Deep Brain StimulationNCT04716296
Ketamine in Deep Brain Stimulation (DBS) Surgery
A study testing Ketamine and Saline in people with Deep Brain Stimulation, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Deep Brain Stimulation
- What is being tested?
- Ketamine and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who can't cooperate and fulfill study requirements.
- Patients who are at increased risk for performing study related tasks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Use of Ketamine for Awake Deep Brain Stimulation (DBS) Surgery Compared to Standard Procedure
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.
Read more
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.
Read the detailed 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 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.
- Conditions
- Deep Brain Stimulation
- Being tested
- Ketamine, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Ketamine will be given for the second stage of the DBS surgery.
SalineDrug
Saline will be given for the second stage of the DBS surgery.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine arm | Experimental | Treatment arm consisting of patients randomized to receive a low dose of ketamine for the second stage of DBS surgery. Receives: Drug: Ketamine |
| Control arm | Active comparator | Control arm consisting of patients randomized to receive sham control of saline during the second stage of DBS surgery. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrophysiological recordings MER, Local field potentials and multiunit activity
Efficacy of Ketamine for use of the second stage of DBS surgery
Measured: During surgery
Secondary outcomes (3)
Side effects from ketamine use
Example : hypertension resulting following ketamine use.
Measured: During surgery
The participants neurological status
Participants' neurological status
Measured: During surgery
Patients satisfaction levels measured using owa Satisfaction with Anesthesia Scale
Overall participant satisfaction
Measured: Up to two weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start1 Jan 2021
- Primary completion15 Sep 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Brain StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Idit tamit, Rabin Medical Center
- Investigators
- Idit O Tamir, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716296
- Sponsor's protocol ID
- 0328-20-RMC
- Status last verified
- Mar 2023
- First submitted
- 9 Oct 2020
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Use of Ketamine for Awake Deep Brain Stimulation (DBS) Surgery Compared to Standard Procedure
- ClinicalTrials.gov ID
- NCT04716296
- Acronym / sponsor ID
- 0328-20-RMC
- Conditions
- Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine arm | Experimental | Drug: KetamineTreatment arm consisting of patients randomized to receive a low dose of ketamine for the second stage of DBS surgery. |
| Control arm | Active comparator | Drug: SalineControl arm consisting of patients randomized to receive sham control of saline during the second stage of DBS surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who can't cooperate and fulfill study requirements.
- Patients who are at increased risk for performing study related tasks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineKetamine will be given for the second stage of the DBS surgery. | Drug | Ketamine arm |
| SalineSaline will be given for the second stage of the DBS surgery. | Drug | Control arm |
Primary outcome
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
3 secondary outcomes
Side effects from ketamine use
Time frame: During surgery
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Idit O Tamir, MD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine and Saline in people with Deep Brain Stimulation, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrophysiological recordings MER, Local field potentials and multiunit activity (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.