Clinical trial NCT05822388: Cognitive Decline Following Deep Brain Stimulation
Official title: A Neural Basis for Cognitive Decline Following Deep Brain Stimulation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Movement Disorders
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease (PD) participants who will undergo DBS surgery and healthy controls.

Brief 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.

Detailed 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Change in Cognition
timeFrame: From the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation) until 1 year post surgery
measure: Brain Microstructure (DKI)
timeFrame: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))
Secondary outcomes:
measure: Brain Functional Connectivity
timeFrame: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))
measure: Brain Microstructure (DTI)
timeFrame: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Daniel H Lench, PhD
role: PRINCIPAL_INVESTIGATOR
References: