Accelerated TMS for Apathy in Parkinson's Disease
This study is exploring a new way to help people with Parkinson's disease (PD) who experience apathy, which is a loss of motivation or interest. Researchers are testing a non-invasive brain stimulation technique called accelerated intermittent theta-burst stimulation (iTBS) rTMS. This treatment uses magnetic pulses to specific brain areas linked to motivation. The study aims to see if this treatment is safe, acceptable, and can help improve apathy in 15 participants with PD. You might be able to join if you are 45-85 years old, have Parkinson's disease with significant apathy, and a caregiver available. The study will measure how well participants tolerate the treatment, any side effects, and changes in apathy levels. This is a pilot study, meaning it's an early step to see if a larger study is warranted.
- Study design
- This is an open-label pilot study, meaning everyone knows what treatment is being given, and it plans to enroll 15 participants.
- What's involved
- You would have six treatment days over about two weeks, with eight short treatment sessions each day. There will also be follow-up assessments after treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would have follow-up assessments two weeks and four weeks after your treatment ends.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Accelerated rTMS for Apathy in Parkinson's Disease
At a glance
Conditions
NCT07399496
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Medical University of South Carolina
Charleston, South Carolinastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Daniel Lench · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina
Who to contact
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Inclusion
Exclusion
What this trial measures
- TMS adherenceDay 1 through Day 14 (6 treatment days over approximately 2 weeks)
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).
- Frequency and Severity of TMS-Induced Side effects (TMS tolerability and acceptability)Measured during each treatment day (6 days within a 2-week period)
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).
- Apathy severity as measured by the Lille Apathy Rating ScaleBaseline (Day 0), immediately post-treatment (Day 14), 2 weeks post-treatment, and 4 weeks post-treatment
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.
- Target engagement (dmPFC network modulation)Baseline MRI/EEG assessments (Days 0-1) and post-treatment MRI/EEG assessments (Days 14-15)
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.