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The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.
ADROIT is an international, prospective, multicenter, observational, post-market study intended to collect worldwide long-term safety and effectiveness data on subjects implanted with market-released Abbott DBS systems in routine clinical practice.
Subjects will be followed for 5 years after the initial programming visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep brain stimulation | Subjects implanted with an Abbott DBS system |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Brain Stimulation (DBS) | Device | Deep brain stimulation therapy involves the delivery of electrical signals to targeted structures in the brain to modulate neural circuit activity, and has been used successfully for the treatment of various types of movement disorders, including Parkinson's disease (PD), disabling or essential tremor, and dystonia |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to 6 months in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. | The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assess the severity of Parkinson's disease. This questionnaire is composed of four sections: Part I: non-motor experiences of daily living consisting of 13 questions (Part Ia is assessed by the investigator while part Ib is assessed by the subject, with or without the help of the caregiver); Part II: motor experiences of daily living consisting of 13 questions, designed to be self-administered; Part III: motor examinations consisting of 33 scores based on 18 questions with several right, left or other body distribution scores; Part IV: motor complications: consisting of 6 questions. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score for each part is obtained from the sum of the corresponding item scores. Higher scores indicate greater impact of PD symptoms. | Baseline to 6 months |
| Change from baseline to1 year in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. | The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assess the severity of Parkinson's disease. This questionnaire is composed of four sections: Part I: non-motor experiences of daily living consisting of 13 questions (Part Ia is assessed by the investigator while part Ib is assessed by the subject, with or without the help of the caregiver); Part II: motor experiences of daily living consisting of 13 questions, designed to be self-administered; Part III: motor examinations consisting of 33 scores based on 18 questions with several right, left or other body distribution scores; Part IV: motor complications: consisting of 6 questions. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score for each part is obtained from the sum of the corresponding item scores. Higher scores indicate greater impact of PD symptoms. | Baseline to1 year |
| Change from baseline to 2 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. |
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Inclusion Criteria:
Exclusion Criteria:
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This study will enroll male and female subjects diagnosed with Parkinson's disease, essential tremor or other disabling tremor, or dystonia who are scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudia Salazar, PhD | Contact | +1-650-647-3396 | claudia.salazar4@abbott.com | |
| Shirisha Chiluka | Contact | 972-526-4820 | Shirisha.Chiluka@abbott.com |
| Name | Affiliation | Role |
|---|---|---|
| Devyani Nanduri | Abbott Medical Devices Neuromodulation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Aizona Health Sciences | Active, not recruiting | Tucson | Arizona | 85274 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41535352 | Derived | Gharabaghi A, Groppa S, Casas E, Schnitzler A, Munoz-Delgado L, Marshall VL, Karl J, Zhang L, Alvarez R, Feldman MS, Soileau MJ, Luo L, Walter BL, Wu C, Lei H, Herz DM, Nanduri D, Salazar CA, Luca C, Weiss D. Real-world multicenter assessment of sustained clinical outcomes after digital deep brain stimulation. NPJ Digit Med. 2026 Jan 14;9(1):133. doi: 10.1038/s41746-025-02315-5. |
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The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assess the severity of Parkinson's disease. This questionnaire is composed of four sections: Part I: non-motor experiences of daily living consisting of 13 questions (Part Ia is assessed by the investigator while part Ib is assessed by the subject, with or without the help of the caregiver); Part II: motor experiences of daily living consisting of 13 questions, designed to be self-administered; Part III: motor examinations consisting of 33 scores based on 18 questions with several right, left or other body distribution scores; Part IV: motor complications: consisting of 6 questions. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score for each part is obtained from the sum of the corresponding item scores. Higher scores indicate greater impact of PD symptoms. |
| Baseline to 2 years |
| Change from baseline to 3 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. | The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assess the severity of Parkinson's disease. This questionnaire is composed of four sections: Part I: non-motor experiences of daily living consisting of 13 questions (Part Ia is assessed by the investigator while part Ib is assessed by the subject, with or without the help of the caregiver); Part II: motor experiences of daily living consisting of 13 questions, designed to be self-administered; Part III: motor examinations consisting of 33 scores based on 18 questions with several right, left or other body distribution scores; Part IV: motor complications: consisting of 6 questions. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score for each part is obtained from the sum of the corresponding item scores. Higher scores indicate greater impact of PD symptoms. | Baseline to 3 years |
| Change from baseline to 4 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. | The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assess the severity of Parkinson's disease. This questionnaire is composed of four sections: Part I: non-motor experiences of daily living consisting of 13 questions (Part Ia is assessed by the investigator while part Ib is assessed by the subject, with or without the help of the caregiver); Part II: motor experiences of daily living consisting of 13 questions, designed to be self-administered; Part III: motor examinations consisting of 33 scores based on 18 questions with several right, left or other body distribution scores; Part IV: motor complications: consisting of 6 questions. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score for each part is obtained from the sum of the corresponding item scores. Higher scores indicate greater impact of PD symptoms. | Baseline to 4 years |
| Change from baseline to 5 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. | The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assess the severity of Parkinson's disease. This questionnaire is composed of four sections: Part I: non-motor experiences of daily living consisting of 13 questions (Part Ia is assessed by the investigator while part Ib is assessed by the subject, with or without the help of the caregiver); Part II: motor experiences of daily living consisting of 13 questions, designed to be self-administered; Part III: motor examinations consisting of 33 scores based on 18 questions with several right, left or other body distribution scores; Part IV: motor complications: consisting of 6 questions. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score for each part is obtained from the sum of the corresponding item scores. Higher scores indicate greater impact of PD symptoms. | Baseline to 5 years |
| Change from baseline to 6 months in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. | The Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) assesses tremor severity and and consists of three parts. Part A (with a maximum score of 80) rates tremor at rest, during posture, and intentional movements for nine parts of the body, including the head, trunk and limbs; Part B (with a maximum score of 36) rates action tremor of the upper limbs, particularly while writing and pouring liquids; part C the patient rates the impact of tremor on his or her functional disability (speaking, feeding, drinking, hygiene, dressing, writing, and working) with a maximum score of 28. The total score obtained by adding the three parts of the FTM-TRS is 144, with a higher score indicating higher disease severity/disability. The FTM-TRS also includes one separate item dealing with global assessment of tremor-related disability, rated by both patient and examiner on a 5-point scale. | Baseline to 6 months |
| Change from baseline to 1 year in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. | The Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) assesses tremor severity and and consists of three parts. Part A (with a maximum score of 80) rates tremor at rest, during posture, and intentional movements for nine parts of the body, including the head, trunk and limbs; Part B (with a maximum score of 36) rates action tremor of the upper limbs, particularly while writing and pouring liquids; part C the patient rates the impact of tremor on his or her functional disability (speaking, feeding, drinking, hygiene, dressing, writing, and working) with a maximum score of 28. The total score obtained by adding the three parts of the FTM-TRS is 144, with a higher score indicating higher disease severity/disability.The FTM-TRS also includes one separate item dealing with global assessment of tremor-related disability, rated by both patient and examiner on a 5-point scale. | Baseline to 1 year |
| Change from baseline to 2 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. | The Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) assesses tremor severity and and consists of three parts. Part A (with a maximum score of 80) rates tremor at rest, during posture, and intentional movements for nine parts of the body, including the head, trunk and limbs; Part B (with a maximum score of 36) rates action tremor of the upper limbs, particularly while writing and pouring liquids; part C the patient rates the impact of tremor on his or her functional disability (speaking, feeding, drinking, hygiene, dressing, writing, and working) with a maximum score of 28. The total score obtained by adding the three parts of the FTM-TRS is 144, with a higher score indicating higher disease severity/disability.The FTM-TRS also includes one separate item dealing with global assessment of tremor-related disability, rated by both patient and examiner on a 5-point scale. | Baseline to 2 years |
| Change from baseline to 3 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. | The Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) assesses tremor severity and and consists of three parts. Part A (with a maximum score of 80) rates tremor at rest, during posture, and intentional movements for nine parts of the body, including the head, trunk and limbs; Part B (with a maximum score of 36) rates action tremor of the upper limbs, particularly while writing and pouring liquids; part C the patient rates the impact of tremor on his or her functional disability (speaking, feeding, drinking, hygiene, dressing, writing, and working) with a maximum score of 28. The total score obtained by adding the three parts of the FTM-TRS is 144, with a higher score indicating higher disease severity/disability.The FTM-TRS also includes one separate item dealing with global assessment of tremor-related disability, rated by both patient and examiner on a 5-point scale. | Baseline to 3 years |
| Change from baseline to 4 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. | The Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) assesses tremor severity and and consists of three parts. Part A (with a maximum score of 80) rates tremor at rest, during posture, and intentional movements for nine parts of the body, including the head, trunk and limbs; Part B (with a maximum score of 36) rates action tremor of the upper limbs, particularly while writing and pouring liquids; part C the patient rates the impact of tremor on his or her functional disability (speaking, feeding, drinking, hygiene, dressing, writing, and working) with a maximum score of 28. The total score obtained by adding the three parts of the FTM-TRS is 144, with a higher score indicating higher disease severity/disability. The FTM-TRS also includes one separate item dealing with global assessment of tremor-related disability, rated by both patient and examiner on a 5-point scale. | Baseline to 4 years |
| Change from baseline to 5 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. | The Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) assesses tremor severity and and consists of three parts. Part A (with a maximum score of 80) rates tremor at rest, during posture, and intentional movements for nine parts of the body, including the head, trunk and limbs; Part B (with a maximum score of 36) rates action tremor of the upper limbs, particularly while writing and pouring liquids; part C the patient rates the impact of tremor on his or her functional disability (speaking, feeding, drinking, hygiene, dressing, writing, and working) with a maximum score of 28. The total score obtained by adding the three parts of the FTM-TRS is 144, with a higher score indicating higher disease severity/disability.The FTM-TRS also includes one separate item dealing with global assessment of tremor-related disability, rated by both patient and examiner on a 5-point scale. | Baseline to 5 years |
| Change from baseline to 6 months in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale. | The BFMDRS consists consists of a movement subscale and a disability subscale. The movement scale measures dystonia in nine body regions (including the eyes, mouth, speech and swallowing, neck, trunk, arms, and legs). Each domain is scored on degree of provoking factor (0=no dystonia at rest or with action to 4=dystonia present at rest) and severity factor (0=no dystonia to 4=extreme/severe dystonia). Scores are weighted yielding a total score ranging from 0 to 120. The disability scale is a functional marker consisting of parental- or self-reported daily activities (involving speech, handwriting, feeding, eating, swallowing, hygiene, dressing, and walking), with scores ranging from 0 (completely independent) to 30 (completely dependent). A higher score indicates higher disease severity/disability. | Baseline to 6 months |
| Change from baseline to 1 year in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale. | The BFMDRS consists consists of a movement subscale and a disability subscale. The movement scale measures dystonia in nine body regions (including the eyes, mouth, speech and swallowing, neck, trunk, arms, and legs). Each domain is scored on degree of provoking factor (0=no dystonia at rest or with action to 4=dystonia present at rest) and severity factor (0=no dystonia to 4=extreme/severe dystonia). Scores are weighted yielding a total score ranging from 0 to 120. The disability scale is a functional marker consisting of parental- or self-reported daily activities (involving speech, handwriting, feeding, eating, swallowing, hygiene, dressing, and walking), with scores ranging from 0 (completely independent) to 30 (completely dependent). A higher score indicates higher disease severity/disability. | Baseline to 1 year |
| Change from baseline to 2 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale. | The BFMDRS consists consists of a movement subscale and a disability subscale. The movement scale measures dystonia in nine body regions (including the eyes, mouth, speech and swallowing, neck, trunk, arms, and legs). Each domain is scored on degree of provoking factor (0=no dystonia at rest or with action to 4=dystonia present at rest) and severity factor (0=no dystonia to 4=extreme/severe dystonia). Scores are weighted yielding a total score ranging from 0 to 120. The disability scale is a functional marker consisting of parental- or self-reported daily activities (involving speech, handwriting, feeding, eating, swallowing, hygiene, dressing, and walking), with scores ranging from 0 (completely independent) to 30 (completely dependent). A higher score indicates higher disease severity/disability. | Baseline to 2 years |
| Change from baseline to 3 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale. | The BFMDRS consists consists of a movement subscale and a disability subscale. The movement scale measures dystonia in nine body regions (including the eyes, mouth, speech and swallowing, neck, trunk, arms, and legs). Each domain is scored on degree of provoking factor (0=no dystonia at rest or with action to 4=dystonia present at rest) and severity factor (0=no dystonia to 4=extreme/severe dystonia). Scores are weighted yielding a total score ranging from 0 to 120. The disability scale is a functional marker consisting of parental- or self-reported daily activities (involving speech, handwriting, feeding, eating, swallowing, hygiene, dressing, and walking), with scores ranging from 0 (completely independent) to 30 (completely dependent). A higher score indicates higher disease severity/disability. | Baseline to 3 years |
| Change from baseline to 4 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale. | The BFMDRS consists consists of a movement subscale and a disability subscale. The movement scale measures dystonia in nine body regions (including the eyes, mouth, speech and swallowing, neck, trunk, arms, and legs). Each domain is scored on degree of provoking factor (0=no dystonia at rest or with action to 4=dystonia present at rest) and severity factor (0=no dystonia to 4=extreme/severe dystonia). Scores are weighted yielding a total score ranging from 0 to 120. The disability scale is a functional marker consisting of parental- or self-reported daily activities (involving speech, handwriting, feeding, eating, swallowing, hygiene, dressing, and walking), with scores ranging from 0 (completely independent) to 30 (completely dependent). A higher score indicates higher disease severity/disability. | Baseline to 4 years |
| Change from baseline to 5 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale. | The BFMDRS consists consists of a movement subscale and a disability subscale. The movement scale measures dystonia in nine body regions (including the eyes, mouth, speech and swallowing, neck, trunk, arms, and legs). Each domain is scored on degree of provoking factor (0=no dystonia at rest or with action to 4=dystonia present at rest) and severity factor (0=no dystonia to 4=extreme/severe dystonia). Scores are weighted yielding a total score ranging from 0 to 120. The disability scale is a functional marker consisting of parental- or self-reported daily activities (involving speech, handwriting, feeding, eating, swallowing, hygiene, dressing, and walking), with scores ranging from 0 (completely independent) to 30 (completely dependent). A higher score indicates higher disease severity/disability. | Baseline to 5 years |
| Change from baseline to 6 months in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale. | The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale rates the severity of cervical dystonia. This scale consists of three subscales measuring symptom severity, disability, and pain. The severity scale is rated by the clinician and is composed of 11 items with a maximum score of 35. The disability and pain scales are patient-rated. The disability scale is composed of 6 items with a maximum score of 30. The pain scale is composed of 3 items with a maximum score of 20. The total TWSTRS score ranges from 0 to 85 points. Higher scores indicate higher severity/disability/pain. | Baseline to 6 months |
| Change from baseline to 1 year in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale. | The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale rates the severity of cervical dystonia. This scale consists of three subscales measuring symptom severity, disability, and pain. The severity scale is rated by the clinician and is composed of 11 items with a maximum score of 35. The disability and pain scales are patient-rated. The disability scale is composed of 6 items with a maximum score of 30. The pain scale is composed of 3 items with a maximum score of 20. The total TWSTRS score ranges from 0 to 85 points. Higher scores indicate higher severity/disability/pain. | Baseline to 1 year |
| Change from baseline to 2 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale. | The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale rates the severity of cervical dystonia. This scale consists of three subscales measuring symptom severity, disability, and pain. The severity scale is rated by the clinician and is composed of 11 items with a maximum score of 35. The disability and pain scales are patient-rated. The disability scale is composed of 6 items with a maximum score of 30. The pain scale is composed of 3 items with a maximum score of 20. The total TWSTRS score ranges from 0 to 85 points. Higher scores indicate higher severity/disability/pain. | Baseline to 2 years |
| Change from baseline to 3 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale. | The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale rates the severity of cervical dystonia. This scale consists of three subscales measuring symptom severity, disability, and pain. The severity scale is rated by the clinician and is composed of 11 items with a maximum score of 35. The disability and pain scales are patient-rated. The disability scale is composed of 6 items with a maximum score of 30. The pain scale is composed of 3 items with a maximum score of 20. The total TWSTRS score ranges from 0 to 85 points. Higher scores indicate higher severity/disability/pain. | Baseline to 3 years |
| Change from baseline to 4 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale. | The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale rates the severity of cervical dystonia. This scale consists of three subscales measuring symptom severity, disability, and pain. The severity scale is rated by the clinician and is composed of 11 items with a maximum score of 35. The disability and pain scales are patient-rated. The disability scale is composed of 6 items with a maximum score of 30. The pain scale is composed of 3 items with a maximum score of 20. The total TWSTRS score ranges from 0 to 85 points. Higher scores indicate higher severity/disability/pain. | Baseline to 4 years |
| Change from baseline to 5 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale. | The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale rates the severity of cervical dystonia. This scale consists of three subscales measuring symptom severity, disability, and pain. The severity scale is rated by the clinician and is composed of 11 items with a maximum score of 35. The disability and pain scales are patient-rated. The disability scale is composed of 6 items with a maximum score of 30. The pain scale is composed of 3 items with a maximum score of 20. The total TWSTRS score ranges from 0 to 85 points. Higher scores indicate higher severity/disability/pain. | Baseline to 5 years |
| Incidence of device- and procedure-related serious adverse events at 6 months | Serious Adverse Events related to the device and procedure will be assessed. If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE). a) Led to a death, b) Led to a serious deterioration in health of the subject, that either resulted in i) a life-threatening illness or injury, or ii) a permanent impairment of a body structure or a body function, or iii) in-patient hospitalization or prolongation of existing hospitalization, or iv) medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function. v) chronic disease c) Led to fetal distress, fetal death or a congenital abnormality or birth defect. | At 6 months |
| Incidence of device- and procedure-related serious adverse events at 1 year | Serious Adverse Events related to the device and procedure will be assessed. If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE). a) Led to a death, b) Led to a serious deterioration in health of the subject, that either resulted in i) a life-threatening illness or injury, or ii) a permanent impairment of a body structure or a body function, or iii) in-patient hospitalization or prolongation of existing hospitalization, or iv) medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function. v) chronic disease c) Led to fetal distress, fetal death or a congenital abnormality or birth defect. | At 1 year |
| Incidence of device- and procedure-related serious adverse events at 2 years | Serious Adverse Events related to the device and procedure will be assessed. If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE). a) Led to a death, b) Led to a serious deterioration in health of the subject, that either resulted in i) a life-threatening illness or injury, or ii) a permanent impairment of a body structure or a body function, or iii) in-patient hospitalization or prolongation of existing hospitalization, or iv) medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function. v) chronic disease c) Led to fetal distress, fetal death or a congenital abnormality or birth defect. | At 2 years |
| Incidence of device- and procedure-related serious adverse events at 3 years | Serious Adverse Events related to the device and procedure will be assessed. If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE). a) Led to a death, b) Led to a serious deterioration in health of the subject, that either resulted in i) a life-threatening illness or injury, or ii) a permanent impairment of a body structure or a body function, or iii) in-patient hospitalization or prolongation of existing hospitalization, or iv) medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function. v) chronic disease c) Led to fetal distress, fetal death or a congenital abnormality or birth defect. | At 3 years |
| Incidence of device- and procedure-related serious adverse events at 4 years | Serious Adverse Events related to the device and procedure will be assessed. If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE). a) Led to a death, b) Led to a serious deterioration in health of the subject, that either resulted in i) a life-threatening illness or injury, or ii) a permanent impairment of a body structure or a body function, or iii) in-patient hospitalization or prolongation of existing hospitalization, or iv) medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function. v) chronic disease c) Led to fetal distress, fetal death or a congenital abnormality or birth defect. | At 4 years |
| Incidence of device- and procedure-related serious adverse events at 5 years | Serious Adverse Events related to the device and procedure will be assessed. If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE). a) Led to a death, b) Led to a serious deterioration in health of the subject, that either resulted in i) a life-threatening illness or injury, or ii) a permanent impairment of a body structure or a body function, or iii) in-patient hospitalization or prolongation of existing hospitalization, or iv) medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function. v) chronic disease c) Led to fetal distress, fetal death or a congenital abnormality or birth defect. | At 5 years |
| Cedars-Sinai Medical Center |
| Active, not recruiting |
| Los Angeles |
| California |
| 90048 |
| United States |
| University of California at Davis | Active, not recruiting | Sacramento | California | 95817 | United States |
| Colorado Neurodiagnostics | Terminated | Littleton | Colorado | 80120 | United States |
| Neurosurgery One | Withdrawn | Littleton | Colorado | 80122 | United States |
| University of Miami Hospital | Active, not recruiting | Miami | Florida | 33136 | United States |
| University of South Florida - Department of Neurology | Recruiting | Tampa | Florida | 33612 | United States |
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| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
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| Indiana University | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| Kansas University Medical Center | Active, not recruiting | Kansas City | Kansas | 66160 | United States |
| University of Louisville | Recruiting | Louisville | Kentucky | 40202 | United States |
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| Willis-Knighton Medical Center | Terminated | Shreveport | Louisiana | 71103 | United States |
| Beth Israe Deaconess Medical Center | Active, not recruiting | Boston | Massachusetts | 02215 | United States |
| Dartmouth Hitchcock Medical Center | Active, not recruiting | Lebanon | New Hampshire | 03756 | United States |
| Albany Medical Center | Recruiting | Albany | New York | 12208 | United States |
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| The Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44106 | United States |
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| Ohio State Medical | Recruiting | Columbus | Ohio | 43210 | United States |
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| Wright State University & Premier Health | Withdrawn | Fairborn | Ohio | 45324 | United States |
| Center for Interventional Pain & Spine | Withdrawn | Exton | Pennsylvania | 19341 | United States |
| Thomas Jefferson Department or Neurosurgery | Active, not recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Allegheny General Hospital Department of Neurosurgery | Terminated | Pittsburgh | Pennsylvania | 15212 | United States |
| Texas Movement Disorder Specialist | Active, not recruiting | Georgetown | Texas | 78628 | United States |
| University of Utah Hospital | Recruiting | Salt Lake City | Utah | 84132 | United States |
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| Princess Alexandra Hospital | Recruiting | Woolloongabba | Queensland | 4102 | Australia |
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| Royal Melbourne Hospital - City Campus | Recruiting | Parkville | Victoria | 3050 | Australia |
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| Helsinki University Central Hospital | Recruiting | Helsinki | Uusimaa | 00290 | Finland |
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| CHU Gabriel Montpied | Withdrawn | Clermont-Ferrand | Auvergne | 63003 | France |
| CHU de St Etienne | Active, not recruiting | Saint-Etienne | Auvergne | 42270 | France |
| Fondation Rothchild | Withdrawn | Paris | ILE | France |
| CHU Hopital Pasteur | Recruiting | Nice | Provence-Alpes-Azur | 6002 | France |
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| Universitäts Klinikum Tübingen | Recruiting | Tübingen | Baden-Wurttemberg | 72076 | Germany |
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| Medizinische Einrichtungen der Universität Düsseldorf | Recruiting | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
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| Universitätsklinikum Münster | Recruiting | Münster | North Rhine-Westphalia | 48149 | Germany |
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| UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz | Recruiting | Mainz | Rhineland-Palatinate | 55131 | Germany |
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| Universitätsklinikum des Saarlandes | Recruiting | Homburg | Saarland | 66421 | Germany |
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| UKE Hamburg (Universitatsklinik Eppendorf) | Active, not recruiting | Hamburg | 20246 | Germany |
| Az.Osp. Universitaria di Ferrara | Terminated | Cona | Emilia-Romagna | 44124 | Italy |
| Policlinico Universitario A. Gemelli | Recruiting | Rome | Lazio | 00618 | Italy |
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| Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | Active, not recruiting | Milan | Lombardy | 20133 | Italy |
| Hospital Virgen de Rocio | Recruiting | Seville | Andalusia | 41013 | Spain |
|
| Hospital Universitari Germans Trias I Pujol | Recruiting | Badalona | Catalonia | 08916 | Spain |
|
| Hospital Universitario de la Princesa | Recruiting | Madrid | 28006 | Spain |
|
| Chang Gung Memorial Hospital | Active, not recruiting | Linkou District | Ntaiwan | 333 | Taiwan |
| Hualien Tzu Chi Hospital | Recruiting | Hualien City | 97002 | Taiwan |
|
| The Walton Centre | Active, not recruiting | Liverpool | North West England | L9 7LJ | United Kingdom |
| Southmead Hospita | Withdrawn | Bristol | South West England | BS10 5NB | United Kingdom |
| Queen Elizabeth University Hospital | Recruiting | Glasgow | Wdbtshr | United Kingdom |
|
| King's College Hospital | Recruiting | London | SE5 9RS | United Kingdom |
|
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D010300 | Parkinson Disease |
| D020329 | Essential Tremor |
| D014202 | Tremor |
| D004421 | Dystonia |
| D020821 | Dystonic Disorders |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided