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

NCT05658302 | Recruiting

• 1 other identifier: STUDY00015253
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (4)

• reach-related modulation

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

  2 days

• N-back task trials

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

  2 days

• rigidity and bradykinesia assessments

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

  1 day

• peak frequency of the ERs + spontaneous LFPs

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

  1 day

Secondary Outcomes (3)

• N-back task trials

  2 days

• rigidity/bradykinesia measurements and correlations to conditions

  1 day

• task vs. rest and topographical location

  2 days

Study Arms (1)

Parkinson's disease

* 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 * Existing or planned 7T brain imagery

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PD patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University Of Minnesota

Minneapolis, Minnesota, 55445, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Emily Weatherill

CONTACT

612-625-4947; weath210@umn.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 20, 2022
• Study Start: March 28, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

US (1)