Active Temporal Interference Stimu… for Parkinson's (NCT07449117)
Brain stimulation improves sentence understanding
- Trial ID
- NCT07449117
- Official Title
- Immediate Effects of Non-invasive Temporal Interference Stimulation Targeting Deep Fronto-Striatal Structures on Language Processing and Behavioral Performance in Patients With Neurodegenerative Diseases
- Goal
- Brain stimulation improves sentence understanding
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Masaryk University
- Study Type
- INTERVENTIONAL
- Enrollment
- 70 participants
- Conditions
- Mild Cognitive Impairment (MCI) Amnestic, Lewy Body Disease With Mild Cognitive Impairment, Parkinson's Disease With Mild Cognitive Impairment
- Interventions
- Active Temporal Interference Stimulation (TIS), Placebo / Sham TIS
Summary For Families
This trial is testing whether a short, non-invasive brain stimulation aimed at deep language circuits can improve sentence understanding and change how those brain areas connect in people with neurodegenerative diseases who have trouble communicating. Participants take part in two 20-minute sessions in random order, one with active temporal interference stimulation aimed at the striatum and one with a placebo (sham) session, while doing a sentence comprehension task, and they get brain scans before and after to look for immediate changes in resting brain connectivity and possible short-term adaptation. The study is enrolling people aged 60 to 80 with mild cognitive problems due to Lewy body disease, Parkinson’s disease, or amnestic mild cognitive impairment, and excludes those with severe psychiatric or other neurological illness, major head injury, uncontrolled medical or cancer disease, or metal in the body that prevents magnetic resonance imaging.
Locations
- CEITEC MU (Central European Institute of Technology, Masaryk University), Brno, South Moravian, Czechia
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Active Temporal Interference Stimulation (TIS). This trial is testing whether a short, non-invasive brain stimulation aimed at deep language circuits can improve sentence understanding and change how those brain areas connect in people with neurodegenerative diseases who have trouble communicating. Participants take part in two 20-minute sessions in random order, one with active temporal interference stimulation aimed at the striatum and one with a placebo (sham) session, while doing a sentence comprehension task, and they get brain scans before and after to look for immediate changes in resting brain connectivity and possible short-term adaptation. The study is enrolling people aged 60 to 80 with mild cognitive problems due to Lewy body disease, Parkinson’s disease, or amnestic mild cognitive impairment, and excludes those with severe psychiatric or other neurological illness, major head injury, uncontrolled medical or cancer disease, or metal in the body that prevents magnetic resonance imaging.
- Who can participate?
- Participants must be between 60 Years and 80 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 9 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.
- How many visits does this trial involve?
- Participants will undergo a single session of active TIS and a session of placebo stimulation; the duration of the stimulation is approximately 20 minutes.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: MRI scan (non-invasive). Confirm the full schedule with the study coordinator.
- Is there a medication washout in this trial?
- There is a washout period between the active and placebo sessions.