Accelerated TMS for Freezing of Gait in Parkinson's Disease
ConditionParkinson's Disease (PD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorMedical University of South Carolina
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
50-80 years of age
diagnosis of PD based on UK Brain Bank diagnostic criteria 55
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
no dopaminergic medication changes in the month prior
Disqualifiers
a history of other significant gait impairment unrelated to PD (e.g. orthopedic deformities)
inability to complete gait assessments (timed up and go task) without assistance or assist devices
barriers to making contact between the TMS coil and the skin (e.g. braids that cannot be removed)
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.
Trial design
Design model
Single group
Treatments tested in this trial
TMS+ Gait training
DeviceParticipants in this single-arm study will receive a personalized, accelerated course of continuous theta burst stimulation (cTBS) over a functionally defined subregion of the supplementary motor area (SMA), which is individually targeted using resting-state functional MRI. The stimulation will be delivered using a MagPro Cool-B65 A/P figure-of-eight coil at 110% of resting motor threshold. Each participant will undergo 6 treatment visits over 2 weeks , receiving 8 rTMS sessions per day (600 pulses/session), totaling 28,800 pulses across the study. TMS sessions will be interleaved with dual-task gait training involving cognitive walking exercises. Gait training will be conducted for 30 minutes per visit, immediately following stimulation blocks. Safety, tolerability, adherence, gait performance, and neuroplasticity will be evaluated pre- and post-intervention using clinical scales, motor evoked potentials (MEPs), and functional MRI.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: TMS+Gait trainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Tolerability of the Intervention
Participant-reported discomfort after each TMS session using a modified version of the Non-Invasive Brain Stimulation (NIBS) Tolerability Questionnaire, which rates six side effects (headache, pain, scalp irritation, facial twitching, fatigue, fear/anxiety) from 1 (Mild) to 10 (Severe).
Time frame
Immediately after each TMS session during the 6 treatment days2
Adherence to Study Visits
The proportion of scheduled study visits completed by each participant, calculated as the number of attended sessions divided by the number of planned sessions.
Time frame
Across the total study duration, up to 16 weeksSecondary outcomes
1
Change in Freezing of Gait Questionnaire Scores (nFOG-Q)
Difference in participant-reported FOG severity using the New Freezing of Gait Questionnaire (nFOG-Q) from baseline to post-intervention.
Time frame
nFOG-Q will be assessed at 5 time points: 1)Baseline 2) immediately after completion of intervention 3) one month after completion of intervention, 4)two months after completion of intervention 5) three months after completion of intervention2
Change in MDS-UPDRS Gait Item Scores
Changes in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) gait-related items, especially item 3.11 (FOG), assessed before and after the intervention.
Time frame
Baseline and after completion of intervention, up to 16 weeks3
Change in SMA Functional Connectivity
Pre-to-post change in resting-state fMRI connectivity between the supplementary motor area (SMA) and other brain regions, particularly the cerebellar locomotor region (CLR).
Time frame
Baseline and after completion of intervention, up to 16 weeksOther outcomes
1
Cortical Plasticity via MEP Amplitude Changes
Change in motor evoked potential (MEP) amplitude following administration of continuous and intermittent theta burst stimulation (cTBS and iTBS) over the motor cortex, measured at 0, 5, 10, 15, 20, and 30 minutes post-stimulation.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov