Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Deep Brain Stimulation
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Outcomes Assessor)Masking Description: blinded: The participant , the neurologist, the neurophysiologist and neuropsychologist treating the participant will be blinded to the randomization arm. The neurosurgeon and anesthesiologist assigned to the patient will be unblinded to the randomization armPrimary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 85 years
Gender
Both males and females

Description

On the day before surgery the participant will be shown 10 objects that he should remember. On the day after surgery he will be requested to recall the objects he remembers and to answer the level of anxiety he is feeling using the Visual Anxiety Scale. In the event of discharges (a possible side ef...

On the day before surgery the participant will be shown 10 objects that he should remember. On the day after surgery he will be requested to recall the objects he remembers and to answer the level of anxiety he is feeling using the Visual Anxiety Scale. In the event of discharges (a possible side effect of ketamine due to muscarinic / parasympathetic stimulation), a single dose of scopolamine (1 mg - ) will be given intravenously. At the end of the surgical phase of opening (of the same side being operated on) the propopol will be discontinued (as routinely done), and a continuous low-dose ketamine infusion (0.25 mg per kilogram per hour) will be given until the permanent electrode is implanted on the same operated side, or in the event that unwanted side effects that can't be controlled appear. During surgery, monitoring of muscle activity (EMG) and brain activity (EEG) will be performed During the operation a short canola will be inserted through the meningeal opening and fixed to the surface of the cerebral cortex. Through the cannula A 10 mm deep microelectrode will be inserted, which will record electrical activity from the cerebral cortex for several minutes (up to 15 minutes). During the recording period the patient may be asked to perform a simple cognitive task using a computer or iPad. Following the recording the canola and the microelectrode will be removed and the canola will be inserted to the depth of the brain as part of the standard surgery and through it the microelectrode will be inserted into the brain target, and recording of electrical activity from the depths of the brain, as is customary will be performed. At the end of the ketamine phase, at the end of the electrophysiological monitoring required for navigation, prior to the electrical stimulation, when the electrode is placed at the bottom of the sub-thalamic nucleus, the patient will be shown for 60 seconds 10 images of objects (a single object in each image, different from the objects presented to him the day before) which he will asked to remember. At the same time on the screen will present electrical recordings from the depth of the brain (MER) by the brain electrode. In addition, the patient will be asked grade the anxiety level he is experiencing using the Visual Anxiety Scale (VAS) . On the day after surgery, the patient will be asked to recall which objects were presented to him the day before the operation and during the operation. Note that the two object lists will be from a database of objects used in functional day-to-day life (standard lists used for the CMT test - contextual memory test). In addition, the patient will be asked to answer a Visual Anxiety Scale (VAS) and the Iowa satisfaction score questionnaire detailing the patients overall overall experience, mood and feelings during surgery. These assessments will be performed by a neuropsychologist and using a validated questionnaire. Two weeks surgery, the patient will be presented with pictures of various objects and will be asked to recall which of them were presented before and during surgery. In addition the patient will be requested to fill grade his VAS anxiety scale and the IOWA questionnaire.

Tracking Information

NCT #
NCT04716296
Collaborators
Not Provided
Investigators
Principal Investigator: Idit O Tamir, MD Rabin Medical Center