Accelerated TMS for Apathy in Parkinson's Disease

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Severe cognitive impairment, psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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 six treatment visits over two weeks, receiving eight iTBS sessions per day. 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 two and four weeks post-treatment.

Who Is on the Research Team?

Daniel Lench

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for individuals aged 45-85 with Parkinson's Disease who feel a lack of interest or motivation (apathy). They must have stable PD medication routines and someone to provide care information. Specific scores on the Apathy Evaluation Scale are required.

Inclusion Criteria

I am between 45 and 85 years old.

I have a caregiver who can provide information about my health.

I have been diagnosed with Parkinson's Disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive accelerated iTBS rTMS targeting the left dorsomedial prefrontal cortex over 6 treatment days within approximately 2 weeks

2 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 2 and 4 weeks post-treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Accelerated intermittent theta-burst stimulation (iTBS)

Trial Overview

The study tests an accelerated brain stimulation technique called iTBS, targeting a specific area in the brain related to motivation. Participants will receive multiple sessions over two weeks, with follow-ups to measure changes in apathy and brain activity.

How Is the Trial Designed?

Group I: TMS group Experimental Treatment 1 Intervention

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 6 days over \~2 weeks (days may be non-contiguous), with 8 sessions/day separated by 10-15 min. Each session delivers 600 pulses (50 Hz triplets; 2 s on/8 s off; \~190 s), totaling 4,800 pulses/day and 28,800 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.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+