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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Procedure: Personalized DBS adjustments

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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reaction time	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'	30-60 minutes after stimulation adjustment
Verbal Fluency	Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation'	30-60 minutes after stimulation adjustment
Finger tapping speed	Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation'	30-60 minutes after stimulation adjustment

Collaborators and Investigators

• Sponsor: Darlene Floden
• Investigators: Principal Investigator: Darlene Floden, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2018
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 11, 2019

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 17-1350

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No