5Hz stimulation on the STN motor s… for Parkinson's (NCT07022522)

Improve stopping of impulsive actions

Trial ID
NCT07022522
Official Title
Frequency-dependent Modulation of Inhibitory Control Via Subthalamic Nucleus Subregional Stimulation in Parkinson's Disease
Goal
Improve stopping of impulsive actions
Phase
NA
Status
RECRUITING
Sponsor
Beijing Tiantan Hospital
Study Type
INTERVENTIONAL
Enrollment
20 participants
Conditions
Parkinson Disease, Deep Brain Stimulation
Interventions
5Hz stimulation on the STN motor subregion, 5Hz stimulation on the STN associative subregion, 130Hz stimulation on the STN motor subregion, 130Hz stimulation on the STN associative subregion, No stimulation

Summary For Families

The goal is to find ways to improve inhibitory control, the ability to stop impulsive actions and stay focused, which often declines in Parkinson's and greatly hurts quality of life. The team will compare low-frequency (5 Hz) and high-frequency (130 Hz) electrical stimulation applied to two different parts of the subthalamic nucleus, the brain target used in deep brain stimulation, and will measure performance on stopping and distraction tests (Arrow Flanker and Stop-Signal) to see which site and frequency help. This follows observations that high-frequency stimulation helps movement but may worsen thinking over time, while low-frequency stimulation has shown benefits for memory and word-finding. The study is looking for people aged 40 to 80 with idiopathic Parkinson's who meet the usual criteria for subthalamic deep brain stimulation, and it excludes those with major psychiatric illness, dementia by memory-test cutoffs, sensory problems that would affect testing, or serious post-surgery complications.

Locations

  • Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing Municipality, China

Frequently Asked Questions

What is this trial testing?
This trial is studying 5Hz stimulation on the STN motor subregion. The goal is to find ways to improve inhibitory control, the ability to stop impulsive actions and stay focused, which often declines in Parkinson's and greatly hurts quality of life. The team will compare low-frequency (5 Hz) and high-frequency (130 Hz) electrical stimulation applied to two different parts of the subthalamic nucleus, the brain target used in deep brain stimulation, and will measure performance on stopping and distraction tests (Arrow Flanker and Stop-Signal) to see which site and frequency help. This follows observations that high-frequency stimulation helps movement but may worsen thinking over time, while low-frequency stimulation has shown benefits for memory and word-finding. The study is looking for people aged 40 to 80 with idiopathic Parkinson's who meet the usual criteria for subthalamic deep brain stimulation, and it excludes those with major psychiatric illness, dementia by memory-test cutoffs, sensory problems that would affect testing, or serious post-surgery complications.
Who can participate?
Participants must be between 40 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 4 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); Surgical procedure (invasive). Confirm the full schedule with the study coordinator.

Related Reading

View on ClinicalTrials.gov