Reduce freezing through brain stimulation
- Trial ID
- NCT06505460
- Official Title
- Exploring the Possible Beneficial Impact of Non-invasive and Invasive Neuromodulation on Freezing of Gait in Parkinson's Disease During Different Ambulatory Complexities: An Electrophysiological and fMRI Study
- Goal
- Reduce freezing through brain stimulation
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- China Medical University Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 20 participants
- Conditions
- Transcranial Direct Current Stimulation
- Interventions
- Transcranial direct current stimulation
Summary For Families
The goal is to reduce or better understand freezing of gait, the sudden, brief inability to step that many people with Parkinson's experience, especially during more challenging walking situations. The approach uses transcranial direct current stimulation, a gentle, non-invasive electrical current applied across the scalp to increase or decrease activity in brain regions that control walking, and compares effects in people with or without invasive neuromodulation like MR-guided focused ultrasound or deep brain stimulation while recording EEG and fMRI. tDCS is being tested as an add-on to usual treatments such as levodopa, not a replacement, and the team looks at how brain activity and gait change when medications are stable. About 20 adults aged 20 to 90 are being enrolled; eligible people include MRgFUS patients whose symptoms are not controlled by optimal medications and who have had stable meds for at least 30 days, and DBS patients with over 5 years of PD, clear levodopa responsiveness, and motor complications; exclusions include severe heart failure, metastatic cancer, Hoehn and Yahr stage 5, and for DBS candidates overt dementia or major depression.
Locations
- China Medical University Hospital/Neuro Depart, Taichung, Taiwan
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Transcranial direct current stimulation. The goal is to reduce or better understand freezing of gait, the sudden, brief inability to step that many people with Parkinson's experience, especially during more challenging walking situations. The approach uses transcranial direct current stimulation, a gentle, non-invasive electrical current applied across the scalp to increase or decrease activity in brain regions that control walking, and compares effects in people with or without invasive neuromodulation like MR-guided focused ultrasound or deep brain stimulation while recording EEG and fMRI. tDCS is being tested as an add-on to usual treatments such as levodopa, not a replacement, and the team looks at how brain activity and gait change when medications are stable. About 20 adults aged 20 to 90 are being enrolled; eligible people include MRgFUS patients whose symptoms are not controlled by optimal medications and who have had stable meds for at least 30 days, and DBS patients with over 5 years of PD, clear levodopa responsiveness, and motor complications; exclusions include severe heart failure, metastatic cancer, Hoehn and Yahr stage 5, and for DBS candidates overt dementia or major depression.
- Who can participate?
- Participants must be between 20 Years and 90 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 1 year and 3 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.