Improve attention during brain stimulation
- Trial ID
- NCT06899022
- Official Title
- Investigating the Role of Attention in Perceptual and Cognitive Consequences of Parkinson's Disease
- Goal
- Improve attention during brain stimulation
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Nebraska
- Study Type
- INTERVENTIONAL
- Enrollment
- 138 participants
- Conditions
- Essential Tremor, Parkinson's Disease (PD), Dystonias
- Interventions
- Normal therapeutic DBS, Reduced current DBS, Reduced frequency DBS
Summary For Families
The goal is to understand how attention changes contribute to the perceptual and cognitive problems people with Parkinson's or essential tremor sometimes experience, especially in relation to deep brain stimulation. The team will compare normal therapeutic DBS with reduced current and reduced frequency settings, since DBS delivers electrical pulses to targets like the STN, GPi, or VIM to reduce motor symptoms, and changing the strength or timing of that stimulation can alter attention, perception, and how DBS interacts with medications such as levodopa. Some participants will do perceptual tasks during awake DBS implantation with microelectrode recordings, and others will have brief, controlled adjustments to their implanted DBS while reporting judgments with a button or slider. Eligible people are age 19 to 90 with Parkinson's or essential tremor who are scheduled for new therapeutic DBS, can follow task instructions and use a button or mouse, and can tolerate short changes in stimulation; age-matched healthy controls are also recruited, while people with poor visual acuity or who cannot complete tasks are excluded.
Locations
- University of Nebraska Medical Center, Omaha, Nebraska, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Normal therapeutic DBS. The goal is to understand how attention changes contribute to the perceptual and cognitive problems people with Parkinson's or essential tremor sometimes experience, especially in relation to deep brain stimulation. The team will compare normal therapeutic DBS with reduced current and reduced frequency settings, since DBS delivers electrical pulses to targets like the STN, GPi, or VIM to reduce motor symptoms, and changing the strength or timing of that stimulation can alter attention, perception, and how DBS interacts with medications such as levodopa. Some participants will do perceptual tasks during awake DBS implantation with microelectrode recordings, and others will have brief, controlled adjustments to their implanted DBS while reporting judgments with a button or slider. Eligible people are age 19 to 90 with Parkinson's or essential tremor who are scheduled for new therapeutic DBS, can follow task instructions and use a button or mouse, and can tolerate short changes in stimulation; age-matched healthy controls are also recruited, while people with poor visual acuity or who cannot complete tasks are excluded.
- Who can participate?
- Participants must be between 19 Years and 90 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 2 years 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.