Safety and Efficacy of Adaptive Deep Brain Stimulation

Exclusion Criteria

• •1. Patients with severe cognitive decline, as resulting from MoCA assessment (MoCA score \< 10);
• •2. Patients with major psychiatric issues or any other condition that, based on the physician opinion, could interfere with the study conduct (e.g. severe depression, psychosis, etc.);
• •3. Patients with any medical conditions potentially interfering with DBS battery replacement surgery (e.g. severe hypertension, active cancer, intake of drugs interfering with the coagulation etc.);
• •4. Need to replace or reposition the leads during the IPG replacement procedure;
• •5. Patients with \> 10 recurrent falls experienced in the 3 months prior to consent;
• •6. Patients that cannot tolerate an interruption of DBS stimulation for at least 30 min;
• •7. Patients taking less than one levodopa dose per day;
• •8. Patients without suitable LFPs recordings or with significant artifacts;
• •9. Pregnant or breastfeeding women.
• •De Novo DBS Patients:
• •1. Patient has contraindications for DBS surgery, including any intracranial abnormality (e.g., generalized atrophy, vascular malformation, hydrocephalus, hematoma, cavernous or venous angioma, tumor or metastases, midline shift, etc.) or metallic implant (e.g., aneurysm clip, cochlear implant, etc.);
• •2. Patient has a history of suicide attempt or current active suicidal ideation as determined by a positive response to Item 2-5 of suicide ideation sub-scale of the Columbia Suicide Severity Rating Scale (C-SSRS);
• •3. Patient has dementia, major depression, seizures, congestive heart failure, uncontrolled diabetes, dialysis, substance use disorders as described in DSM-V, or any other severe medical condition;
• •4. Patient has any medical condition that could interfere with study procedures, confound the assessment of study endpoints, or prevent a proper data collection;
• •5. Patient had confirmation of diagnosis of a terminal illness associated with survival \< 12 months;
• •6. Patient needs repeated MRI scans;
• •7. Patient requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT);
• •8. Patient carries an electrical or electromagnetic implant (e.g., cochlear prosthesis, pacemaker, neurostimulator, etc.);
• •9. Patient has, or plans to obtain, an implanted electrical stimulation medical device and/or an implanted medication pump (e.g., DUOPATM infusion pump) and/or is treated with a portable infusion pump;
• •10. Patient is on anticoagulant therapy which cannot be paused for \> 5 days before IPG implant surgery;
• •11. Patient with a history of cranial surgery including ablation procedure or any other previous neurosurgical procedure for the treatment of PD symptoms on either side of the brain;
• •12. Patient is currently participating in another clinical study (excluding any sub-study of the present study);
• •13. Patient is a female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception;
• •14. Patients without suitable LFPs recordings or with significant artifacts.