Personalized brain stimulation and walking exercises for freezing of gait in Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.