Improve targeting for brain stimulation
- Trial ID
- NCT00575081
- Official Title
- Physiological Brain Atlas Development
- Goal
- Improve targeting for brain stimulation
- Status
- RECRUITING
- Sponsor
- Vanderbilt University Medical Center
- Study Type
- OBSERVATIONAL
- Enrollment
- 5000 participants
- Conditions
- Parkinson's Disease, Obsessive Compulsive Disorder, Dystonia, Essential Tremor, Epilepsy
- Interventions
- Stereotactic brain procedures
Summary For Families
The goal is to build a detailed physiological atlas of brain signals to help surgeons find the exact spots for stereotactic procedures like deep brain stimulation, lesioning, or electrode placement in Parkinson's and related movement and seizure disorders. During the stereotactic procedures the team records electrical and other physiological signals from targeted brain areas, mapping those signals to anatomy so future treatments can be targeted more precisely; no new drug or experimental treatment is given, the study collects data during procedures you would already be having. The study is open to people aged 6 to 90 who have been recommended for and consent to a stereotactic brain procedure, and it excludes anyone not recommended or not able to give informed consent.
Locations
- Vanderbilt Univeristy, Nashville, Tennessee, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Stereotactic brain procedures. The goal is to build a detailed physiological atlas of brain signals to help surgeons find the exact spots for stereotactic procedures like deep brain stimulation, lesioning, or electrode placement in Parkinson's and related movement and seizure disorders. During the stereotactic procedures the team records electrical and other physiological signals from targeted brain areas, mapping those signals to anatomy so future treatments can be targeted more precisely; no new drug or experimental treatment is given, the study collects data during procedures you would already be having. The study is open to people aged 6 to 90 who have been recommended for and consent to a stereotactic brain procedure, and it excludes anyone not recommended or not able to give informed consent.
- Who can participate?
- Participants must be between 6 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 20 years.
- 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.