Parkinson Disease
Conditions
Brief summary
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).
Interventions
DEVICEVercise DBS System
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.
Sponsors
Boston Scientific Corporation
Jonathan Jagid
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Inclusion: 1. Confirmed Parkinson's Disease according to movement disorder neurologist with documented exclusion of other disorders such as fronto-temporal dementia (FTD)/ frontal gait disorder/normal pressure hydrocephalus (NPH)/progressive supranuclear palsy (PSP) 2. PD stage3 ON medication, with severe gait dysfunction and predominant axial symptoms: Movement Disorder Society-Unified Parkinson's Disease Rating Scale Tremor Dominant (MDS-UPDRS TD), Postural Instability Gait Difficulty (PIGD) ratio ≤ 0.90 and Freezing Of Gait Questionnaire (FOGQ) score \> 12. 3. Age 40-75 with good response to Levodopa (defined as greater than 20% improvement in UPDRS score) 4. FOG refractory to LEVODOPA\>600 mg 5. 6\. Minimal tremor, bradykinesia, and rigidity symptoms, or well controlled with Levodopa and/or with already implanted STN/GPi DBS. 6. a) Poor candidate for STN or GPi DBS due to good control of tremor, bradykinesia, and rigidity symptoms with Levodopa b) or Post-operative STN/GPi DBS PD patients with significant residual non-levodopa responsive postural and gait instability 7. Must agree to full 6-month participation in study. Exclusion: 1. Individuals with major executive dysfunction 2. Individuals with dementia, as defined by the Mattis Dementia Rating Scale-2 (DRS-2) score ≤ 130 3. Individuals with other neurocognitive impairments 4. Individuals who have depression, as defined for example by the Beck Depression Inventory II (BDI-II) \> 25 5. Presence of major medical co-morbidities and other surgical contra-indications such as coagulopathy 6. Individuals who require diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT) 7. Individuals with a history of prior intracranial surgery 8. Individuals with a metallic implant in their head that is not MRI compatible (e.g., aneurysm clip, cochlear implant) 9. Individuals with active implantable devices anywhere in the body (e.g. cardiac pacemaker, defibrillator, spinal cord stimulator, implanted medication pump) 10. Individuals who are pregnancy or desire to become pregnant during the study 11. Individuals who are breastfeeding12. 12. Individuals who are on investigational drugs and any other intervention (not part of the guidelines for management of Parkinson's Disease) known to have a potential impact on outcome 13. Subjects utilizing recreational drugs at the time of screening will be excluded from the study with the exception of medicinal marijuana
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Gait Velocity | Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op | 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. |
| Percent change in UPDRS Part III on/off stimulation | Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op | Percent change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III on/off stimulation across study visits relative to pre-operative assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in PDQ 39 | Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op | 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. |
| Percent Change in number of Falls | Baseline, 24 weeks | Percent change in number of falls during gait testing sessions and on item 13 of UPDRS III (falls unrelated to freezing) |
| Percent Change in Muscle Amplitude | Baseline, 24 weeks | Percent change in muscle amplitude during gait testing using electromyography (EMG) |
| Percent Change in PDQ-L | Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op | 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. |
| Percent Change in FOG Questionnaire | Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op | 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 . |
Countries
United States
Outcome results
None listed