Low Frequency Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease

NCT ID: NCT03204526

Last Updated: 2021-06-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2019-11-30

Brief Summary

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Prospective trial of low frequency deep brain stimulation of the ventral subthalamic nucleus to improve cognitive performance in patients with advanced Parkinson's disease. All study participants have undergone DBS implantation surgery as part of their routine care for motor manifestations of Parkinson's disease. In this study, a temporary low frequency period of stimulation will be applied to determine its effects on cognition.

Detailed Description

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In this randomized cross-over pilot study, our primary aim was to determine the effect of theta (5 Hz), and gamma (130 Hz) frequency stimulation in the ventral STN on cognitive control in patients with PD. This study provides a first look at frequency dependent modulation of cognitive function and provides important insights into the utility of DBS for non-motor symptoms of PD and other neuropsychiatric disorders.

Conditions

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Parkinson Disease Cognitive Impairment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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low frequency stimulation (LFS)

Low-frequency deep brain stimulation of the subthalamic nucleus

Group Type EXPERIMENTAL

deep brain stimulation

Intervention Type DEVICE

Interventions

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deep brain stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Parkinson's disease, undergoing deep brain stimulation implantation as part of their routine management of motor symptoms.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California, Davis

Sacramento, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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693382

Identifier Type: -

Identifier Source: org_study_id

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