, Department of Neurological Sciences | Chicago | Illinois | 60612 | United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| Johns Hopkins University Hospital | Baltimore | Maryland | 21287 | United States |
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| New York University Langone Medical Center - Tisch Hospital | New York | New York | 10016 | United States |
| Mount Sinai Hospital | New York | New York | 10019 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State Medical | Columbus | Ohio | 43210 | United States |
| Oregon Health and Science University, Department of Neurology | Portland | Oregon | 97239 | United States |
| St. Luke's Hospital & Health Network | Bethlehem | Pennsylvania | 18015 | United States |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Allegheny General Hospital - ASRI | Pittsburgh | Pennsylvania | 15212 | United States |
| Neurology Consultants of Dallas | Dallas | Texas | 75251 | United States |
| CHI St. Luke's Health Baylor College of Medicine Medical Center | Houston | Texas | 77030 | United States |
| Abbott, Medical and Clinical Affairs | Plano | Texas | 75024 | United States |
| Princess Alexandra Hospital | Brisbane | 4102 | Australia |
| Royal Melbourne Hospital - City Campus | Melbourne | 3050 | Australia |
| Westmead Hospital | Richmond | 2145 | Australia |
| UZ Gent | Ghent | 42100 | Belgium |
| Carl Gustav Carus Dresden an der Technischen | Dresden | 1307 | Germany |
| Heinrich Heine University of Düsseldorf, Department of Neurology | Düsseldorf | 40225 | Germany |
| Heinrich-Heine-Universität Düsseldorf, Department of Functional and Stereotactic Neurosurgery | Düsseldorf | Germany |
| UKE Hamburg | Hamburg | 20246 | Germany |
| Johannes Gutenberg-University of Mainz | Mainz | 55131 | Germany |
| Klinikum der Universität Regensburg | Regensburg | 93053 | Germany |
| IRCCS Istituto Ortopedico Galeazzi | Milan | 20161 | Italy |
| Fondazione Istituto Neurologico Nazionale C. Mondino | Pavia | 27100 | Italy |
| Azienda Ospedaliero-Universitaria S Maria della Misericordia | Udine | 33100 | Italy |
| Copernicus Hospital, Department of Neurosurgery, | Gdansk | 80-803 | Poland |
| Oncology Center- Marie Curie Institute | Warsaw | 02-781 | Poland |
| Institute of Psychiatry and Neurology | Warsaw | 02-957 | Poland |
| Hospital Universitari Germans Trias I Pujol | Badalona | 08916 | Spain |
| Hospital Universitario Central de Asturias, Department of Neurology, | Oviedo | 33011 | Spain |
| Hospital Universitario Virgen del Rocío, Department of Neurology | Seville | 41013 | Spain |
| The Walton Centre | Liverpool | L9 7LJ | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| BG000 | Omnidirectional Followed by Directional DBS | Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for the following three months up to 6 months, unless not tolerated. At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
| ||||||||||||||||||
| Duration of Parkinson Symptoms | Mean | Standard Deviation | Years |
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| 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 | Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Superiority) | Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. Proportion of subjects with a wider therapeutic window using directional stimulation, compared to a threshold of 60%. Based on randomized, double-blind evaluation using within-subject control. | The number of participants analyzed includes subjects for whom data were available at that time of analysis. | Posted | Count of Participants | Participants | 3-month follow-up visit after initial programming |
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| Secondary | Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Non-Inferiority) | Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. The proportion of subjects with wider therapeutic window using directional stimulation will be compared to a performance goal of 60% with a non-inferiority threshold of 40%. Based on randomized, double-blind evaluation using within-subject control. | The number of participants analyzed includes subjects for whom data were available at that time of analysis. | Posted | Count of Participants | Participants | 3-month follow-up visit after initial programming |
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| Secondary | Change In UPDRS III Score On and Off Stimulation (Medication On) at 3 and 6 Months | Change with stimulation on vs. off in Unified Parkinson's Disease Rating Scale (UPDRS) part III motor examination at 3 months using omnidirectional stimulation, compared to 6 months using directional stimulation. UPDRS part III contains 27 questions used to measures severity of Parkinson's motor symptoms. The range of scores is 0 to 108, with higher score indicating greater symptoms. Subjects are on medication for the assessment. | The number of participants analyzed includes subjects for whom data were available at that time of analysis. | Posted | Mean | Standard Deviation | Score on a scale | 3 and 6 Months Follow-Up Visits |
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36 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 | Omnidirectional Followed by Directional DBS | Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for the following three months up to 6 months, unless not tolerated. At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead. | 3 | 234 | 34 | 234 | 32 | 234 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Vein Thrombosis | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Edema | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Traumatic Psoas Bleed | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Endocrinological Issues | Endocrine disorders | MedDRA 11.0 | Systematic Assessment |
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| Appendicitis with Perforation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Umbilical Hernia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Chest Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Coma Related to Drowning | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Fall at Home | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Fracture of Vertebrae | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Several Falls | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Spinal Cord Canal Stenosis | General disorders | MedDRA 11.0 | Systematic Assessment |
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| TLOC (Transient Loss of Consciousness) | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Sepsis Secondary to Influenza Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Battery Failure Within the Device | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Extension Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Lead Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Loss of Therapeutic Benefit - Change in Electrode Positions | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Speech or Language Impairment - Aphasia | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Speech or Language Impairment - Dysphagia | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Dystonia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Basal Cell Carcinoma of Scalp and Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
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| Worsening of Motor/Parkinson's Disease Symptoms - Abnormal Gait | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Worsening of Motor/Parkinson's Disease Symptoms - Tremor | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Cognitive impairment - Confusion | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Cognitive impairment - Disorientation | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Dopamine Dysregulation Syndrome | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Suicide | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
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| Renal Stones with Secondary Sepsis | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
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| Acute Hypoxic Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Erosion | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Erosion Due to Undiagnosed Dermatologic Disorder | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Bioprosthetic Av Replacement | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Battery Failure Within the Device | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Cognitive Impairment - Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Cognitive Impairment - Emotional Lability | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Cognitive Impairment - Hallucinations | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Decreased Therapeutic Response | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Deep Brain Stimulation System Malfunction | Product Issues | MedDRA 11.0 | Systematic Assessment |
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| Dyskinetic Dystonia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Dystonia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Headache/Migraine | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Impaired Wound Healing - Incision Site Drainage | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Loss of Therapeutic Benefit - Change in Loose Electrical Connections | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Persistent Pain at Surgery Site or Ipg Site | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
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| Sensory Disturbance or Impairment - Neuralgia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Sensory Disturbance or Impairment - Sensory Deficit | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Shortness of Breath On Exertion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Skull Discoloration | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Speech or Language Impairment - Dysarthria | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Sub-Optimal Placement of Lead | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Undesirable Changes in Stimulation - Other | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Worsening of Motor/Parkinson's Disease Symptoms - Abnormal Gait | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Worsening of Motor/Parkinson's Disease Symptoms - Bradykinesia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Worsening of Motor/Parkinson's Disease Symptoms - Dyskinesia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Worsening of Motor/Parkinson's Disease Symptoms - Motor Fluctuations | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Worsening of Motor/Parkinson's Disease Symptoms - Rigidity | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Worsening of Motor/Parkinson's Disease Symptoms - Tremor | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tucker Tomlinson, Scientist, Clinical Research | Abbott | +19725269646 | Tucker.Tomlinson@Abbott.com |
| Feb 21, 2024 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| 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 |
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