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NCT Number: NCT03204526

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Parkinson's disease, undergoing deep brain stimulation implantation as part of their routine management of motor symptoms.

Exclusion criteria

Treatment and study plan

Deep brain stimulation

Device

Primary outcomes

  1. Mean Reaction Time for Computerized Color Naming Stroop Task

    Time frame: 2 days

    The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect.

  2. Mean Accuracy Rates Using Computerized Color Naming Stroop Task

    Time frame: 2 days

    The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect.

Secondary outcomes

  1. Number of Participants With Worsening Depression Using Beck's Depression Index

    Time frame: 2 days

    Questionnaire with numerical score indicating level of depression. Individual scale items are scored on a 4-point continuum (0=least, 3=most), with a total summed score range of 0-63. Higher scores indicate greater depressive severity.

  2. Number of Participants Showing Motor Worsening Using the Unified Parkinson's Disease Rating Scale (UPDRS-III)

    Time frame: 2 days

    The UPDRS scale is a rating tool used to gauge the course of Parkinson's disease in patients and consists of the following five segments: 1) Mentation, Behavior, and Mood, 2) ADL, 3) Motor sections, 4) Modified Hoehn and Yahr Scale, and 5) Schwab and England ADL scale.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Safety and Feasibility of Using Low Frequency Deep Brain Stimulation of the Subthalamic Nucleus to Improve Cognitive Performance in Patients With Parkinson's Disease

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2017
Registry last updated
Jun 23, 2021

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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