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Abbott DBS Post-Market Study of Outcomes for Indications Over Time (ADROIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04071847
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : May 5, 2022
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
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.

Condition or disease Intervention/treatment
Movement Disorders Parkinson Disease Essential Tremor Tremor Dystonia Primary Dystonia Secondary Dystonia Device: Deep Brain Stimulation (DBS)

Detailed Description:

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Abbott DBS Post-Market Study of Outcomes for Indications Over Time
Actual Study Start Date : November 26, 2019
Estimated Primary Completion Date : September 2029
Estimated Study Completion Date : September 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Group/Cohort Intervention/treatment
Deep brain stimulation
Subjects implanted with an Abbott DBS system
Device: Deep Brain Stimulation (DBS)
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




Primary Outcome Measures :
  1. Change from baseline to 6 months in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. [ Time Frame: Baseline to 6 months ]
    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.

  2. Change from baseline to1 year in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. [ Time Frame: Baseline to1 year ]
    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.

  3. Change from baseline to 2 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. [ Time Frame: Baseline to 2 years ]
    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.

  4. Change from baseline to 3 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. [ Time Frame: Baseline to 3 years ]
    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.

  5. Change from baseline to 4 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. [ Time Frame: Baseline to 4 years ]
    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.

  6. Change from baseline to 5 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. [ Time Frame: Baseline to 5 years ]
    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.

  7. Change from baseline to 6 months in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. [ Time Frame: Baseline to 6 months ]

    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.


  8. Change from baseline to 1 year in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. [ Time Frame: Baseline to 1 year ]
    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.

  9. Change from baseline to 2 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. [ Time Frame: Baseline to 2 years ]
    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.

  10. Change from baseline to 3 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. [ Time Frame: Baseline to 3 years ]
    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.

  11. Change from baseline to 4 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. [ Time Frame: Baseline to 4 years ]
    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.

  12. Change from baseline to 5 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. [ Time Frame: Baseline to 5 years ]
    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.

  13. Change from baseline to 6 months in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale. [ Time Frame: Baseline to 6 months ]
    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.

  14. Change from baseline to 1 year in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale. [ Time Frame: Baseline to 1 year ]
    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.

  15. Change from baseline to 2 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale. [ Time Frame: Baseline to 2 years ]
    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.

  16. Change from baseline to 3 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale. [ Time Frame: Baseline to 3 years ]
    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.

  17. Change from baseline to 4 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale. [ Time Frame: Baseline to 4 years ]
    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.

  18. Change from baseline to 5 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale. [ Time Frame: Baseline to 5 years ]
    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.

  19. Change from baseline to 6 months in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale. [ Time Frame: Baseline to 6 months ]
    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.

  20. Change from baseline to 1 year in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale. [ Time Frame: Baseline to 1 year ]
    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.

  21. Change from baseline to 2 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale. [ Time Frame: Baseline to 2 years ]
    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.

  22. Change from baseline to 3 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale. [ Time Frame: Baseline to 3 years ]
    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.

  23. Change from baseline to 4 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale. [ Time Frame: Baseline to 4 years ]
    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.

  24. Change from baseline to 5 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale. [ Time Frame: Baseline to 5 years ]
    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.

  25. Incidence of device- and procedure-related serious adverse events at 6 months [ Time Frame: 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.


  26. Incidence of device- and procedure-related serious adverse events at 1 year [ Time Frame: 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.


  27. Incidence of device- and procedure-related serious adverse events at 2 years [ Time Frame: 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.


  28. Incidence of device- and procedure-related serious adverse events at 3 years [ Time Frame: 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.


  29. Incidence of device- and procedure-related serious adverse events at 4 years [ Time Frame: 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.


  30. Incidence of device- and procedure-related serious adverse events at 5 years [ Time Frame: 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  1. Subject is scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system within 180 days.
  2. Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure.

Exclusion Criteria:

  1. Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study.
  2. Subject has anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results.
  3. Study center is located in the United States, and indication for DBS implant is not Parkinson's disease or disabling tremor.
  4. Study center is located in the United States, and the intended lead implant location is not at, or in close proximity to, the STN, GPi, or VIM thalamus.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04071847


Contacts
Layout table for location contacts
Contact: Mike Frassica, PHD +19725269653 michael.frassica@abbott.com
Contact: Bradley White 616 443 2812 bradley.white@abbott.com

Locations
Show Show 48 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
Layout table for investigator information
Study Director: Brad Maruca Abbott Medical Devices Neuromodulation
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT04071847    
Other Study ID Numbers: ABT-CIP-10300
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Dystonia
Dystonic Disorders
Tremor
Essential Tremor
Movement Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Synucleinopathies
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations