Personalized brain stimulation and walking exercises for freezing of gait in Parkinson's disease
Accelerated TMS for Freezing of Gait in Parkinson's Disease
This study is testing if a mix of brain stimulation and walking exercises can help people with Parkinson's disease who struggle with freezing while walking.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06982638 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a personalized brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) combined with walking exercises for individuals with Parkinson's disease who experience freezing of gait (FOG). Participants will undergo up to 15 study visits over approximately 16 weeks, where they will receive the combined intervention without a comparison or placebo group. The study seeks to determine the tolerability of this approach and whether it can lead to improvements in gait and a reduction in freezing episodes. The primary focus is on participant retention and the feasibility of the intervention.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50-80 with a diagnosis of Parkinson's disease and a history of freezing of gait.
Not a fit: Patients with significant gait impairments unrelated to Parkinson's disease or those unable to complete gait assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve mobility and quality of life for patients with Parkinson's disease experiencing freezing of gait.
How similar studies have performed: While the combination of rTMS and gait training is a novel approach, similar studies have shown promise in using rTMS for various neurological conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 50-80 years of age 2. diagnosis of PD based on UK Brain Bank diagnostic criteria 55 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. no dopaminergic medication changes in the month prior 5. observed FOG rated as \>1 in item 3.11 of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS). 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) without assistance or assist devices 3. barriers to making contact between the TMS coil and the skin (e.g. braids that cannot be removed) 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. 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. pregnancy 7. individuals with a history of seizure
Where this trial is running
Charleston, South Carolina
- Medical University of South Carlina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Niloufar Malakouti, MD, MSc
- Email: malakout@musc.edu
- Phone: 843-792-0235
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.