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Recruitment Challenges due to the reluctance of patients who have achieved successful outcomes with their DBS and hesitation to change their device settings.
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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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This is a study to evaluate Deep brain stimulation (DBS) burst-type electrical stimulation programming verses standard DBS programming. Burst-type DBS is defined as a novel stimulation protocol in which intermittent bursts of traditional high-frequency rectangular wave stimulation are delivered. Burst type DBS may improve the efficacy and durability of DBS pulse generator.
Five (N = 5) subjects that have bilateral subthalamic nucleus deep brain stimulation (STN-DBS), with Boston Scientific Gevia or Genus technology, implanted for Parkinson's Disease (PD). Subjects should be on stable DBS programming settings and stable medication regimens defined as no DBS programming changes or Parkinson's disease medication changes over the past 2 weeks. The DBS implantation should have been performed by either Dr. Nestor D. Tomycz MD or Dr. Donald M. Whiting MD at Allegheny General Hospital and implantation surgery must have occurred a minimum of 6 months prior to the day of enrollment.
Screening Visit- All interested patients will undergo a screening visit during which their eligibility into the study will be determined. Screening will including the following:
Visit 1- Baseline (less than or equal to 30 days after Screening
Randomization- Subjects will be randomized to determine which DBS setting is initially programmed during visit one. All subjects will be programmed to both settings over the course of the visit, but the order is randomized to ensure appropriate blinding of the UPDRS assessor. Subjects have a 50% chance of being randomized to the "burst" mode, and a 50% chance of being randomized to the "baseline" mode.
Visit Two (6 months +/- 30 Days)
Visit Three (12 months +/- 30 days)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline Programming First, Then Experimental Burst-type Programming | Experimental | In this arm, patients were randomized to initially receive treatment with baseline DBS programming (standard of care) at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then experimental Burst-type programming for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming. |
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| Experimental Burst-type Programming First, Then Baseline Programming | Experimental | In this arm, patients were randomized to initially receive treatment with experimental Burst-type DBS programming at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then baseline programming (standard of care) for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming. Burst-type DBS is defined as a novel stimulation protocol in which intermittent bursts of traditional high-frequency rectangular wave stimulation are delivered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baseline (or standard of care) DBS programming | Device | Baseline (or standard of care) DBS programming. |
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| Measure | Description | Time Frame |
|---|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Scores at Baseline (Visit 1) | This outcome is the Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Score in the "Medication Off" state, after the first treatment (administered for 30 minutes) and after the second treatment (administered for 30 minutes). For example, the first treatment for patients in the arm "Baseline Programming First, Then Experimental Burst-type Programming" was baseline (or standard of care) DBS programming, and the second treatment was experimental Burst-style programming. Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108. A higher score indicates a worse outcome. | Baseline |
| Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Scores at Six Months (Visit 2) | This outcomes is the Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Score in the "Medication Off" state and after burst-type DBS programming in the acute setting (after 30 minutes) at six months. Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108. A higher score means a worse outcome. Note that the study arm titles refer to whether or not the patients were randomized to baseline programming or Burst-type programming at Visit 1. During this visit (Visit 2), all study subjects were to be evaluated in the medication-off state and then evaluated following 30 minutes of treatment with Burst-type programming. Treatment with baseline programming was not administered during this visit (Visit 2). | 6 months |
| Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Scores at Twelve Months (Visit 3) | This outcomes is the Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Score in the "Medication Off" state and after burst-type DBS programming in the acute setting (after 30 minutes) at 12 months. Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108. A higher score means a worse outcome. Note that the study arm titles refer to whether or not the patients were randomized to baseline programming or Burst-type programming at Visit 1. During this visit (Visit 2), all study subjects were to be evaluated in the medication-off state and then evaluated following 30 minutes of treatment with Burst-type programming. Treatment with baseline programming was not administered during this visit (Visit 2). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nestor Tomycz | Allegheny Health Network AGH Department of Neuroscience | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AHN Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
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2 subjects were recruited in the medical clinic between August 24, 2022, and February 21, 2024. Recruitment ended as we encountered significant challenges in recruiting participants for the study finding reluctance of patients who have achieved successful outcomes with their deep brain stimulation (DBS) devices to participate. They are understandably hesitant to risk potential symptom worsening by altering their device settings, even for the purpose of research.
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| ID | Title | Description |
|---|---|---|
| FG000 | Baseline Programming First, Then Experimental Burst-type Programming | In this arm, patients were randomized to initially receive treatment with baseline DBS programming (standard of care) at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then experimental Burst-type programming for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Visit 1: First Treatment (30 Min) |
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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 | Feb 19, 2024 |
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Randomized, double-blind cross-over study
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Subjects will be programmed to both settings over the course of the visits, but the order is randomized to ensure appropriate blinding of the UPDRS assessor.
Unblinded examiner will then turn the DBS ON to the patient's baseline DBS settings continuously ON or to burst DBS mode.
A blinded examiner who did not perform the programming change will perform a UPDRS-III evaluation
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| Burst-type DBS electrical stimulation programming | Device | Burst-type DBS is defined as a novel stimulation protocol in which intermittent bursts of traditional high-frequency rectangular wave stimulation are delivered. |
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| 12 months |
| FG001 | Experimental Burst-type Programming First, Then Baseline Programming | In this arm, patients were randomized to initially receive treatment with experimental Burst-type DBS programming at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then baseline programming (standard of care) for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming. Burst-type DBS is defined as a novel stimulation protocol in which intermittent bursts of traditional high-frequency rectangular wave stimulation are delivered. |
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| NOT COMPLETED |
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| Visit 1: Washout Period (15 Min) |
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| Visit 1: Second Treatment (30 Min) |
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| Visit 2: Burst-type Programming (30 Min) |
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| Visit 3: Burst-type Programming (30 Min) |
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No subjects were enrolled in the standard of care programming arm. 2 were enrolled in the Experimental/Burst type programming arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Programming First, Then Experimental Burst-type Programming | In this arm, patients were randomized to initially receive treatment with baseline DBS programming (standard of care) at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then experimental Burst-type programming for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming. |
| BG001 | Experimental Burst-type Programming First, Then Baseline Programming | In this arm, patients were randomized to initially receive treatment with experimental Burst-type DBS programming at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then baseline programming (standard of care) for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming. Burst-type DBS is defined as a novel stimulation protocol in which intermittent bursts of traditional high-frequency rectangular wave stimulation are delivered. |
| BG002 | Total | Total of all reporting groups |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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 | Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Scores at Baseline (Visit 1) | This outcome is the Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Score in the "Medication Off" state, after the first treatment (administered for 30 minutes) and after the second treatment (administered for 30 minutes). For example, the first treatment for patients in the arm "Baseline Programming First, Then Experimental Burst-type Programming" was baseline (or standard of care) DBS programming, and the second treatment was experimental Burst-style programming. Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108. A higher score indicates a worse outcome. | No subjects were randomized to the arm that received baseline (standard of care) programming first, followed by experimental Burst-style programming (at Visit 1). | Posted | Median | Full Range | score on a scale | Baseline |
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| Primary | Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Scores at Six Months (Visit 2) | This outcomes is the Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Score in the "Medication Off" state and after burst-type DBS programming in the acute setting (after 30 minutes) at six months. Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108. A higher score means a worse outcome. Note that the study arm titles refer to whether or not the patients were randomized to baseline programming or Burst-type programming at Visit 1. During this visit (Visit 2), all study subjects were to be evaluated in the medication-off state and then evaluated following 30 minutes of treatment with Burst-type programming. Treatment with baseline programming was not administered during this visit (Visit 2). | No subjects were randomized to the arm that received baseline (standard of care) programming first, followed by experimental Burst-style programming (at Visit 1). Follow-up data at six months (Visit 2) were only available for one of the two patients randomized to first be treated with the experimental Burst-type programming at Visit 1. Additionally, data were not collected in the Medication Off state for the patient for whom there are follow-up data at six months (Visit 2). | Posted | Median | Full Range | score on a scale | 6 months |
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| Primary | Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Scores at Twelve Months (Visit 3) | This outcomes is the Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Score in the "Medication Off" state and after burst-type DBS programming in the acute setting (after 30 minutes) at 12 months. Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108. A higher score means a worse outcome. Note that the study arm titles refer to whether or not the patients were randomized to baseline programming or Burst-type programming at Visit 1. During this visit (Visit 2), all study subjects were to be evaluated in the medication-off state and then evaluated following 30 minutes of treatment with Burst-type programming. Treatment with baseline programming was not administered during this visit (Visit 2). | No subjects were randomized to the arm that received baseline (standard of care) programming first, followed by experimental Burst-style programming (at Visit 1). Follow-up data at 12 months were only available for one of the two patients randomized to first be treated with the experimental Burst-type programming at Visit 1. Additionally, data were not collected in the Medication Off state for the patient for whom there are follow-up data at six months (Visit 2). | Posted | Median | Full Range | score on a scale | 12 months |
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364 Days
While this study has been entered as a cross-over study, the only cross-over element of the study occurred during Visit 1. Because of this, the short duration of the treatment periods (of 30 minutes) and the washout period (of 15 minutes) during this visit and the possibility of adverse events in between study visits, adverse events were summarized for the entire study duration and not by treatment period on Visit 1. No adverse events occurred.
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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 | Baseline Programming First, Then Experimental Burst-type Programming (at Visit 1) | In this arm, patients were randomized to initially receive treatment with baseline DBS programming (standard of care) at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then experimental Burst-type programming for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Experimental Burst-type Programming First, Then Baseline Programming (at Visit 1) | In this arm, patients were randomized to initially receive treatment with experimental Burst-type DBS programming at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then baseline programming (standard of care) for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming. Burst-type DBS is defined as a novel stimulation protocol in which intermittent bursts of traditional high-frequency rectangular wave stimulation are delivered. | 0 | 2 | 0 | 2 | 0 | 2 |
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This study was terminated due to challenges in recruiting participants as reluctance of patients who have achieved successful outcomes with their DBS devices to participate. They are understandably hesitant to risk potential symptom worsening by altering their device settings, even for the purpose of research. One subject completed the trial and the second subject withdrew due to intolerance of the device settings. Both subjects were enrolled in the experimental arm of the trial.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Megan Hendricks, regulatory Specialist | Allegheny Health Network | 412-330-6206 | megan.hendricks@ahn.org |
| Nov 7, 2024 |
| Prot_SAP_000.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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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG001 | Experimental Burst-type Programming First, Then Baseline Programming (at Visit 1) | In this arm, patients were randomized to initially receive treatment with experimental Burst-type DBS programming at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then baseline programming (standard of care) for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming. Burst-type DBS is defined as a novel stimulation protocol in which intermittent bursts of traditional high-frequency rectangular wave stimulation are delivered. |
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| OG001 | Experimental Burst-type Programming First, Then Baseline Programming (at Visit 1) | In this arm, patients were randomized to initially receive treatment with experimental Burst-type DBS programming at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then baseline programming (standard of care) for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming. Burst-type DBS is defined as a novel stimulation protocol in which intermittent bursts of traditional high-frequency rectangular wave stimulation are delivered. |
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