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NCT Number: NCT05658302

Circuit-Based Deep Brain Stimulation for Parkinson's Disease P1A2&3 Catalyst

This study will help us better understand how the brain works in people with Parkinson's disease (PD). PD is a brain disease that gets worse over time, and affects over 10 million people world-wide. A common treatment for PD is Deep Brain Stimulation (DBS). To improve DBS therapy for PD, we need a deeper understanding of how the different parts of the brain work together in PD, and how this relates to movement and thinking problems that people with PD experience.

We may be able to use the results of this study to improve DBS treatments in the future.

Recruiting

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Of Minnesota

Minneapolis, Minnesota, 55445, United States

Location status: Recruiting

Location contact

Michael Park, MD, PhD

CONTACT

About this study

Parkinson's disease (PD) is a progressive neurodegenerative disease affecting over 10 million people world-wide. It can be a debilitating disorder and although studied for decades, the physiological changes in the basal ganglia thalamocortical (BGTC) circuit that underlie its development remain under debate. Deep brain stimulation (DBS) of the subthalamic nucleus (STN) and internal globus pallidus (GPi) has been a highly effective therapy for many patients with PD, however, the results have been highly variable and may be associated with cognitive compromise in some patients. To advance DBS therapies for PD we require a deeper understanding of the local and network-wide circuit dynamics and their relationship to motor signs and cognitive function. This understanding will provide the rationale for optimizing STN and GPi DBS, targeting specific regions within the STN and GPi, and development of patient-specific DBS based on the patients' motor signs and cognitive profile

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of idiopathic PD
  • Surgery at UMN to implant DBS system with directional lead(s) and multiple independent current control IPG is planned as part of routine clinical care
  • At least 21 years old

Exclusion criteria

  • Other significant neurological disorder
  • History of dementia
  • Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
  • Pregnant women
  • Known radiation exposure within the last year that is determined to be unsafe when compounded with the expected radiation dose from intraoperative fluoroscopy to place ECoG strip

Treatment and study plan

Primary outcomes

  1. reach-related modulation

    Time frame: 2 days

    reach-related modulation in beta/HFO power in DBS lead LFPs across OFF, DBS, L-dopa, and DBS+L-dopa conditions.

  2. N-back task trials

    Time frame: 2 days

    directed connectivity between STN and DLPFC compared between the N-back task trials with and without stimulation.

  3. rigidity and bradykinesia assessments

    Time frame: 1 day

    differences in rigidity and bradykinesia assessments between conditions: off-stimulation vs eiDBS-suppression, off-stimulation vs eiDBS-amplification, eiDBS-suppression vs eiDBS-amplification.

  4. peak frequency of the ERs + spontaneous LFPs

    Time frame: 1 day

    the correlation between the peak frequency of the ERs in the GPi (or STN) and that of spontaneous LFPs in the GPi (or STN).

Secondary outcomes

  1. N-back task trials

    Time frame: 2 days

    difference in directed connectivity between the correct reject N-back COGED trials across OFF, DBS, L-dopa, and DBS+L-dopa conditions, as well as measures of directed connectivity between STN/GPi and other ECoG sites (SC/MC/PMC/DLPFC) correlated to the N-back task trials correct response performance across the conditions mentioned above.

  2. rigidity/bradykinesia measurements and correlations to conditions

    Time frame: 1 day

    correlations between each of the rigidity/bradykinesia measurements and the following: 1) amplitude of beta band oscillations in the STN or GPi and 2) information flow between the GPi (or STN) and cortical regions, and 3) PAC. Other secondary outcomes on Day 3 include 1) the coherence between ERs in the GPi or STN and ERs observed in the MC, PMC, and DLPFC; and 2) the correlation of pathway-activation measures (AFtotal) with the amplitude of ERs in the GPi (or STN) across both stimulation settings and patients.

  3. task vs. rest and topographical location

    Time frame: 2 days

    task vs. rest, and topographical location, within each of the conditions.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Weatherill

CONTACT

[email protected]

612-625-4947

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Dec 20, 2022
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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