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Recruiting NCT05822388

Cognitive Decline Following Deep Brain Stimulation

— Observational Parkinson Disease Movement Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical Care.
Who it may be relevant to
Registry conditions: Parkinson Disease, Movement Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Neural Basis for Cognitive Decline Following Deep Brain Stimulation

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change in Cognition [Time frame: From the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation) until 1 year post surgery]
  • Brain Microstructure (DKI) [Time frame: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))]
Secondary outcome measures (2)
  • Brain Functional Connectivity [Time frame: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))]
  • Brain Microstructure (DTI) [Time frame: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))]

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Medical University of South Carolina — Charleston

Identifiers

NCT: NCT05822388 · Pro00125181

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗