Understanding how Deep Brain Stimulation affects Freezing of Gait in Parkinson's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to recruit 54 individuals with Parkinson's Disease who experience Freezing of Gait (FOG) and are scheduled for Deep Brain Stimulation (DBS). Participants will undergo a series of assessments, including MRI scans and behavioral evaluations, both before and after the DBS procedure over the course of one year. The goal is to develop a personalized treatment approach for FOG by examining the relationship between brain structure, stimulation parameters, and patient responses. This research will help clarify how DBS can be optimized for individuals suffering from FOG.

Why it matters

Who can join: the full rules

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.

Where it's running

• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.