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Dual Frequency Stimulation in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Deep brain stimulation

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring DBS, Deep Brain Stimulation, STN, Subthalamic Nucleus, Parkinson disease, Dual frequency, Dual region, DFDR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

UC Davis HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sustained Dual Frequency, Dual Region, Stimulation

Arm Description

Outcomes

Primary Outcome Measures

Mean Change from Baseline in Depression Scores on the Center for Epidemiologic Studies Depression Scale (CES-D)

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.

Mean Change from Baseline in Impulsiveness Scores on the Barratt Impulsiveness Scale (BIS-11)

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.

Mean Change from Baseline in Neuropsychiatric Inventory (NPI)

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.

Mean Change from Baseline in Movement Scores on Part III of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

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.

Mean Change from Baseline in Cognitive Performance Scores on the Montreal Cognitive Assessment - Blind (MoCA)

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.

Mean Change from Baseline in Depression Scores on the CES-D Short Version (CES-D-R10)

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.

Mean Change from Baseline in Motor and Non-Motor Aspects of Daily Living Scores on Parts I and II of the MDS-UPDRS

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

Mean Change from Baseline in Decision-Making Scores on Probabilistic Gambling Task

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.

Mean Change from Baseline in Inter-Temporal Choice Scores on a Temporal Discounting Task

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.

Mean Change from Baseline in Verbal Fluency Scores on Word Generation Task

The average number of words generated in a 1-minute time frame.

Full Information

NCT ID

NCT04650932

First Posted

November 16, 2020

Last Updated

December 21, 2022

Sponsor

University of California, Davis

1. Study Identification

Unique Protocol Identification Number

NCT04650932

Brief Title

Dual Frequency Stimulation in Parkinson's Disease

Official Title

Dual Frequency, Dual Region Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 22, 2022 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

DBS, Deep Brain Stimulation, STN, Subthalamic Nucleus, Parkinson disease, Dual frequency, Dual region, DFDR

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

Open-label

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sustained Dual Frequency, Dual Region, Stimulation

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Deep brain stimulation

Other Intervention Name(s)

Boston Scientific Vercise DBS

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mean Change from Baseline in Depression Scores on the Center for Epidemiologic Studies Depression Scale (CES-D)

Description

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.

Time Frame

Baseline, Week 2, Week 6, Month 3, and Month 6

Title

Mean Change from Baseline in Impulsiveness Scores on the Barratt Impulsiveness Scale (BIS-11)

Description

Time Frame

Baseline, Week 2, Week 6, Month 3, and Month 6

Title

Mean Change from Baseline in Neuropsychiatric Inventory (NPI)

Description

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.

Time Frame

Baseline, Week 2, Week 6, Month 3, and Month 6

Title

Mean Change from Baseline in Movement Scores on Part III of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

Description

Time Frame

Baseline, Week 2, Week 6, Month 3, and Month 6

Title

Mean Change from Baseline in Cognitive Performance Scores on the Montreal Cognitive Assessment - Blind (MoCA)

Description

Time Frame

Baseline, Hour 24, Week 1, Month 1, Month 2, Month 4, and Month 5

Title

Mean Change from Baseline in Depression Scores on the CES-D Short Version (CES-D-R10)

Description

Time Frame

Baseline, Hour 24, Week 1, Month 1, Month 2, Month 4, and Month 5

Title

Mean Change from Baseline in Motor and Non-Motor Aspects of Daily Living Scores on Parts I and II of the MDS-UPDRS

Description

Time Frame

Baseline, Hour 24, Week 1, Month 1, Month 2, Month 4, and Month 5

Secondary Outcome Measure Information:

Title

Mean Change from Baseline in Decision-Making Scores on Probabilistic Gambling Task

Description

Time Frame

Baseline, Minute 30, Week 2, Week 6, Month 3, and Month 6

Title

Mean Change from Baseline in Inter-Temporal Choice Scores on a Temporal Discounting Task

Description

Time Frame

Baseline, Minute 30, Week 2, Week 6, Month 3, and Month 6

Title

Mean Change from Baseline in Verbal Fluency Scores on Word Generation Task

Description

The average number of words generated in a 1-minute time frame.

Time Frame

Baseline, Minute 30, Week 2, Week 6, Month 3, and Month 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kiarash Shahlaie, MD, PhD

Phone

916-703-5505

krshahlaie@ucdavis.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Janice Wang-Polagruto, PhD, CCRP

Phone

916-551-3244

jfwang@ucdavis.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kiarash Shahlaie, MD, PhD

Organizational Affiliation

University of California, Davis

Official's Role

Principal Investigator

Facility Information:

Facility Name

UC Davis Health

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jessica Beatty, MS

Phone

916-734-0901

jabeatty@ucdavis.edu

First Name & Middle Initial & Last Name & Degree

Janice Wang-Polagruto, PhD, CCRP

Phone

916-551-3244

jfwang@ucdavis.edu

12. IPD Sharing Statement

Plan to Share IPD

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Dual Frequency Stimulation in Parkinson's Disease

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