No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
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At a Glance
Age
40 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
54 (estimated)
Sponsor
Medical University of South Carolina · Other
Who this trial is looking for
This trial is looking for individuals with Parkinson's Disease who experience freezing of gait and are planning to undergo deep brain stimulation surgery. Participants will undergo assessments before and after the surgery over the course of one year.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 40 years old.
I have been diagnosed with Parkinson's Disease.
I experience freezing of gait.
I have been selected for deep brain stimulation surgery.
You may not be able to join if
I have other serious issues with walking not related to Parkinson's.
I cannot complete walking assessments without help.
I cannot have an MRI due to personal reasons.
I have a DBS device that does not work with 3 T MRI.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 Parkin…
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.
Trial Locations
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Status
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 t…
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.
Contacts
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