Cognitive Decline Following Deep Brain Stimulation

Parkinson Disease Clinical Trial

Official title:

A Neural Basis for Cognitive Decline Following Deep Brain Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05822388
• Other study ID #: Pro00125181
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2024
• Source: Medical University of South Carolina
• Contact: Daniel H Lench, PhD
• Phone: 843-792-9115
• Email: lenchd[@]musc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This research study aims to identify MRI-based brain biomarkers that predict an individual's response to Deep Brain Stimulation (DBS). In particular, this study will focus on changes in cognition associated with DBS. A total of 55 participants with Parkinson's Disease planning to undergo DBS will be recruited from MUSCs Clinical DBS Program. Participants will undergo four visits, including a 1-hour screening visit, a 1.5-hour pre-DBS MRI scanning visit, and a 3.5-hour post-DBS cognitive assessment visit. In addition control participants without Parkinson's Disease will be recruited to undergo MRI scanning and cognitive assessments.

Description:

Deep brain stimulation (DBS) targeting the subthalamic nucleus (STN) is a well-established surgical intervention to treat Parkinson's Disease (PD) patients with disabling motor fluctuations and dyskinesias. Although this therapy is effective for motor complications, a subset of patients will go on to experience cognitive decline, which can overshadow improvements in the quality of life provided by STN-DBS. This accelerated decline in cognition occurs in patients despite rigorous evaluation of their neuropsychological status prior to surgery. While the factors contributing to cognitive decline following DBS remain unclear, there is evidence this may be the result of 1) limited cognitive reserve prior to DBS surgery, 2) stimulation that interferes with cognitive networks, and/or 3) a microlesion effect due to placement of the lead. Understanding how these factors contribute to DBS-induced cognitive decline has the potential to improve patient selection for surgery and optimize the selection of stimulation targets that minimize undesirable cognitive side effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

PD Participants

Inclusion Criteria:

• Subjects above 18 years of age

• Subjects who will undergo DBS surgery as part of their clinical care for PD

Exclusion Criteria:

• Uncorrected visual or hearing impairments, as indicated by self-report

• Individuals who are pregnant or expect to become pregnant during the course of the study

• Individuals with claustrophobia, or the inability to lie supine position in the MRI scanner

• COPD with oxygen dependence

• Non-MRI compatible metal implants (surgical clips or staples, cardiac pacemakers etc.)

Non-PD Control Participants

Inclusion Criteria:

• Subjects above 18 years of age

• Age matched to participants in PD group

Exclusion Criteria:

• Diagnosis of Parkinsons Disease or other movement disorder

• Untreated neuropsychiatric disorders

• Uncorrected visual or hearing impairments, as indicated by self-report

• Individuals who are pregnant or expect to become pregnant during the course of the study

• Individuals with claustrophobia, or the inability to lie supine position in the MRI scanner

• COPD with oxygen dependence

• Non-MRI compatible metal implants (surgical clips or staples, cardiac pacemakers etc.)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Movement Disorders
• Parkinson Disease

Intervention

Procedure:
• Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical Care
Participants in this study will already be undergoing a DBS intervention, however, this is part of their standard clinical care. Pre-surgical DBS candidates that enroll in this study will consent to participate in 1) pre-operative neuroimaging including a high-resolution MRI scan, 2) collection of pre-operative neurocognitive data via chart review and 3) a 1-year postoperative neurocognitive assessment.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cognition	Change in cognitive performance using a comprehensive neuropsychological battery (e.g., language, executive control, memory, and attention)	From the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation) until 1 year post surgery
Primary	Brain Microstructure (DKI)	Nucleus Basalis of Meynert (NBM) and striatal microstructural integrity using diffusion kurtosis imaging (mean kurtosis; MK)	Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))
Secondary	Brain Functional Connectivity	Functional connectivity in cognitive networks including the Nucleus Basalis of Meynert (NBM) and the striatum	Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))
Secondary	Brain Microstructure (DTI)	Nucleus Basalis of Meynert (NBM) and striatal microstructural integrity using diffusion tensor imaging (mean diffusivity; MD)	Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))