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RecruitingPhase 4

Imaging Biomarkers of FOG Response to DBS

Imaging Biomarkers of Freezing of Gait Response to Deep Brain Stimulation

Who can join

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

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not 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

  • Visits mentioned: 7 visits
  • 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
  • "Overall, participants will complete a total of 7 visits over a period of approximately 1 year."
  • "Baseline imaging will utilize advanced diffusion MRI metrics to determine which brain areas are structurally connected to the stimulation target and their structural integrity."
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) affects freezing of gait in people with Parkinson’s disease. Freezing of gait means feeling stuck when trying to walk. People planning DBS surgery will have MRI scans and tests of walking, thinking, and other symptoms over 7 visits in about 1 year.

For this study, the investigators are recruiting 54 individuals with Parkinson's Disease and Freezing of Gait (FOG) who are planning to undergo Deep Brain Stimulation (DBS). The objective of this study is to better understand the FOG response to DBS. Prior to DBS, participants will undergo an MRI scan, behavioral assessment related to walking, a cognitive evaluation, and assessment of other Parkinson's disease symptoms. Following DBS, participants will repeat these assessments at multiple timepoints over the period of one year. Overall, participants will complete a total of 7 visits over a period of approximately 1 year.

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

Eligibility

Who can join

  • Be older than 40.
  • Have Parkinson’s disease diagnosed using UK Brain Bank rules.
  • Have had freezing of gait in the past month, shown by a score of 1 on part 1 of the nFOGQ walking survey and confirmed by a walking check.
  • Have been chosen at the MUSC DBS Conference for DBS surgery targeting a brain area called the subthalamic nucleus (STN).

Who can't join

  • Have a history of major walking problems not caused by Parkinson’s disease, such as bone or joint problems.
  • Cannot finish a timed test of standing up and walking without help or walking aids when Parkinson’s medicine is not working well (the OFF state).
  • Cannot safely have an MRI scan, including because of pregnancy, metal implants that are not MRI-safe, or being unable to lie on your back in the scanner.
  • Have a DBS device implanted that is not safe for a 3-tesla (3 T) MRI scanner.

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

Official eligibility criteria

Inclusion Criteria: 1. \>40 years of age. 2. diagnosis of PD based on UK Brain Bank diagnostic criteria. 3. presence of FOG, defined as a score of 1 on part 1 of the nFOGQ and confirmed by objective evaluation (a score of 1 represents a positive response of having experienced such an episode over the last month). 4. clinically selected at the MUSC DBS Conference to undergo STN-DBS surgery. Exclusion Criteria: 1. a history of other significant gait impairment unrelated to PD (e.g. orthopedic deformities). 2. inability to complete gait assessments (timed-up-and-go task) in the OFF state without assistance or assist devices. 3. contraindications to MRI, including inability to lie supine in the scanner environment, pregnancy, and non-MRI compatible metal implants. 4. implantation of non-3 T MRI-compatible DBS devices.

Study sites (1)

SC