Transcranial direct current stimul… for Parkinson's (NCT06505460)
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 3 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- This is a crossover trial: instead of staying in one group, you move through a sequence of assignments, so you receive the active treatment during at least one period of the study. It also includes a placebo or sham phase, so you would be on that during another period. Ask the coordinator for the exact sequence and how long each phase lasts.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); MRI scan (non-invasive); Brain wave recording (EEG) (non-invasive); Ultrasound (non-invasive). Confirm the full schedule with the study coordinator.