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

NCT ID: NCT03800108

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-30
• Study Completion Date: 2020-01-14

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).

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Personalized DBS adjustments

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

Group Type: OTHER

Personalized DBS adjustments

Intervention Type: PROCEDURE

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

Interventions

Personalized DBS adjustments

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

Intervention Type: PROCEDURE

Eligibility 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.

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Darlene Floden

OTHER

Sponsor Role: lead

Responsible Party

Darlene Floden

Staff Neuropsychologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Darlene Floden, PhD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-1350

Identifier Type: -

Identifier Source: org_study_id