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Dual Frequency Stimulation in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT04650932
Recruitment Status : Not yet recruiting
First Posted : December 3, 2020
Last Update Posted : December 21, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Study Description
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Brief Summary:
Deep brain stimulation (DBS) in the dorsal region of the subthalamic nucleus (STN) is very effective for reducing motor symptoms of Parkinson's disease (PD). Modeling studies suggest that this therapy may result in current spread into the ventral STN, causing altered cognitive processes. As a result, current stimulation parameters often lead to worsening in verbal fluency, executive function, and, particularly, cognitive control. There is evidence suggesting that low frequency oscillatory activity occurs across brain circuits important in integrating information for cognition. Preclinical studies and human recording studies indicate these low frequency theta oscillations drive cognitive control during cognitive tasks. Thus, the purpose of this study is to determine the safety, tolerability, and efficacy of low frequency stimulation (LFS) of the ventral STN alongside standard high frequency stimulation (HFS) of the dorsal STN in patients with PD.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Deep brain stimulation Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open-label
Primary Purpose: Treatment
Official Title: Dual Frequency, Dual Region Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease
Estimated Study Start Date : March 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sustained Dual Frequency, Dual Region, Stimulation Device: Deep brain stimulation
Patients with idiopathic Parkinson's disease who have previously been implanted with the Boston Scientific VerciseTM DBS system for at least 3 months. These patients will already be receiving high-frequency dorsal STN stimulation as part of the standard of care for PD. Once patients have provided consent and are enrolled in this study, they will receive simultaneous low-frequency stimulation of the ventral STN to examine if there are any effects on cognitive performance.
Other Name: Boston Scientific Vercise DBS


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change from Baseline in Depression Scores on the Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Baseline, Week 2, Week 6, Month 3, and Month 6 ]
    The score of the CES-D will be compared across sessions and a score that rises above 20 (out of 60) will be considered positive for the development of depression.

  2. Mean Change from Baseline in Impulsiveness Scores on the Barratt Impulsiveness Scale (BIS-11) [ Time Frame: Baseline, Week 2, Week 6, Month 3, and Month 6 ]
    The score of the BIS-11 will be evaluated across sessions and elevated scores indicate greater impulsivity and risk-taking behavior. The scale involves 30 questions with values from 1-4. Overall scores range from 30-120.

  3. Mean Change from Baseline in Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, Week 2, Week 6, Month 3, and Month 6 ]
    The NPI assesses frequency, change in severity, and distress over 12 neuropsychiatric domains as evaluated by the caregiver. We will look for a significant score reduction in any domain of the NPI.

  4. Mean Change from Baseline in Movement Scores on Part III of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: Baseline, Week 2, Week 6, Month 3, and Month 6 ]
    Part III of the MDS-UPDRS consists of 18 areas of motor assessments to assess severity of symptoms. Each score is rated in terms of severity from 0-4, with higher scores indicating higher severity of symptoms. A composite score will be evaluated for changes from baseline.

  5. Mean Change from Baseline in Cognitive Performance Scores on the Montreal Cognitive Assessment - Blind (MoCA) [ Time Frame: Baseline, Hour 24, Week 1, Month 1, Month 2, Month 4, and Month 5 ]
    This will be collected via telephone calls. The MoCA-Blind has been validated for telephone administration. We will re-evaluate MoCA-Blind scores during telephone monitoring to assess any changes to cognitive ability. A total score of less than 15 out of a possible 22 indicates greater than mild cognitive impairment.

  6. Mean Change from Baseline in Depression Scores on the CES-D Short Version (CES-D-R10) [ Time Frame: Baseline, Hour 24, Week 1, Month 1, Month 2, Month 4, and Month 5 ]
    This will be collected via telephone calls. Patients will be given an unmarked form with questions and will be able to follow along the telephone conversation and answer each question (0-4 severity rating scale) for 10 questions focused on patient affect. A total score greater than 10 (out of 30) indicates the development of depression symptoms.

  7. Mean Change from Baseline in Motor and Non-Motor Aspects of Daily Living Scores on Parts I and II of the MDS-UPDRS [ Time Frame: Baseline, Hour 24, Week 1, Month 1, Month 2, Month 4, and Month 5 ]
    This will be collected via telephone calls. Patients will be asked questions relating to motor and non-motor aspects of daily living and to rate the severity of their symptoms on a scale from 0-4, with higher scores indicating higher severity of symptoms. We will assess for changes in the composite score from baseline.


Secondary Outcome Measures :
  1. Mean Change from Baseline in Decision-Making Scores on Probabilistic Gambling Task [ Time Frame: Baseline, Minute 30, Week 2, Week 6, Month 3, and Month 6 ]
    A patient-specific measure of risk attitude during a gambling task. We will estimate indifference points (win probability at which risky choice is chosen 50% of the time) at each time point and compare to those points during baseline performance on the task.

  2. Mean Change from Baseline in Inter-Temporal Choice Scores on a Temporal Discounting Task [ Time Frame: Baseline, Minute 30, Week 2, Week 6, Month 3, and Month 6 ]
    A patient-specific measure of risk attitude during a temporal preferences task. We will examine the area under the curve of the empirical discount functions of 'larger later' rewards and 'smaller sooner' rewards. Smaller values indicate increased preference for smaller sooner over larger later rewards. Scores will be compared to baseline performance on the task.

  3. Mean Change from Baseline in Verbal Fluency Scores on Word Generation Task [ Time Frame: Baseline, Minute 30, Week 2, Week 6, Month 3, and Month 6 ]
    The average number of words generated in a 1-minute time frame.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals who are 18 years and older
  • Individuals with idiopathic Parkinson's Disease who previously underwent implantation with the Boston Scientific VerciseTM DBS system
  • Individuals who have been implanted with the Boston Scientific VerciseTM DBS system for at least 3 months
  • Individuals diagnosed with advanced PD who had bilateral dorsal subthalamic nucleus DBS surgery, as standard of care for motor improvement, with distal contacts of the electrodes implanted into the ventral STN

Exclusion Criteria:

  • Individuals unable to provide consent and/or lack capacity to consent
  • Individuals diagnosed with any cognitive or physical impairments that would limit their ability to participate in the cognitive testing
  • Individuals who score below 15 on the Montreal Cognitive Assessment Test-Blind
  • Individuals who score above 20 on the Center for Epidemiologic Studies Depression Scale
  • Pregnant women (note: pregnant women are not candidates for DBS surgery), and prisoners
  • Non-English speaking individuals. Cognitive tasks will only be conducted in English.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04650932


Contacts
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Contact: Kiarash Shahlaie, MD, PhD 916-703-5505 krshahlaie@ucdavis.edu
Contact: Ali Izadi, PhD 916-703-5505 aizadi@ucdavis.edu

Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Kiarash Shahlaie, MD, PhD University of California, Davis
More Information
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Publications of Results:

Other Publications:

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04650932    
Other Study ID Numbers: 1633883
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: December 21, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of California, Davis:
DBS
Deep Brain Stimulation
STN
Subthalamic Nucleus
 Parkinson disease
Dual frequency
Dual region
DFDR
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases