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Informed Consent Form Title: Deep Brain Stimulation for Treatment Resistant Depression: Exploration of Local Field Potentials (LFP) with the Medtronic Activa PC+S Brain Radio System NCT Number: NCT01984710
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Step 1: Start by familiarizing yourself with the closed-loop deep brain stimulation device and its components.
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Step 2: Ensure that you have the necessary medical documentation and clearance to undergo the procedure.
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Step 3: Follow the instructions provided by your healthcare professional for pre-operative preparations.
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Step 4: On the day of the procedure, an anesthesiologist will administer anesthesia to ensure your comfort.
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Step 5: The surgeon will make a small incision in your scalp and use imaging techniques to guide the placement of electrodes in the target area of your brain.
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Step 6: The electrodes will be connected to an impulse generator, which is typically implanted under the skin near your collarbone.
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Step 7: Once the device is in place, your surgeon will close the incision, and you will be taken to a recovery area.
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Step 8: You will be given post-operative instructions, including how to care for the incision site and manage any discomfort.
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Step 9: Regular follow-up appointments will be scheduled to monitor your progress and adjust the settings of the device as necessary.
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Step 10: It is crucial to follow your healthcare professional's advice and attend all recommended appointments to ensure the effectiveness of closed-loop deep brain stimulation.

Who needs closed-loop deep brain stimulation?

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Closed-loop deep brain stimulation is typically recommended for individuals with specific neurological disorders, such as Parkinson's disease, essential tremor, dystonia, and epilepsy.
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Candidates for closed-loop deep brain stimulation are usually those who have not achieved satisfactory results with medication or other conservative treatments.
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They may experience significant motor symptoms, tremors, or seizures that significantly impact their quality of life.
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A thorough evaluation by a neurologist and neurosurgeon is necessary to determine if closed-loop deep brain stimulation is a suitable option for an individual's specific condition.
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Closed-loop deep brain stimulation is a neuromodulation technique that continuously monitors brain activity and automatically adjusts stimulation parameters in real-time to optimize therapeutic effects for conditions such as Parkinson's disease and epilepsy.
Patients receiving closed-loop deep brain stimulation may be required to file reports or documentation with their healthcare providers or regulatory bodies to ensure appropriate treatment and monitoring.
Filling out closed-loop deep brain stimulation documentation typically involves providing patient information, device specifications, treatment parameters, monitoring results, and any changes made to the stimulation settings.
The purpose of closed-loop deep brain stimulation is to improve the efficacy and safety of brain stimulation therapies by allowing for personalized adjustments based on real-time feedback from the patient's brain activity.
The information that must be reported includes the patient's response to stimulation, any adverse effects, changes in stimulation parameters, and the overall effectiveness of the therapy.
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