INTREPID (Implantable Neurostimulator for the Treatment of Parkinson's Disease)

Overview

Status: Recruiting
Keywords: Deep Brain Stimulation , Parkinson's Disease
IRB Number: 00055315
Specialty: Neurology, Neurology, Neurology
Sub Specialties: Movement Disorders, Parkinson's Disease, Deep Brain Stimulation

Brief Summary

Primary objective: To evaluate the safety and effectiveness of the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy for improving the number of waking hours per day with good symptom control and no troublesome dyskinesia (ON time) in adults with advanced, levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication.

Secondary objectives: To evaluate the effectiveness of STN-DBS with the Vercise™ system on health outcomes including: general quality of life measures, levodopa equivalent medication use, the severity of PD symptoms and cost-effectiveness in subjects with advanced, levodopa-responsive Parkinson’s disease.

Principal Investigator: Lauren Schrock
Department: Neurology
Co Investigator: David Shprecher

Contact Information

Name:Tyler Hohnholt
Phone: 801-581-7978
Email: tyler.hohnholt@hsc.utah.edu

Inclusion Criteria

Clinical Inclusion Criteria

  1. Age at the time of enrollment: 22 - 75 years.
  2. Diagnosis of bilateral idiopathic PD with the presence of at least 2 of the following: resting tremor, rigidity, or bradykinesia.
  3. Duration of idiopathic PD: ≥ 5 years of motor symptoms.
  4. Severity of bilateral idiopathic PD in the meds off condition: modified Hoehn and Yahr stage ≥ 2.
  5. Greater than or equal to 6 hours of poor motor function (OFF time plus ON time with troublesome dyskinesias) per day as assessed by PD diary.
  6. Persistent disabling Parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy.
  7. Must have tried a form of carbidopa/levodopa and/or one of the dopamine agonists as part of medication therapy.
  8. Anti-parkinsonian medications must improve PD symptoms by ≥ 33%, as measured by UPDRS-III score.
  9. UPDRS-III score of ≥ 30 in the meds off condition.
  10. DRS-2 (Dementia Rating Scale -2) score ≥ 130 in the meds on condition.
  11. BDI-II score < 17 in the meds on condition.
  12. No change in antidepressant medications utilized for treatment of depression for at least 8 weeks prior to informed consent.
  13. Stable on anti-parkinsonian medication for 28 days prior to informed consent.
  14.  An appropriate candidate for the surgical procedures required for bilateral STN DBS.
  15. Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging system and completing the PD Diary).
  16. Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.

 

Exclusion Criteria

Clinical Exclusion Criteria

  1. Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
  2. Have any significant psychiatric condition likely to compromise the subject’s ability to comply with requirements of the study protocol (e.g. bipolar, schizophrenia, mood disorder with psychotic features, cluster B personality disorders)
  3. Have untreated clinically significant depression per DSM-IV (Diagnostics and Statistical Manual of Mental Disorders) criteria as determined by BDI-II score ≥ 17
  4. Any current drug or alcohol abuse, per DSM-IV criteria.
  5. Any history of recurrent or unprovoked seizures.
  6. Any history of hemorrhagic stroke.
  7. Any prior movement disorder treatments that involved intracranial surgery or device implantation.
  8. Any other active implanted devices including neurostimulators (e.g., cochlear implant, pacemaker) and /or drug delivery pumps, whether turned on or off. Passive implants (e.g., knee prostheses) would be allowed provided that they do not interfere with the functioning of the VerciseTM system.
  9. Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure.
  10. Any previously implanted Vagus Nerve Stimulation (VNS) patients.
  11. Any previous brain surgery that would interfere with the placement of the leads or the functioning of the device.
  12. A condition requiring or likely to require the use of Magnetic Resonance Imaging (MRI), diathermy or electroconvulsive therapy (ECT).
  13. Likely to require the use of monopolar cautery, radio-frequency (RF) procedures, external defibrillation, lithotripsy, radiation therapy or transcranial stimulation.
  14. Currently on any anticoagulant medications that cannot be discontinued during perioperative period.
  15. Currently exhibiting secondary Parkinsonism due to prescribed medications.
  16. Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
  17. Any terminal illness with life expectancy of < 1 year.
  18. Any unresolved infection, a coagulopathy or significant cardiac or other medical risk factor for surgery.
  19. Current or future risk of being immunocompromised that might significantly increase risk of infection.
  20. History of suicide attempt or current active suicidal ideation as determined by a positive response to items 2 -5 of suicide ideation sub-scale of the Columbia Suicide Severity Rating Scale (C-SSRS).
  21. Participation in any other clinical trial (e.g. drug, device, or biologics) concurrently or within the preceding 30 days. Participation in any other study will be allowed per investigator/sponsor discretion only.
  22. Plan to receive any procedure that involves sudden jerking motions of the head or neck (e.g. certain chiropractic therapies) or massage and manipulation directly over the leads in the scalp, neck or chest, at any time during the study.
  23. A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.
  24. Any impairment that would limit subject’s ability to record PD Diary entries or perform wound care, unless a caregiver is available to assist. 
  25. More than 4 hours of data missing in a given day from the screening PD Diary.
  26. Not able to speak, write and read in English language as determined by the investigator.