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NCT Number: NCT05822388

Cognitive Decline Following Deep Brain Stimulation

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Daniel H Lench, PhD

CONTACT

[email protected]

843-792-9115

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical Care

Procedure

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 outcomes

  1. Change in Cognition

    Time frame: From the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation) until 1 year post surgery

    Change in cognitive performance using a comprehensive neuropsychological battery (e.g., language, executive control, memory, and attention)

  2. Brain Microstructure (DKI)

    Time frame: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))

    Nucleus Basalis of Meynert (NBM) and striatal microstructural integrity using diffusion kurtosis imaging (mean kurtosis; MK)

Secondary outcomes

  1. Brain Functional Connectivity

    Time frame: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))

    Functional connectivity in cognitive networks including the Nucleus Basalis of Meynert (NBM) and the striatum

  2. Brain Microstructure (DTI)

    Time frame: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))

    Nucleus Basalis of Meynert (NBM) and striatal microstructural integrity using diffusion tensor imaging (mean diffusivity; MD)

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel H Lench, PhD

CONTACT

[email protected]

843-792-9115

Gonzalo J Revuelta, DO

CONTACT

[email protected]

843-792-7262

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

A Neural Basis for Cognitive Decline Following Deep Brain Stimulation

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 20, 2023
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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