Normal therapeutic DBS for Parkinson's (NCT06899022)
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?
- 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 2 years 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?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- How many visits does this trial involve?
- Three in-person sessions: before starting DBS (~1 hour), during the implantation surgery (no more than 15 minutes), and after starting DBS (~1 hour).
- 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.