Improve language processing and behavior
- 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
- Improve language processing and behavior
- 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
It aims to change activity in deep frontal and striatal brain circuits to produce immediate improvements in language processing and behavioral performance for people with mild cognitive impairment related to Parkinson's, Lewy body disease, or amnestic MCI. The approach, temporal interference stimulation, sends two high-frequency electrical currents through scalp electrodes that intersect deep in the brain to create a low-frequency modulation that can adjust neural firing in those targeted frontal and striatal areas. Participants receive either active TIS or a sham procedure so researchers can compare real versus placebo effects, and because TIS targets cognitive circuits it is not meant to replace or directly interact with dopaminergic drugs like levodopa. The study is looking for people aged 60 to 80 with MCI-PD, MCI-LB, or aMCI, and excludes those with severe psychiatric illness, other neurologic diseases, major head trauma, uncompensated medical or cancer conditions, or MRI-incompatible metal implants.
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). It aims to change activity in deep frontal and striatal brain circuits to produce immediate improvements in language processing and behavioral performance for people with mild cognitive impairment related to Parkinson's, Lewy body disease, or amnestic MCI. The approach, temporal interference stimulation, sends two high-frequency electrical currents through scalp electrodes that intersect deep in the brain to create a low-frequency modulation that can adjust neural firing in those targeted frontal and striatal areas. Participants receive either active TIS or a sham procedure so researchers can compare real versus placebo effects, and because TIS targets cognitive circuits it is not meant to replace or directly interact with dopaminergic drugs like levodopa. The study is looking for people aged 60 to 80 with MCI-PD, MCI-LB, or aMCI, and excludes those with severe psychiatric illness, other neurologic diseases, major head trauma, uncompensated medical or cancer conditions, or MRI-incompatible metal implants.
- 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?
- 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 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.