Reduce apathy and boost motivation
- Trial ID
- NCT07399496
- Official Title
- Accelerated Transcranial Magnetic Stimulation (TMS) for Apathy in Parkinson's Disease
- Goal
- Reduce apathy and boost motivation
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Medical University of South Carolina
- Study Type
- INTERVENTIONAL
- Enrollment
- 15 participants
- Conditions
- Parkinson Disease
- Interventions
- Accelerated intermittent theta-burst stimulation (iTBS) rTMS to left dorsomedial prefrontal cortex (dmPFC)
Summary For Families
Aiming to ease apathy in Parkinson's, the trial targets the lack of motivation and reduced initiative that many people experience and which often do not improve with standard motor medications. It uses accelerated intermittent theta-burst repetitive transcranial magnetic stimulation, a noninvasive series of magnetic pulses aimed at the left dorsomedial prefrontal cortex to boost activity in a brain region tied to motivation; sessions are given multiple times per day to try to speed benefit, and the therapy is added without changing your Parkinson's medications. Participants should be 45 to 85 years old, have significant apathy (AES, Apathy Evaluation Scale, ≥37), be on stable PD medications, and have a caregiver informant; people with severe cognitive impairment (MoCA <21), seizure history, certain psychiatric disorders, MRI/TMS contraindications, or pregnancy are excluded.
Locations
- Medical University of South Carolina, Charleston, South Carolina, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Accelerated intermittent theta-burst stimulation (iTBS) rTMS to left dorsomedial prefrontal cortex (dmPFC). Aiming to ease apathy in Parkinson's, the trial targets the lack of motivation and reduced initiative that many people experience and which often do not improve with standard motor medications. It uses accelerated intermittent theta-burst repetitive transcranial magnetic stimulation, a noninvasive series of magnetic pulses aimed at the left dorsomedial prefrontal cortex to boost activity in a brain region tied to motivation; sessions are given multiple times per day to try to speed benefit, and the therapy is added without changing your Parkinson's medications. Participants should be 45 to 85 years old, have significant apathy (AES, Apathy Evaluation Scale, ≥37), be on stable PD medications, and have a caregiver informant; people with severe cognitive impairment (MoCA <21), seizure history, certain psychiatric disorders, MRI/TMS contraindications, or pregnancy are excluded.
- Who can participate?
- Participants must be between 45 Years and 85 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 9 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.