Improve ability to stop actions

Trial ID
NCT07022522
Official Title
Frequency-dependent Modulation of Inhibitory Control Via Subthalamic Nucleus Subregional Stimulation in Parkinson's Disease
Goal
Improve ability to stop 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 learn how changing the frequency and exact spot of deep brain stimulation in the subthalamic nucleus affects inhibitory control, meaning the ability to stop or suppress actions that can be harder with Parkinson's. Researchers will apply brief electrical pulses to either the STN motor or associative subregion at low frequency (5 Hz) or high frequency (130 Hz), or leave stimulation off, and compare how those settings change stopping ability; high-frequency STN stimulation generally suppresses abnormal motor firing, while low-frequency pulses can recruit different circuits that may alter cognitive control and impulsivity. The trial is looking for people 40 to 80 years old with idiopathic Parkinson's who meet indications for DBS surgery, excluding those with major psychiatric illness or dementia, significant post-DBS complications, or sensory problems that would affect the cognitive tests.

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 learn how changing the frequency and exact spot of deep brain stimulation in the subthalamic nucleus affects inhibitory control, meaning the ability to stop or suppress actions that can be harder with Parkinson's. Researchers will apply brief electrical pulses to either the STN motor or associative subregion at low frequency (5 Hz) or high frequency (130 Hz), or leave stimulation off, and compare how those settings change stopping ability; high-frequency STN stimulation generally suppresses abnormal motor firing, while low-frequency pulses can recruit different circuits that may alter cognitive control and impulsivity. The trial is looking for people 40 to 80 years old with idiopathic Parkinson's who meet indications for DBS surgery, excluding those with major psychiatric illness or dementia, significant post-DBS complications, or sensory problems that would affect the cognitive tests.
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?
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 4 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.

Related Reading

View on ClinicalTrials.gov