LFP Sensing From Directional Leads in the Acute Clinical Setting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deep brain stimulation.
- Who it may be relevant to
- Registry conditions: Parkinson Disease, Idiopathic, Parkinson Disease. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
LFP Sensing From Directional Leads and Associated Clinical Outcomes in the Acute Clinical Setting
Overview
This study plans to learn more about the optimal way to program the Medtronic Deep Brain Stimulation system in patients with Parkinson's Disease.
Detailed description
The investigators will conduct a prospective study in patients with Parkinson's disease (PD) implanted with standard of care, subthalamic nucleus (STN) deep brain stimulation (DBS) electrodes, to test whether monopolar sensing of the maximal power in the beta frequency range (in STN) predicts the optimal therapeutic stimulation setting for alleviation of PD motor symptoms. Participants in this study will have been implanted with a Medtronic DBS system consisting of a PerceptTM PC neurostimulator (battery) and SenSight™ DBS leads (implanted electrodes) with BrainSenseTM technology. The DBS surgery is a standard of care procedure, and no alteration of the surgical plan will occur for research purposes . The ranked response between the clinical profile (therapeutic benefit and adverse effects) and beta power will be compared for all electrical contacts on the implanted electrode. Additional analysis of monopolar sensing compared to differential bipolar sensing, location/distance and volume of neural activation (VNA) of optimal contacts identified by beta power or therapeutic window will be estimated with respect to the STN.
Aim 1- Determine whether monopolar sensing of beta power, in the outpatient clinic setting, will predict the optimal therapeutic contact for electrical stimulation of the STN.
Aim 2 - Long Term Follow Up (\>12 months) of the same consented study participants to determine the stability of the beta power to determine the optimal contact for therapeutic stimulation.
Interventions
- Device Deep brain stimulation
Deep Brain Stimulation programming
Primary outcome measures
- To compare beta frequency power to the TW of each contact. [Time frame: 2 study visits of 4 hours each, one week apart.]
Eligibility criteria
Inclusion Criteria: Parkinson's Disease, scheduled to undergo bilateral subthalamic nucleus (STN) Deep Brain Stimulation (DBS) surgery at the University of Colorado Hospital, chosen to have a Medtronic Deep Brain Stimulation system implanted (Percept™ battery \& SenSight™ electrode). Parkinson's Disease causes upper extremity bradykinesia (slowness of movement) with a MDS-UPDRS1score of 2 or higher when you are off your PD medications.
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Exclusion Criteria: Dementia or other psychological disorders that precludes consent to participate. Inability to follow testing procedures as determined by the study doctor. Inability to be OFF medication for study visits. Existing implanted Deep Brain Stimulation system or implanted cardiac device. Unilateral Medtronic DBS system, or programming not occurring at the University of Colorado Hospital.
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Colorado — Aurora
Identifiers
NCT: NCT06872203 · 21-4938