Circuit-Based Deep Brain Stimulation for Parkinson's Disease; Udall Project 1 Aim 2 and 3

Parkinson Disease Clinical Trial

Official title:

Circuit-Based Deep Brain Stimulation for Parkinson's Disease; Udall Project 1 Aim 2 and 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03079037
• Other study ID #: NEUR-2016-22287
• Status: Completed
• Start date: June 19, 2018
• Est. completion date: January 29, 2023

Study information

• Verified date: April 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will test the hypothesis that deep brain stimulation (DBS) targeting specific changes in oscillatory activity at the site of stimulation will prove superior to continuous isochronal DBS thus providing the rationale for development and optimization of closed loop paradigms and determine whether the optimal closed-loop biomarker varies across subcortical targets, is task dependent, or serves to re-establish a default network that removes an underlying disruptive physiological state leading to greater improvement in motor signs and task performance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 29, 2023
• Est. primary completion date: January 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 85 Years

Eligibility

Inclusion Criteria:

• Diagnosis of idiopathic PD

• DBS surgery or IPG battery replacement at UMN is planned as part of routine clinical care.

Exclusion Criteria:

• Other significant neurological disorder

• History of dementia

• Prior history of stereotactic neurosurgery

• 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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Stimulation
Traditional deep brain stimulation

Locations

Country	Name	City	State
United States	University of Minnesota Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure local field potential (LFP) changes in subthalamic nucleus (STN) and globus pallidus (GP) in OFF and ON states of stimulation and medication	Clinical ratings scales (MDS-UPDRS)	2 days