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

NCT03800108 | Terminated Results

• 1 other identifier: 17-1350
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Personalized DBS adjustments

OTHER

Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs

Procedure: Personalized DBS adjustments

Interventions

Personalized DBS adjustments PROCEDURE

Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs

Personalized DBS adjustments

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of prior neurosurgical intervention for PD (e.g., DBS, thalamotomy, pallidotomy)
• History of other central nervous system disease (excluding migraine),
• 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),
• Cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation,
• Current alcohol or substance abuse,
• Lack of fluency in English which would invalidate cognitive testing,
• Hearing or visual impairment precluding cognitive testing.
• Inability to safely undergo MRI procedure (i.e., metal objects like prostheses, pacemakers)

Sponsors & Collaborators

• Darlene Floden: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Limitations and Caveats

Limitations of this trial include early termination due to a lack of eligible patients which led to a reduced sample size and limited data collection. This constraint impacted the statistical power and the ability to conduct complete analyses as initially planned. Additionally, technical limitations related to EEG data collection and analysis emerged, as key personnel responsible for EEG recording and data processing were unavailable.

Results Point of Contact

• Title: Dr. Darlene Floden
• Organization: Cleveland Clinic

flodend@ccf.org

216-444-1298

Study Officials

• Darlene Floden, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Neuropsychologist

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: January 11, 2019
• Study Start: May 30, 2018
• Primary Completion: January 14, 2020
• Study Completion: January 14, 2020
• Last Updated: February 5, 2025
• Results First Posted: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)