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Stimulation Parameters and Non-motor Symptoms in PD Treated With DBS (FREQUENCY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03800108
Recruitment Status : Active, not recruiting
First Posted : January 11, 2019
Last Update Posted : September 2, 2021
Sponsor:
Information provided by (Responsible Party):
Darlene Floden, The Cleveland Clinic

Study Description
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Brief Summary:
This study evaluates the role of subthalamic nucleus (STN) stimulation location and frequency on a range of cognitive processes in Parkinson's patients who have undergone Deep Brain Stimulation (DBS).

Condition or disease Intervention/treatment Phase
Parkinson Disease Procedure: Personalized DBS adjustments Not Applicable

Detailed Description:
Pre- and post- DBS implantation brain scans will be reviewed by the study team to see if patients' DBS settings can be personalized. If so, study subjects will undergo adjustments to their DBS settings and be asked to perform cognitive tests. Some patients will be asked to come back for a second visit for brain scans.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Stimulation Parameters and Non-motor Symptoms in PD Treated With DBS
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Personalized DBS adjustments
Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs
 Procedure: Personalized DBS adjustments
Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs


Outcome Measures
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Primary Outcome Measures :
  1. Reaction time [ Time Frame: 30-60 minutes after stimulation adjustment ]
    Subjects will complete one or more measures of cognitive processing requiring speeded responses to stimuli. Changes in reaction time will be compared to 'off stimulation'

  2. Verbal Fluency [ Time Frame: 30-60 minutes after stimulation adjustment ]
    Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation'

  3. Finger tapping speed [ Time Frame: 30-60 minutes after stimulation adjustment ]
    Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation'


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Between 40 and 70 years of age,
  2. Ability to provide informed consent,
  3. Clinical diagnosis of idiopathic Parkinson disease (PD) by a movement disorders neurologist,
  4. Disease duration of at least 4 years,
  5. Treated with bilateral STN DBS for at least 3 months prior to study enrollment.

Exclusion Criteria:

  1. History of prior neurosurgical intervention for PD (e.g., DBS, thalamotomy, pallidotomy)
  2. History of other central nervous system disease (excluding migraine),
  3. Presence of active psychiatric symptoms meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Axis-I disorder on formal psychiatric evaluation, with the exception of mild depression (Beck Depression Inventory-2 score below 19),
  4. Cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation,
  5. Current alcohol or substance abuse,
  6. Lack of fluency in English which would invalidate cognitive testing,

  7. Hearing or visual impairment precluding cognitive testing.

    Exclusion criteria for Day 2 procedures:

  8. Inability to safely undergo MRI procedure (i.e., metal objects like prostheses, pacemakers)
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): NCT03800108


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Darlene Floden
Investigators
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Principal Investigator: Darlene Floden, PhD The Cleveland Clinic
More Information
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Responsible Party: Darlene Floden, Staff Neuropsychologist, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03800108    
Other Study ID Numbers: 17-1350
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: August 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: No
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