Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ketamine in Deep Brain Stimulation (DBS) Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04716296
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Idit tamit, Rabin Medical Center

Tracking Information
First Submitted Date  ICMJE October 9, 2020
First Posted Date  ICMJE January 20, 2021
Last Update Posted Date March 10, 2021
Actual Study Start Date  ICMJE January 1, 2021
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2021)
Electrophysiological recordings MER, Local field potentials and multiunit activity [ Time Frame: During surgery ]
Efficacy of Ketamine for use of the second stage of DBS surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2021)
  • Side effects from ketamine use [ Time Frame: During surgery ]
    Example : hypertension resulting following ketamine use.
  • The participants neurological status [ Time Frame: During surgery ]
  • Patients satisfaction levels measured using owa Satisfaction with Anesthesia Scale [ Time Frame: Up to two weeks postoperatively ]
    Overall participant satisfaction
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine in Deep Brain Stimulation (DBS) Surgery
Official Title  ICMJE Intraoperative Use of Ketamine for Awake Deep Brain Stimulation (DBS) Surgery Compared to Standard Procedure
Brief Summary

Deep brain stimulation (DBS) is a well-established and effective treatment for motor symptoms resulting from idiopathic Parkinson's disease (PD). During the DBS surgery , a brain electrode is implanted in the basal ganglia, which is involved in the pathophysiology of the disease. The surgery consists of three steps: 1. Opening the skin, drilling the skull bone and inserting a temporary electrode. 2. Recording electrical activity of the brain, electrical stimulation of the brain which guide the implantation of the electrode.3 Transferring wires and implanting a subcutaneous pacemaker battery in the chest area.

Today, standard treatment protocols consist undergoing the second stage (or first and second stage, depending on the treatment center protocol) of the surgery awake (under local anesthesia only). As systemic anesthetics affect cerebral electrical activity and prevent patient cooperation, they inhibit precise identification of the cerebral target under 'physiological navigation' guided by electrical recording and brain stimulation. As a result, the accuracy of electrode implantation decreases. However, undergoing surgery in an awake format often causes severe patient discomfort and anxiety necessitating shortening the length of surgery or aborting the surgery.

As such there is a need for establishing an alternative anesthesia protocol for DBS surgeries.

Ketamine is considered a unique anesthetic due to its hypnotic properties, analgesia, and possible amnesia. Standard doses of ketamine are currently used worldwide to treat patients with various injuries and brain diseases. Research from monkeys has shown that ketamine (in low dose) does not affect electrical brain activity used for physiological navigation.

The investigators therefore propose a prospective , randomized , blinded study to evaluate the utility of low dose of ketamine in the second stage of DBS surgeries for increasing patient satisfaction and cooperation without detracting from the accuracy of physiological navigation to the cerebral target.

This study will compare two treatment arms :

Treatment arm consisting of patients randomized to receive a low dose of ketamine for the second stage of DBS surgery.

Control arm consisting of patients randomized to receive sham control of saline during the second stage of DBS surgery.

Detailed Description
  1. 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.
  2. 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.
  3. 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.
  4. During surgery, monitoring of muscle activity (EMG) and brain activity (EEG) will be performed
  5. 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) .

  6. 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.

  7. 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 arm
Primary Purpose: Treatment
Condition  ICMJE Deep Brain Stimulation
Intervention  ICMJE
  • Drug: Ketamine
    Ketamine will be given for the second stage of the DBS surgery.
  • Drug: Saline
    Saline will be given for the second stage of the DBS surgery.
Study Arms  ICMJE
  • Experimental: Ketamine arm
    Treatment arm consisting of patients randomized to receive a low dose of ketamine for the second stage of DBS surgery.
    Intervention: Drug: Ketamine
  • Active Comparator: Control arm
    Control arm consisting of patients randomized to receive sham control of saline during the second stage of DBS surgery.
    Intervention: Drug: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 16, 2021)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged 18 and above
  • Patients with history of Parkinson's disease
  • Patients undergoing deep brain stimulation surgery on subthalamic nucleus from the neurology and the neurosurgery at Beilinson hospital
  • Patients with the ability to comply with the study requirements and undergoing Patients whom fulfill all above requirements will be approached for enrollment.

Exclusion Criteria:

  • Patients who can't cooperate and fulfill study requirements.
  • Patients who are at increased risk for performing study related tasks
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Idit Tamir, MD 055-6840465 iditta1@clalit.org.il
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04716296
Other Study ID Numbers  ICMJE 0328-20-RMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Idit tamit, Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Idit O Tamir, MD Rabin Medical Center
PRS Account Rabin Medical Center
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP