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
This trial does not accept healthy volunteersQualifiers
>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
Design model
Single group
Treatments tested in this trial
fMRI
Diagnostic testBaseline imaging will utilize advanced diffusion MRI metrics to determine which brain areas are structurally connected to the stimulation target and their structural integrity. Post-operative assessments will include behavioral measures of FOG response and imaging measures of neural response to stimulation. Pre- and post-operative data will be used to evaluate the association between structural integrity, connectivity and behavioral response.
Treatment groups
54 Participants
are divided into 1 treatment groupGroup A: PD Patients with FOG undergoing DBSActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Turn Duration
Turn duration is measured during the timed up and go (TUG) task. Subjects are instrumented with inertial measurement units (IMUs), and turn duration is measured from the first step onto a marked box to the last toe off the box during the turn.
Time frame
Assessed at Baseline (Visit 3) and at 12 months post-activation (Visit 7)2
Difference in BOLD Response to STN-DBS
Whole-brain activation is assessed via BOLD signal changes associated with T2\*-relaxation rate during combined Deep Brain Stimulation and functional MRI (DBS-fMRI). This involves cycling the DBS device ON and OFF during resting-state scans
Time frame
Assessed post-operatively at 6 months (Visit 5) and 12 months (Visit 6).3
Difference in Structural Connectivity
Structural connectivity profiles are determined using individual structural connectivity data and the Volume of Tissue Activated (VTA) model, which accounts for stimulation settings and lead placement. The outcome is the comparison of VTA connectivity to specific brain regions (e.g., GPi, SMA, M1, GPe) between STN-DBS responsive and unresponsive participants.
Time frame
Based on baseline diffusion MRI data (Visit 4) and analyzed in relation to DBS response determined at 12 months post-activation.4
Difference in Structural Integrity
Microstructural integrity of brain structures (e.g., STN, GPi, PPN) is assessed using advanced diffusion MRI metrics, specifically Diffusional Kurtosis Imaging (DKI). The outcome is the comparison of these metrics between STN-DBS responsive and unresponsive participants.
Time frame
Based on baseline diffusion MRI data (Visit 4) and analyzed in relation to DBS response determined at 12 months post-activation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of South Carolina
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov