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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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The purpose of this research study is to determine if DBS is a safe and effective therapy for severe freezing of gait in patients with Parkinson's Disease. Freezing of gait (FOG) is a particularly debilitating motor deficit seen in a subset of patients with Parkinson's Disease (PD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vercise DBS Group | Experimental | All participants will have the Vercise DBS system implanted. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vercise DBS System | Device | Vercise Deep Brain Stimulation (DBS) System that consists of two bilateral directional DBS Cartesia electrodes implanted in the cuneiform nucleus and a Gevia generator implanted in the upper chest area just below the clavicle. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Gait Velocity | Percent change in gait velocity with and without bilateral cuneiform nucleus deep brain stimulation. Over a distance of 3 meters, gait velocity will be measured using the timed Up and Go test instrumented with Mobility Lab accelerometers. | Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op |
| Percent change in UPDRS Part III on/off stimulation | Percent change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III on/off stimulation across study visits relative to pre-operative assessment | Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in FOG Questionnaire | Freezing of Gait (FOG) Questionnaire is a 6-item questionnaire with each item scored from 0-4. The total score ranges from 0-24 with the higher score indicating more severe freezing of gait . | Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op |
| Percent Change in PDQ 39 |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan R Jagid, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34168545 | Derived | Chang SJ, Cajigas I, Guest JD, Noga BR, Widerstrom-Noga E, Haq I, Fisher L, Luca CC, Jagid JR. MR Tractography-Based Targeting and Physiological Identification of the Cuneiform Nucleus for Directional DBS in a Parkinson's Disease Patient With Levodopa-Resistant Freezing of Gait. Front Hum Neurosci. 2021 Jun 8;15:676755. doi: 10.3389/fnhum.2021.676755. eCollection 2021. | |
| 34078477 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 13, 2025 | Sep 4, 2025 | 11 |
| 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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Parkinson's Disease Questionnaire (PDQ-39) is 39-item questionnaire with a total score ranging from 0-156 with the higher score indicating poorer quality of life. |
| Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op |
| Percent Change in PDQ-L | Parkinson's Disease Quality of Life Questionnaire is a 37-item questionnaire with a total score ranging from 0-185 with the higher score indicating poorer quality of life. | Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op |
| Percent Change in Muscle Amplitude | Percent change in muscle amplitude during gait testing using electromyography (EMG) | Baseline, 24 weeks |
| Percent Change in number of Falls | Percent change in number of falls during gait testing sessions and on item 13 of UPDRS III (falls unrelated to freezing) | Baseline, 24 weeks |
| Derived |
| Chang SJ, Cajigas I, Guest JD, Noga BR, Widerstrom-Noga E, Haq I, Fisher L, Luca CC, Jagid JR. Deep brain stimulation of the Cuneiform nucleus for levodopa-resistant freezing of gait in Parkinson's disease: study protocol for a prospective, pilot trial. Pilot Feasibility Stud. 2021 Jun 2;7(1):117. doi: 10.1186/s40814-021-00855-7. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |