Imaging Biomarkers of FOG Response to DBS
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorMedical University of South Carolina
About this trial
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.
Eligibility criteria
Qualifiers
>40 years of age.
diagnosis of PD based on UK Brain Bank diagnostic criteria.
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).
clinically selected at the MUSC DBS Conference to undergo STN-DBS surgery.
Disqualifiers
a history of other significant gait impairment unrelated to PD (e.g. orthopedic deformities).
inability to complete gait assessments (timed-up-and-go task) in the OFF state without assistance or assist devices.
contraindications to MRI, including inability to lie supine in the scanner environment, pregnancy, and non-MRI compatible metal implants.
implantation of non-3 T MRI-compatible DBS devices.
Trial design
Treatments tested in this trial
- fMRI
Treatment groups
54 Participants
are divided into 1 treatment groupSponsors and collaborators
Medical University of South Carolina
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov