RightFit
RecruitingNot applicable

Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease

Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease - UNMC/Medtronic Collaborative Acute Feasibility Pilot

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
19 Years to 80 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares new patterns of deep brain stimulation (DBS) with usual patterns for Parkinson’s disease. DBS uses an implanted device to send electrical signals to the brain. The study is for people who already have a Medtronic Percept PC device and tests whether the new patterns improve movement with fewer side effects.

This is an open-label, non-randomized, proof-of-concept comparison of clinical vs. research stimulation patterns in patients with Parkinson's disease (PD) being treated with Deep Brain Stimulation (DBS) through the Medtronic Percept PC DBS device. The investigators hypothesize that stimulation patterns designed to better target excessive synchrony in a patient-tailored manner may result in more efficient and effective therapy with fewer side effects. Medtronic 3rd-generation sensing implantable neural stimulator, Percept PC, is FDA-approved for treating PD. The Percept PC device features BrainSense, the first and only available sensing technology for deep brain stimulation. BrainSense technology allows the device to capture and record brain signals (local field potentials, or LFP) using the brain-implanted DBS lead, while simultaneously delivering therapeutic stimulation. Investigators plan to enroll and complete investigations in 15 study subjects total, who have been previously implanted with the Medtronic Percept PC for the treatment of PD, and who are optimized for clinical stimulation and anti-Parkinsons medication. Investigations will be performed in UNMC Movement Disorders Clinic, UNMC Neurosurgery Lab, and UNO Biomechanics Research Building, Gait Lab. Subjects will receive research stimulation patterns and the effect on PD motor symptoms will be assessed via Unified Parkinsons Disease Rating Scale (UPDRS)-part III and gait measures. Videotaping of patient UPDRS-III testing and gait will be obtained.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have Parkinson’s disease with no known cause and met the usual medical rules for DBS surgery.
  • Already have DBS leads on both sides of a brain area called the subthalamic nucleus (STN), connected to a Medtronic Percept PC device.
  • Have had DBS settings and Parkinson’s medicines adjusted for best results for at least 3 months after surgery.
  • Agree to join the study.
  • Have a strong enough brain signal called a beta peak, measured during surgery and detectable with the device’s BrainSense feature.
  • At least 3 months after surgery, have a movement test score that improves by at least 30% with stimulation compared with stimulation off.

Who can't join

  • Do not currently have a Medtronic Percept implanted stimulator.
  • Do not want to join the study.
  • Need frequent changes or more adjustments to DBS settings.
  • Have major side effects caused by stimulation.
  • Need unusual stimulation settings, with rates above 200 Hz or below 100 Hz. Hz means electrical pulses per second.
  • Have an implanted heart device.
  • Have a Medtronic Percept PC device that shows a replacement-needed alert at the start of the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Patients with idiopathic Parkinson's Disease who were recommended for STN DBS using standard clinical inclusion and exclusion criteria (e.g., presence of coagulopathy, dementia, untreated depression, pre-existing implanted stimulation system, prior intracranial surgery, history of alcohol or drug abuse) * Patients have been previously implanted with bilateral STN DBS and the Medtronic Percept PC implantable neural stimulator. * Patients are optimized for clinical stimulation and medication for at least 3 months post-surgery for the implantation of their DBS system. * Consent to study participation * Presence of a robust beta peak (detectable using the Percept BrainSense Survey feature; ≥ 0.7 µV/rtHz), intra-operatively (assessed via Lead Confirm technology from Alpha Omega) * Good response to stimulation (30% improvement on UPDRS III compared to baseline OFF), at least 3 months post-surgery. Exclusion Criteria: * Not currently implanted with the Medtronic Percept INS * Not willing to participate in the study * Unstable stimulation with need for frequent reprogramming or further adjustment * Significant stimulation-induced side effects * Need for unusual programming parameters such as very high (\> 200 Hz) or low (\< 100) frequencies (due to cycle limitations) * The patient has an implanted cardiac device * The patients Medtronic Percept TM PC indicates elective-replacement-indicated (ERI) at the start of the study

Study sites (1)

NE