RECRUITING

Imaging Biomarkers of FOG Response to DBS

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Imaging Biomarkers of Freezing of Gait Response to Deep Brain Stimulation

Quick Facts

Study Start:2024-11-11
Study Completion:2030-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06951906

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. \>40 years of age.
  2. 2. diagnosis of PD based on UK Brain Bank diagnostic criteria.
  3. 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. 4. clinically selected at the MUSC DBS Conference to undergo STN-DBS surgery.
  1. 1. a history of other significant gait impairment unrelated to PD (e.g. orthopedic deformities).
  2. 2. inability to complete gait assessments (timed-up-and-go task) in the OFF state without assistance or assist devices.
  3. 3. contraindications to MRI, including inability to lie supine in the scanner environment, pregnancy, and non-MRI compatible metal implants.
  4. 4. implantation of non-3 T MRI-compatible DBS devices.

Contacts and Locations

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-11
Study Completion Date2030-01

Study Record Updates

Study Start Date2024-11-11
Study Completion Date2030-01

Terms related to this study

Keywords Provided by Researchers

  • Freezing of Gait
  • Parkinson's Disease
  • Deep Brain Stimulation

Additional Relevant MeSH Terms

  • Freezing of Gait Symptoms in Parkinson's Disease
  • Deep Brain Stimulation