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Scalar ClosedLoop STN/GPS DBS Based on Evoked and Spontaneous Potentials (Permanently Implanted Medtronic RC’S Studies) NCT03815656 Document Date: April 30, 2021Form M0345DUKE UNIVERSITY HEALTH

How to fill out closed-loop deep brain stimulation

How to fill out closed-loop deep brain stimulation

1. To fill out closed-loop deep brain stimulation, follow these steps:
2. Prepare all necessary equipment, including the neurostimulator device and the accompanying software.
3. Ensure that the patient is in a comfortable position and properly sedated if necessary.
4. Perform a thorough pre-procedure evaluation to determine the target area in the brain for stimulation.
5. Sterilize the surgical site and administer local anesthesia.
6. Make a small incision in the scalp and drill a tiny hole into the skull to access the brain.
7. Carefully place the electrodes at the predetermined target location within the brain.
8. Connect the neurostimulator device to the electrodes securely.
9. Close the incision and ensure that everything is properly sealed and protected.
10. Program the neurostimulator device with the appropriate stimulation parameters based on the patient's specific condition.
11. Regularly monitor and adjust the stimulation settings as necessary to optimize the therapeutic effects.
12. Educate the patient and/or caregiver about post-operative care and any potential side effects or complications.
13. Note: It is essential to follow the guidelines and instructions provided by the manufacturer and consult with a qualified healthcare professional before attempting to fill out closed-loop deep brain stimulation.

Who needs closed-loop deep brain stimulation?

1. Closed-loop deep brain stimulation is recommended for individuals who meet certain criteria, including:
2. - Diagnosed with Parkinson's disease or essential tremor that is not adequately controlled with medication alone.
3. - Experiencing significant movement disorders, such as dyskinesia, dystonia, or tremors, that severely impact their quality of life.
4. - Willing to undergo brain surgery and commit to long-term follow-up care.
5. - Unable to achieve satisfactory symptom relief with other treatments or therapies.
6. - Have been carefully evaluated by a multidisciplinary team of healthcare professionals to determine the potential benefits and risks of closed-loop deep brain stimulation.
7. It is important for patients to consult with their healthcare provider to determine if closed-loop deep brain stimulation is an appropriate treatment option for their specific condition.

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What is closed-loop deep brain stimulation?

Closed-loop deep brain stimulation is a neurostimulation technique that continuously monitors brain activity and adjusts electrical stimulation in real-time to optimize therapeutic effects for conditions like Parkinson's disease and epilepsy.

Who is required to file closed-loop deep brain stimulation?

Typically, medical device manufacturers and healthcare providers who use closed-loop deep brain stimulation systems must file the necessary documentation with regulatory bodies.

How to fill out closed-loop deep brain stimulation?

To fill out the closed-loop deep brain stimulation documentation, one must provide detailed information about the device, procedural descriptions, patient data, and outcomes as required by regulatory guidelines.

What is the purpose of closed-loop deep brain stimulation?

The purpose of closed-loop deep brain stimulation is to provide targeted, adaptive therapy that responds to the patient's neural activity, improving treatment efficacy while minimizing side effects.

What information must be reported on closed-loop deep brain stimulation?

Reported information typically includes device specifications, patient demographics, clinical outcomes, any adverse events, and adjustments made to the stimulation settings.