RECRUITING

Accelerated TMS for Freezing of Gait in Parkinson's Disease

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

The goal of this clinical trial is to learn whether a personalized brain stimulation method called repetitive transcranial magnetic stimulation (rTMS), combined with walking exercises, is a practical and tolerable approach to help people with Parkinson's disease who experience freezing of gait (FOG). FOG is a disabling symptom where people temporarily feel stuck and unable to start walking, even though they want to move. The main questions this study aims to answer are: Can people with Parkinson's disease and FOG tolerate this combined rTMS and walking training procedure? Can researchers successfully enroll and retain participants for this multi-visit intervention? Does the combination of rTMS and gait training show early signs of improving gait and reducing freezing episodes? This study does not include a comparison or placebo group. All participants will receive the same intervention. Participants will: Attend up to 15 study visits over about 16 weeks, with the option to combine visits to reduce burden. Complete brain imaging (MRI) before and after the intervention to guide and evaluate treatment. Receive a form of brain stimulation (rTMS) using a safe, non-invasive coil placed over a specific part of the brain called the supplementary motor area (SMA). The target is personalized using each person's MRI data. Participate in walking exercises that include cognitive tasks (dual-task gait training) after each set of brain stimulation sessions. Undergo assessments of walking ability, Parkinson's disease symptoms, and brain response to stimulation. Be videotaped during walking tasks to assess gait changes, while wearing small motion sensors on the body. Complete questionnaires about symptoms, safety, and tolerability. This study is being conducted at the Medical University of South Carolina (MUSC) and includes up to 15 adults between the ages of 50 and 80 who have been diagnosed with Parkinson's disease and experience FOG. Although rTMS is already FDA-cleared for depression and other conditions, it has not been approved for freezing of gait, and its use in this study is considered investigational. The stimulation device used has been determined to be non-significant risk (NSR) by the FDA. The study does not offer direct medical benefit to participants, but results from this trial may help researchers develop future treatments and better understand how brain stimulation affects walking difficulties in Parkinson's disease. Participation is voluntary, and individuals can withdraw from the study at any time without affecting their medical care

Official Title

Accelerated TMS for Freezing of Gait in Parkinson's Disease

Quick Facts

Study Start:2024-11-21
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06982638

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:50 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 50-80 years of age
  2. 2. diagnosis of PD based on UK Brain Bank diagnostic criteria 55
  3. 3. presence of FOG defined as a score of 1 on part 1 of the nFOGQ in which a video showing different types of freezing is played for the patient, a score of 1 represents a positive response of having experienced such an episode over the last month
  4. 4. no dopaminergic medication changes in the month prior
  5. 5. observed FOG rated as \>1 in item 3.11 of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
  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) without assistance or assist devices
  3. 3. barriers to making contact between the TMS coil and the skin (e.g. braids that cannot be removed)
  4. 4. failing to meet all criteria on a standardized MRI/TMS safety screening: This includes, but is not limited to, the presence of claustrophobia, implanted electronic devices (e.g., pacemakers), metallic objects or fragments (e.g., bullets), and non-removable hair clips or piercings.
  5. 5. individuals with a diagnosis of psychosis or any other cognitive impairments that would make them unable to understand and follow study instructions or to consent for themselves.
  6. 6. pregnancy
  7. 7. individuals with a history of seizure

Contacts and Locations

Study Contact

Niloufar Malakouti, MD, MSc
CONTACT
843-792-0235
malakout@musc.edu

Study Locations (Sites)

Medical University of South Carlina
Charleston, South Carolina, 29414
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 Date2024-11-21
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-11-21
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • TMS
  • Parkinson's Disease (PD)
  • Gait training
  • Freezing of gait

Additional Relevant MeSH Terms

  • Parkinson's Disease (PD)