Accelerated TMS for Apathy in Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to assist people with Parkinson's Disease who experience strong feelings of apathy—a lack of interest or enthusiasm. The treatment under investigation is called accelerated iTBS (intermittent theta-burst stimulation), a type of non-invasive brain stimulation designed to boost activity in a brain area linked to motivation. Participants will attend six treatment sessions over two weeks. This trial might suit individuals with Parkinson's Disease who often feel uninterested or disengaged from daily activities and have a caregiver for support. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance the quality of life for those with Parkinson's Disease.
Do I need to stop my current medications for the trial?
The trial requires that your Parkinson's Disease medications remain stable, so you should not stop taking them.
What prior data suggests that this method is safe for treating apathy in Parkinson's Disease?
Studies have shown that intermittent theta-burst stimulation (iTBS) is generally safe and well-tolerated. The FDA has approved iTBS for treating depression, indicating a strong safety record. Research on its use for Parkinson's disease (PD) shows that patients usually handle it well, experiencing only mild side effects. Common side effects include headaches and scalp discomfort, which are typically temporary and not severe. In some studies, patients experienced minor facial twitching or felt tired after sessions. Overall, iTBS appears to be a promising and safe option for treating symptoms in PD.12345
Why are researchers excited about this trial?
Most treatments for apathy in Parkinson's disease rely on medications or behavioral therapies, but accelerated intermittent theta-burst stimulation (iTBS) offers a new approach. This treatment uses rapid magnetic pulses targeting the brain's left dorsomedial prefrontal cortex, an area linked to motivation and decision-making. Researchers are excited because iTBS can deliver results more quickly than traditional methods, with sessions spread over just two weeks. Plus, it offers a non-invasive option with the potential to significantly improve quality of life for those with Parkinson's.
What evidence suggests that accelerated iTBS is effective for apathy in Parkinson's Disease?
Research has shown that intermittent theta-burst stimulation (iTBS) can alleviate symptoms of Parkinson's Disease. In this trial, participants in the TMS group will receive accelerated iTBS targeting the left dorsomedial prefrontal cortex. One study found that iTBS improved movement problems in Parkinson's patients, especially when they were not taking their medication. Another study discovered that iTBS, when aimed at specific brain regions, could enhance motivation, which is crucial for reducing apathy. These findings suggest that iTBS might alleviate apathy by activating brain areas related to motivation and movement. Additionally, iTBS is considered safe and generally well-tolerated, with side effects such as mild headaches or scalp irritation. Overall, early results are promising for using iTBS to address apathy in Parkinson's Disease.26789
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive accelerated iTBS rTMS targeting the left dorsomedial prefrontal cortex over 6 treatment days within approximately 2 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 2 and 4 weeks post-treatment
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?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor
Citations
NCT07399496 | Accelerated TMS for Apathy in PD
This single-site, open-label pilot study will evaluate the feasibility, tolerability, and preliminary efficacy of accelerated intermittent theta ...
Accelerated TMS for Apathy in Parkinson's Disease
The study tests an accelerated brain stimulation technique called iTBS, targeting a specific area in the brain related to motivation.
a randomized, double-blind, sham-controlled, crossover trial ...
Effect of intermittent theta-burst stimulation on akinesia and sensorimotor integration in patients with Parkinson's disease. Eur. J. Neurosci. 36, 2669 ...
Effect of Theta Burst Stimulation-Patterned rTMS on Motor ...
Our study demonstrated that cTBS over the SMA could significantly improve the UPDRS-III score for PD patients in the “off,” not in the “on,” medicine state.
Clinical Efficacy of Intermittent Theta Burst Transcranial ...
This study aims to compare the symptomatic effects of different iTBS protocols on Parkinson's disease, optimize stimulation parameters, and evaluate safety, ...
Accelerated Theta Burst Stimulation (aTBS): Safety, efficacy ...
A large, multicenter clinical trial found iTBS had equivalent antidepressant efficacy to 10Hz rTMS and consequently iTBS was FDA-approved for the treatment of ...
Intermittent theta-burst transcranial magnetic stimulation for ...
To investigate the safety and efficacy of intermittent theta-burst stimulation (iTBS) in the treatment of motor symptoms in Parkinson disease (PD).
Intermittent Theta-burst Transcranial Temporal Interference ...
This study investigated intermittent theta-burst (iTBS) tTIS effects on symptom severity in Parkinson's disease (PD) and motor learning behavior ...
Accelerated Theta Burst Stimulation: Safety, Efficacy, and ...
TBS protocols have advantages over conventional rTMS protocols due to the shorter duration of stimulation sessions and apparent efficacy at lower stimulation ...
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