Deep Brain Stimulation of the Cuneiform Nucleus for Levodopa-resistant Freezing of Gait in Parkinson's Disease

A regiszterben nem jelölt feltételek

• Inclusion:
• 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)
• 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.
• Age 40-75 with good response to Levodopa (defined as greater than 20% improvement in UPDRS score)
• FOG refractory to LEVODOPA>600 mg
• 6. Minimal tremor, bradykinesia, and rigidity symptoms, or well controlled with Levodopa and/or with already implanted STN/GPi DBS.
• 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
• Must agree to full 6-month participation in study.
  • Exclusion:
• Individuals with major executive dysfunction
• Individuals with dementia, as defined by the Mattis Dementia Rating Scale-2 (DRS-2) score ≤ 130
• Individuals with other neurocognitive impairments
• Individuals who have depression, as defined for example by the Beck Depression Inventory II (BDI-II) > 25
• Presence of major medical co-morbidities and other surgical contra-indications such as coagulopathy
• Individuals who require diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)
• Individuals with a history of prior intracranial surgery
• Individuals with a metallic implant in their head that is not MRI compatible (e.g., aneurysm clip, cochlear implant)
• Individuals with active implantable devices anywhere in the body (e.g. cardiac pacemaker, defibrillator, spinal cord stimulator, implanted medication pump)
• Individuals who are pregnancy or desire to become pregnant during the study
• Individuals who are breastfeeding12.
• 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
• Subjects utilizing recreational drugs at the time of screening will be excluded from the study with the exception of medicinal marijuana