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Cognitive Decline Following Deep Brain Stimulation: A DBS-fMRI Study

A Neural Basis for Cognitive Decline Following Deep Brain Stimulation: A DBS-fMRI Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will attend two post-DBS visits: a 3-hour visit for consent, demographic, and cognitive assessments, and a 3-hour DBS-MRI visit to evaluate brain network connectivity with stimulation ON and OFF."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how deep brain stimulation (DBS) may affect thinking and memory in people with Parkinson’s disease. DBS uses an implanted device to send electrical signals to the brain. People who have had DBS surgery will have thinking tests and MRI brain scans with stimulation turned on and off.

The objective of this research study is to understand how Deep Brain Stimulation (DBS) targeting the subthalamic nucleus (STN) affects cognitive networks in the brain, potentially leading to cognitive decline in patients with Parkinson's Disease (PD). A total of 55 participants with PD who have undergone DBS surgery will be recruited from MUSC's Clinical DBS Program. Participants will attend two post-DBS visits: a 3-hour visit for consent, demographic, and cognitive assessments, and a 3-hour DBS-MRI visit to evaluate brain network connectivity with stimulation ON and OFF. These findings will help improve patient selection for surgery and optimize the selection of stimulation targets that minimize undesirable cognitive side effects.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are older than 18.
  • You have Parkinson’s disease diagnosed using UK Brain Bank rules.
  • You had exams of your brain, nerves, and thinking skills at MUSC’s movement disorder center.
  • You were selected for DBS implants on one or both sides of a brain area called the subthalamic nucleus (STN). The implants must be safe for a 3T MRI scanner.

Who can't join

  • You report vision or hearing problems that have not been corrected.
  • You are pregnant or expect to become pregnant during the study.
  • You have had a brain or nerve disease other than Parkinson’s, including a stroke, major head injury, epilepsy, or seizures.
  • You have a fear of tight spaces or cannot lie on your back in an MRI scanner.
  • You have COPD, a long-term lung disease, and need oxygen.
  • You have metal implants that are not safe for MRI, such as certain surgical clips, staples, or heart pacemakers.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Subjects above 18 years of age * Individuals with a PD diagnosis as defined by the UK Brain Bank diagnostic criteria for Parkinson's disease (58) which have undergone a neurological and neuropsychological evaluation at MUSCs movement disorder center, and were selected to undergo 3T compatible unilateral or bilateral STN- DBS implants 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 that have a history of neurological disease (other than PD) including previous stroke, major head trauma, and epilepsy or seizures. * 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.)

Study sites (1)

SC