New stimulation patterns for treating Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of novel deep brain stimulation (DBS) patterns in patients with Parkinson's disease who have been implanted with the Medtronic Percept PC device. It is an open-label, non-randomized proof-of-concept study that compares clinical stimulation patterns with research-designed patterns aimed at reducing excessive brain synchrony. The goal is to determine if these tailored stimulation patterns can provide more effective therapy with fewer side effects. A total of 15 subjects will be enrolled to assess the potential benefits of this innovative approach.

Why it matters

Who can join: the full rules

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

Where it's running

• Unversity of Nebraska Medical Center
  Omaha, Nebraska, United States Recruiting

Study contacts

• Principal investigator: Aviva Abosch, MD, PhD — University of Nebraska
• Study coordinator: Dulce Maroni, PhD
• Email: dmaroni@unmc.edu
• Phone: 402-215-3053

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.