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| ID | Type | Description | Link |
|---|---|---|---|
| R21NS111301 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| The University of Tennessee, Knoxville | OTHER |
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The objective of this study is to further the understanding and application of 60Hz subthalamic deep brain stimulation (STN-DBS) in Parkinson's patients with gait disorder. The investigators will achieve this through 2 study aims:
Gait disorder, which manifests as shuffling, reduction in speed, multistep turning, and/or freezing of gait (FOG), can arise later in the Parkinson's disease (PD) course and cause significant disability. Ultimately, patients are at risk for falls and can become socially isolated due to their mobility limitations. These symptoms tend not to respond to high frequency STN-DBS. However, lower frequency stimulation (60-80Hz) of the STN in treating gait disorder and/or freezing of gait has demonstrated benefit. This study potentially can expand knowledge of 60hz DBS while improving its utilization in combination with PD medications-enabling sustainable and possibly predictable therapeutic benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep Brain Stimulation(DBS) OFF Medication | Experimental | Subthalamic-DBS in the Levodopa OFF state. |
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| Deep Brain Stimulation(DBS) ON Medication | Experimental | Subthalamic-DBS in the Levodopa ON state. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Brain Stimulation | Device | Each DBS electrode contact will be reprogrammed in 60hz and High Frequency Stimulation (180hz) in the Levodopa ON (medicated) and OFF (unmedicated) conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Kinematic Response for 180 and 60Hz DBS | The measurements of interest were captured during the instrumented walk. Interaction of DBS Frequency and Levodopa on gait kinematics was assessed using LM-ANOVA. | 1-2 minute period with each stimulation condition in the Medicated and Unmedicated states. |
| Accuracy of Discriminating STN-DBS (60hz vs. High Frequency) and Medication States With Machine Learning(ML) | We apply ML techniques to a data set of gait kinematics acquired from instrumented walking assessments and utilize random forest ML algorithms to identify participants' stimulation frequency/medication condition. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hand Tremor Severity for 180 and 60Hz DBS | The difference in tremor (e.g. rest, postural) severity will be measured with the kinesia sensor for each DBS electrode stimulation pair (60hz or High Frequency) in both the medicated and unmedicated states on a severity scale from 0-4. Higher number = worse outcome | 1 minute test session for each stimulation condition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ritesh Ramdhani, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwell Health | Great Neck | New York | 11021 | United States |
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All Subjects were recruited through the Movement Disorders Center at Northwell Health, NY.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | 4 Phases: I - OFF DBS/OFF MED II- 180Hz DBS/ON MED III- 60Hz DBS/ON MED IV: OFF DBS/ON MED |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| OFF Med/OFF DBS |
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| 180Hz DBS ( OFF MED) |
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| 180Hz (ON MED) |
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| 60Hz DBS (OFF MED) |
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| 60Hz (ON Med) |
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| ON MED/OFF DBS |
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| ID | Title | Description |
|---|---|---|
| BG000 | Deep Brain Stimulation(DBS) OFF & ON Medication | Subthalamic-DBS in the Levodopa OFF and ON state. Deep Brain Stimulation: Each DBS electrode contact will be reprogrammed in 60hz and High Frequency Stimulation (180hz) in the OFF (unmedicated) and ON (medicated) conditions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Gait Kinematic Response for 180 and 60Hz DBS | The measurements of interest were captured during the instrumented walk. Interaction of DBS Frequency and Levodopa on gait kinematics was assessed using LM-ANOVA. | Scale range 0-100 ( toe angle - higher value is a better outcome; Single limb support - higher value is better outcome; left foot stance % - higher value is worse outcome; left foot swing - higher value is better outcome; left arm range of motion - higher value is better outcome) | Posted | Least Squares Mean | Standard Error | units on a scale | 1-2 minute period with each stimulation condition in the Medicated and Unmedicated states. |
|
Adverse events was assessed during each study visit day. At total of 2-3 study visits over 6 weeks
Adverse Events were monitored for all enrolled subjects during the study period.
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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 | OFF Medication/OFF DBS | Subthalamic-Deep Brain Stimulation OFF / OFF L-Dopa | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ritesh Ramdhani | Feinstein Institute for Medical Research at Northwell | 516-325-7000 | rramdhani@northwell.edu |
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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 | Aug 12, 2021 | Jul 11, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 23, 2021 | Aug 14, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Change in Speed of Limb Movements for 180 and 60Hz DBS | The difference in the speed of limb movements (e.g. hand grasps and leg lifts) will be measured with the kinesia sensor for each DBS electrode stimulation pair (60hz or High Frequency) in both the medicated and unmedicated states on a severity scale of 0-4. Higher values = worse outcome. | 1 minute test session for each stimulation condition |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
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| PD Phenotype | Count of Participants | Participants | No |
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DBS at 180Hz in the On Levodopa state |
| OG002 | 60Hz (OFF Med) | DBS at 60Hz in the OFF Levodopa state |
| OG003 | 60Hz (ON MED) | DBS at 60Hz in the On Levodopa state |
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|
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| Primary | Accuracy of Discriminating STN-DBS (60hz vs. High Frequency) and Medication States With Machine Learning(ML) | We apply ML techniques to a data set of gait kinematics acquired from instrumented walking assessments and utilize random forest ML algorithms to identify participants' stimulation frequency/medication condition. | The random forest classifier's predictive accuracy for discriminating OFF DBS/OFF MED condition from alternative DBS/MED conditions is listed below. | Posted | Number | percentage of random forest accuracy | 2 years |
|
|
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| Secondary | Change in Hand Tremor Severity for 180 and 60Hz DBS | The difference in tremor (e.g. rest, postural) severity will be measured with the kinesia sensor for each DBS electrode stimulation pair (60hz or High Frequency) in both the medicated and unmedicated states on a severity scale from 0-4. Higher number = worse outcome | There was significant difference between rest and postural tremor between 60Hz and 180hz | Posted | Least Squares Mean | Standard Error | score on a scale | 1 minute test session for each stimulation condition |
|
|
|
| Secondary | Change in Speed of Limb Movements for 180 and 60Hz DBS | The difference in the speed of limb movements (e.g. hand grasps and leg lifts) will be measured with the kinesia sensor for each DBS electrode stimulation pair (60hz or High Frequency) in both the medicated and unmedicated states on a severity scale of 0-4. Higher values = worse outcome. | There were no significant difference between groups | Posted | Least Squares Mean | Standard Error | score on a scale | 1 minute test session for each stimulation condition |
|
|
|
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | ON Medication/ OFF DBS | Subthalamic- Deep Brain StimulationOFF/ ON L-dopa | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | 60Hz DBS (OFF Med) | Subthalamic- Deep Brain Stimulation(60hz) and OFF L-Dopa | 0 | 24 | 0 | 24 | 0 | 24 |
| EG003 | 60Hz DBS (ON Med) | Subthalamic- Deep Brain Stimulation(60hz) and ON L-Dopa | 0 | 24 | 0 | 24 | 0 | 24 |
| EG004 | 180Hz (OFF Med) | Subthalamic- Deep Brain Stimulation(180hz) and OFF L-Dopa | 0 | 24 | 0 | 24 | 0 | 24 |
| EG005 | 180Hz (ON Med) | Subthalamic- Deep Brain Stimulation(60hz) and ON L-Dopa | 0 | 24 | 0 | 24 | 0 | 24 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Left Hand Postural Tremor |
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| Right Hand Rest Tremor |
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| Right Hand Postural Tremor |
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| Right Hand Movement Speed |
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