Clinical trial NCT00355927: Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders.
Official title: Changes of the Neuronal Activity in the Subthalamic Nucleus Under Propofol Sedation During Stereotactic Electrode Implantation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Movement Disorders
Parkinson Disease
Parkinsonian Disorders
Dystonia
Tourette Syndrome
Keywords: Deep brain stimulation
Microelectrode recordings
Basal Ganglia
Sedation
Propofol
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-07-25
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to detect possible changes in the electrical activity of the Basal Ganglia related to sedation during deep brain stimulation surgery.

Detailed description: Deep Brain Stimulation is commonly used for the treatment of movement disorders. Electrode positioning is usually performed under local anesthesia in fully awake patients. The procedure is uncomfortable to the patients who have to remain motionless during the whole surgery. Previous reports of electrode positioning under general anesthesia was found to be less accurate. This result was probably due to the effect of the anesthetics on the electrical activity of the Basal Ganglia.

The purpose of this study is to detect possible changes in the electrical activity of the Basal Ganglia related to propofol sedation. Electrical activity of single neurons will be recorded before and after sedation.

Eligibility criteria: Inclusion Criteria:

* Candidate for Deep Brain Stimulation Surgery.
* Informed concent obtained.

Exclusion Criteria:

* Suspected difficult intubation (by history or physical examination).
* Allergy to Propofol, eggs or soy-beans.
* History of sleep apnea syndrome.

Primary outcomes:
measure: Changes in the electrical activity of neuron cells of the basal ganglia in the examined patients
timeFrame: Within 24 hours needed to analyse the data
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Dan Eimerl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Zvi Israel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Israel Z, Hassin-Baer S. Subthalamic stimulation for Parkinson's disease. Isr Med Assoc J. 2005 Jul;7(7):458-63.
citation: Maltete D, Navarro S, Welter ML, Roche S, Bonnet AM, Houeto JL, Mesnage V, Pidoux B, Dormont D, Cornu P, Agid Y. Subthalamic stimulation in Parkinson disease: with or without anesthesia? Arch Neurol. 2004 Mar;61(3):390-2. doi: 10.1001/archneur.61.3.390.
citation: Limousin P, Krack P, Pollak P, Benazzouz A, Ardouin C, Hoffmann D, Benabid AL. Electrical stimulation of the subthalamic nucleus in advanced Parkinson's disease. N Engl J Med. 1998 Oct 15;339(16):1105-11. doi: 10.1056/NEJM199810153391603.
citation: Benady A, Zadik S, Eimerl D, Heymann S, Bergman H, Israel Z, Raz A. Sedative drugs modulate the neuronal activity in the subthalamic nucleus of parkinsonian patients. Sci Rep. 2020 Sep 3;10(1):14536. doi: 10.1038/s41598-020-71358-3.
citation: Raz A, Eimerl D, Zaidel A, Bergman H, Israel Z. Propofol decreases neuronal population spiking activity in the subthalamic nucleus of Parkinsonian patients. Anesth Analg. 2010 Nov;111(5):1285-9. doi: 10.1213/ANE.0b013e3181f565f2. Epub 2010 Sep 14.