An interventional study of Accelerated intermittent theta-burst stimulation (iTBS) rTMS to left dorsomedial prefrontal cortex (dmPFC) in Parkinson Disease and Apathy, sponsored by Medical University of South Carolina. Recruiting at 1 site in United States. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
…and 6 more changes, on the record history on ClinicalTrials.gov ↗
This single-site, open-label pilot study will evaluate the feasibility, tolerability, and preliminary efficacy of accelerated intermittent theta-burst stimulation (iTBS) targeting the dorsomedial prefrontal cortex (dmPFC) for apathy in individuals with Parkinson's Disease (PD). Fifteen participants with PD and clinically significant apathy will undergo imaging (EEG and MRI) and one day of TMS including twelve iTBS sessions across two visits. Outcomes include adherence, tolerability, changes in apathy (Lille Apathy Rating Scale), functional engagement, and neural target engagement assessed via resting-state fMRI and EEG. Follow-up assessments will occur at one week, two weeks, and four weeks post-treatment. Fifteen participants with PD without clinically significant apathy will act as a comparison group and will undergo imaging (EEG and MRI), assessments, and questionnaires at baseline. Caregivers for each participant will complete questionnaires regarding their co-participant's symptoms as well as answer questions about their experience as a caregiver.
This study is designed to explore a new treatment option for people with Parkinson's disease who experience apathy, which means loss of motivation or interest in daily activities. Apathy is common in Parkinson's disease and can lower quality of life, but current treatments are limited. Investigators are testing whether a non-invasive brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) is tolerable, acceptable and can be used to improve apathy in patients with Parkinson's disease. TMS delivers brief magnetic pulses to specific areas of the brain that are linked to motivation and decision-making. In this study, Investigators will use an "accelerated" version of TMS, which gives several short sessions in a single day, reducing the number of visits required. The purpose of this research is to see whether this treatment approach is feasible, tolerable and and potentially effective at treating apathy in people with Parkinson's disease. If successful, this research study will hopefully lead to a larger study in the future where the efficacy of the treatments can be studied.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
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The criteria were revised on the registry on Nov 5, 2026. See what changed
PD Apathy Participant
Inclusion criteria:
Exclusion Criteria:
Co-participant/Caregiver
Inclusion Criteria:
Exclusion criteria:
1) Unable to engage with study procedures in which co-participant input is needed.
PD Control Group
Inclusion Criteria:
Exclusion Criteria:
Co-participant/Caregiver
Inclusion Criteria:
3) 18 years of age or older 4) Is a reliable informant who has at least weekly contact with the participant and can speak to the participant's mood and everyday functioning.
Exclusion criteria:
2) Unable to engage with study procedures in which co-participant input is needed.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with Parkinson's disease and clinically significant apathy receive accelerated iTBS rTMS targeting the left dorsomedial prefrontal cortex (dmPFC) using a MagVenture MagPro system with a cooled figure-of-eight coil and Brainsight neuronavigation (slightly off midline). Resting motor threshold (rMT) is determined on the first stimulation visit (PEST) and stimulation is delivered at 120% rMT. Treatment occurs on one day, with 12 sessions separated by 10-15 min. Each session delivers 600 pulses (50 Hz triplets; 2 s on/8 s off; \~190 s), totaling 7,200 pulses overall. Coil position/angle and scalp-to-cortex distance are tracked; tolerability/acceptability (headache, pain, scalp irritation, facial twitching, fatigue, fear/anxiety) is assessed before/after sessions.
Device: Accelerated intermittent theta-burst stimulation (iTBS) rTMS to left dorsomedial prefrontal cortex (dmPFC)
Participants with Parkinson's Disease without clinically significant apathy will not undergo TMS but will act as a comparison group at baseline. This group will undergo imaging (EEG and MRI), assessments, and answer questionnaires with their caregiver.
Accelerated intermittent theta-burst stimulation (iTBS) rTMS to left dorsomedial prefrontal cortex (dmPFC) (MagVenture MagPro with cooled figure-of-eight coil; Brainsight neuronavigation; 120% rMT; 1 treatment day; 12 sessions; 600 pulses/session; 10-15 min inter-session interval).
TMS adherence
Proportion of planned accelerated iTBS sessions completed. Adherence is calculated as number of iTBS sessions completed out of 48 scheduled sessions (6 treatment days × 8 sessions/day).
Time frame: Day 1 through Day 14 (6 treatment days over approximately 2 weeks)
Frequency and Severity of TMS-Induced Side effects (TMS tolerability and acceptability)
Participant-reported tolerability/acceptability assessed with a standardized questionnaire capturing frequency and severity of common TMS side effects (e.g., headache, pain, scalp irritation, facial twitching, fatigue, fear/anxiety), collected during treatment days (pre/post sessions).
Time frame: Measured during each treatment day (6 days within a 2-week period)
Apathy severity as measured by the Lille Apathy Rating Scale
Change in apathy measured by the Lille Apathy Rating Scale (LARS) patient and caregiver/informant versions; analyzed as change from baseline to post-treatment and follow-up timepoints. Possible scores range from -36 to 36 with higher scores indicating greater apathy.
Time frame: Baseline (Day 0), immediately post-treatment (Day 14), 2 weeks post-treatment, and 4 weeks post-treatment
Target engagement (dmPFC network modulation)
Change in dmPFC target engagement measured by (1) resting-state fMRI functional connectivity of dmPFC to motivation/effort-related nodes and (2) EEG waveform/response metrics during motivation/effort tasks, comparing pre- vs post-intervention.
Time frame: Baseline MRI/EEG assessments (Days 0-1) and post-treatment MRI/EEG assessments (Days 14-15)
Goal attainment
Change in goal-directed behavior measured by Bangor Goal-Setting Interview outcomes, including proportion/percent attainment of individualized goals across assessment timepoints.
Time frame: Baseline (Day 0), immediately post-treatment (Day 14), 2 weeks post-treatment, and 4 weeks post-treatment
Change in apathy as measured by the Dimensional Apathy Scale
Change in apathy-related symptoms measured using the Dimensional Apathy Scale (DAS), including patient/informant reports where applicable. Scores range from 0-24 on each of the three subscales (executive, emotional, and behavior/ cognitive initiation) with higher scores indicating greater apathy.
Time frame: Baseline (Day 0), immediately post-treatment (Day 14), 2 weeks post-treatment, and 4 weeks post-treatment"
Change in apathy-related behavior as measured by the Frontal Systems Behavior Scale
Change in apathy-related symptoms measured using the Frontal Systems Behavior Scale (FRSBE), including patient/informant reports where applicable. Apathy components include 14 questions scored 0-4 for a range of scores 0-56 with higher scores indicating greater apathy.
Time frame: Baseline (Day 0), immediately post-treatment (Day 14), 2 weeks post-treatment, and 4 weeks post-treatment"
…and 6 more changes, on the record history on ClinicalTrials.gov ↗
…and 6 more changes, on the record history on ClinicalTrials.gov ↗
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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