Active-tACS for Parkinson's (NCT06993571)
Timed stimulation reduces hand tremor
- Trial ID
- NCT06993571
- Official Title
- Closed-loop Phase-adaptive Cerebellar Transcranial Alternating Current Stimulation (tACS) to Modulate Activity in the Cerebello-thalamo-cortical Network to Reduce Parkinson's Disease Tremor
- Goal
- Timed stimulation reduces hand tremor
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Study Type
- INTERVENTIONAL
- Enrollment
- 10 participants
- Conditions
- Parkinson's Disease (PD), Tremor
- Interventions
- Active-tACS, Sham-tACS, Unlocked-tACS
Summary For Families
The goal is to reduce moderate to severe hand tremor in Parkinson's by changing activity in the cerebello-thalamo-cortical network that helps generate tremor rhythms. The approach uses noninvasive transcranial alternating current stimulation over the cerebellum, delivering weak electrical currents timed to a person’s tremor in a closed-loop, phase-adaptive way to disrupt the abnormal rhythmic brain activity that drives tremor, and because it is non-drug it can be given alongside usual medications like levodopa. Participants may be randomized to active phase-locked tACS, sham tACS, or unlocked tACS that is not phase-locked, so researchers can test whether syncing stimulation to tremor timing matters. The trial is looking for adults 18 and older with a UK Brain Bank diagnosis of Parkinson's and moderate to severe hand tremor who can consent, while excluding people with pacemakers or metal implants, other major neurological or psychiatric disorders, or pregnancy.
Locations
- Universitätsklinikum Hamburg-Eppendorf, Hamburg, Free and Hanseatic City of Hamburg, Germany
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Active-tACS. The goal is to reduce moderate to severe hand tremor in Parkinson's by changing activity in the cerebello-thalamo-cortical network that helps generate tremor rhythms. The approach uses noninvasive transcranial alternating current stimulation over the cerebellum, delivering weak electrical currents timed to a person’s tremor in a closed-loop, phase-adaptive way to disrupt the abnormal rhythmic brain activity that drives tremor, and because it is non-drug it can be given alongside usual medications like levodopa. Participants may be randomized to active phase-locked tACS, sham tACS, or unlocked tACS that is not phase-locked, so researchers can test whether syncing stimulation to tremor timing matters. The trial is looking for adults 18 and older with a UK Brain Bank diagnosis of Parkinson's and moderate to severe hand tremor who can consent, while excluding people with pacemakers or metal implants, other major neurological or psychiatric disorders, or pregnancy.
- Who can participate?
- Participants must be at least 18 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 5 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?
- The study involves two sessions.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive). Confirm the full schedule with the study coordinator.