Clinical trial NCT03074422: Effectiveness and Reliability of Hypnosis in Stereotaxy
Official title: Effectiveness and Reliability of Hypnosis in Stereotaxy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Tremor, Essential
Dystonia, Primary
Keywords: Functional neurosurgery
Pain management
Hypnosis
Stereotaxy
Parkinson disease
Essential tremor
Dystonia
Invasive monitoring of epilepsy
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patients will be randomly attributed to either the "hypnosis" group or the control group, by a randomization process. The investigators plan to allocate patients in two groups; in the first group, patients will undergo hypnosis during the fixation of the stereotactic frame. In the second group (control group), the frame disposal will be performed following the actual standard of care, with a LA performed during the procedure.
Primary purpose: TREATMENT

Brief summary: In certain neurosurgical procedures, the use of a stereotaxic frame is required. It is then possible to set a precise target (depending of the type of the surgery) to be reached by the surgeon. The fixation of the stereotactic frame on the awake patient's head is done under local anesthesia by screwing the frame directly into the skull. This procedure is reported as "painful" to "extremely painful" by patients. The objective of this study is to determine whether the hypnosis is effective in decreasing the pain perceived by the patient during the disposal of the stereotactic frame.

Detailed description: The role of hypnosis (no sedative drug administered) and hypnosedative procedures (hypnosis with the adjunct of a sedative drug) during surgical procedures has been largely discussed during the past 10 years, and those techniques are now widely practiced in the surgical field, for example during thyroidectomies. In neurosurgery specifically, the successful use of hypnosedation during awake neurosurgical procedures has been recently reported, with a positive feedback from the patients, together with good results regarding extent of resection, in the case of brain lesions located in eloquent areas.

Since 1990, many research groups identified the existence of hypnosis-related phenomena and their influence on the pain signal perception. These authors show that there is a modulation of the anterior cingulate area activity together with modified interconnectivity with other critical regions involved in nociception. In this context, the potential of hypnosis in pain modulation and, more extensively, patient management in surgical anesthetics was established.

In various neurosurgical procedures, the use of a stereotactic frame is required; by using coordinates (x, y and z), which are computed and reported on the frame before the intervention, it is possible to set a precise target (dependent on the type of surgery) to be reached by the surgeon. For instance, during a Deep Brain Stimulation (DBS) performed in a patient suffering from Parkinson's disease (PD), the electrodes are introduced into the brain, deep down to the sub-thalamic nuclei (STN), which are situated in a very little area located in the upper brainstem. The mounting of the stereotactic frame on the patient's head is performed under local anesthesia (LA), as the patient is awake during the mounting procedure and later on during the surgical intervention. This mounting is done by screwing the device directly into the patient's skull, through the skin. This moment is reported as "painful" to "extremely painful" by patients, and most of them confess to keep a very unpleasant memory of the event, even several years after the procedure and despite the fact that the surgery had a positive effect on their functional outcome.

As exposed above, there is still room for improvement in the management of pain and comfort of patients undergoing functional procedures in neurosurgery, especially during the placement of the stereotactic frame. To our opinion, hypnosis could represent a serious therapy against pain and anxiety generated by the frame fixation, especially those whom facial expressions and feelings might be altered by their pathology (i.e. Parkinson's disease). In fact, this technique has already been abundantly reported as an important adjuvant to the management of pain and comfort during surgeries such as thyroidectomies) and resection of brain tumors.

The main objective of this study is to determine whether hypnosis is effective in decreasing the pain perceived by the patient during the placement of the stereotactic frame on the patient's head.

The secondary aims of this study are: 1) to measure the stress perceived during the procedure by submitting the patient to validated scores and 2) to evaluate the incidence of Post-traumatic Stress Disorder (PTSD), according to the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing a stereotactic procedure as listed previously
* Patients ≥ 18 y.o.

Exclusion Criteria:

* Patients \< 18 y.o.
* Patients unable to take decisions by their own
* Patients undergoing deep brain stimulation for obsessive-compulsive disease treatment
* Patients refusing to participate to the study
* Pregnancy
* Invasive monitoring of epilepsy
* Psychiatric comorbidity

Primary outcomes:
measure: Effect on pain
timeFrame: 2 years
Secondary outcomes:
measure: Effect on the stress perceived during the procedure
timeFrame: 2 years
measure: Effect on the incidence of post-traumatic stress disorder
timeFrame: 2 years
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospital
Study officials:
affiliation: University Hospital, Geneva
name: Marco Corniola
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang DD, Lau D, Rolston JD, Englot DJ, Sneed PK, McDermott MW. Pain experience using conventional versus angled anterior posts during stereotactic head frame placement for radiosurgery. J Clin Neurosci. 2014 Sep;21(9):1538-42. doi: 10.1016/j.jocn.2014.02.009. Epub 2014 May 6.
citation: Rahman M, Murad GJ, Mocco J. Early history of the stereotactic apparatus in neurosurgery. Neurosurg Focus. 2009 Sep;27(3):E12. doi: 10.3171/2009.7.FOCUS09118.
citation: Murata J, Sawamura Y, Kitagawa M, Saito H, Kikuchi S, Tashiro K. [Minimally invasive stereotactic functional surgery using an intravenous anesthetic propofol and applying Image Fusion and AtlasPlan]. No To Shinkei. 2001 May;53(5):457-62. Japanese.
citation: Venkatraghavan L, Manninen P, Mak P, Lukitto K, Hodaie M, Lozano A. Anesthesia for functional neurosurgery: review of complications. J Neurosurg Anesthesiol. 2006 Jan;18(1):64-7. doi: 10.1097/01.ana.0000181285.71597.e8.
citation: Stokes MA, Soriano SG, Tarbell NJ, Loeffler JS, Alexander E 3rd, Black PM, Rockoff MA. Anesthesia for stereotactic radiosurgery in children. J Neurosurg Anesthesiol. 1995 Apr;7(2):100-8. doi: 10.1097/00008506-199504000-00005.
citation: Benabid AL, Chabardes S, Mitrofanis J, Pollak P. Deep brain stimulation of the subthalamic nucleus for the treatment of Parkinson's disease. Lancet Neurol. 2009 Jan;8(1):67-81. doi: 10.1016/S1474-4422(08)70291-6.
citation: Benabid AL, Chabardes S, Seigneuret E, Fraix V, Krack P, Pollak P, Xia R, Wallace B, Sauter F. Surgical therapy for Parkinson's disease. J Neural Transm Suppl. 2006;(70):383-92. doi: 10.1007/978-3-211-45295-0_58.
citation: Chevrier E, Fraix V, Krack P, Chabardes S, Benabid AL, Pollak P. Is there a role for physiotherapy during deep brain stimulation surgery in patients with Parkinson's disease? Eur J Neurol. 2006 May;13(5):496-8. doi: 10.1111/j.1468-1331.2006.01298.x.
citation: Fraix V, Pollak P, Chabardes S, Ardouin C, Koudsie A, Benazzouz A, Krack P, Batir A, Le Bas JF, Benabid AL. [Deep brain stimulation]. Rev Neurol (Paris). 2004 May;160(5 Pt 1):511-21. doi: 10.1016/s0035-3787(04)70980-7. French.
citation: Benabid AL, Pollak P, Hommel M, Gaio JM, de Rougemont J, Perret J. [Treatment of Parkinson tremor by chronic stimulation of the ventral intermediate nucleus of the thalamus]. Rev Neurol (Paris). 1989;145(4):320-3. French.
citation: Cojan Y, Waber L, Schwartz S, Rossier L, Forster A, Vuilleumier P. The brain under self-control: modulation of inhibitory and monitoring cortical networks during hypnotic paralysis. Neuron. 2009 Jun 25;62(6):862-75. doi: 10.1016/j.neuron.2009.05.021.
citation: Zemmoura I, Fournier E, El-Hage W, Jolly V, Destrieux C, Velut S. Hypnosis for Awake Surgery of Low-grade Gliomas: Description of the Method and Psychological Assessment. Neurosurgery. 2016 Jan;78(1):53-61. doi: 10.1227/NEU.0000000000000993.
citation: Tykocki T, Kornakiewicz A, Mandat T, Nauman P. Pain perception in patients with Parkinson's disease. J Clin Neurosci. 2013 May;20(5):663-6. doi: 10.1016/j.jocn.2012.05.043. Epub 2013 Feb 26.
citation: Watson R, Leslie K. Nerve blocks versus subcutaneous infiltration for stereotactic frame placement. Anesth Analg. 2001 Feb;92(2):424-7. doi: 10.1097/00000539-200102000-00028.
citation: Bellinghausen L, Collange J, Botella M, Emery JL, Albert E. [Factorial validation of the French scale for perceived stress in the workplace]. Sante Publique. 2009 Jul-Aug;21(4):365-73. French.
citation: Jehel L, Brunet A, Paterniti S, Guelfi JD. [Validation of the Peritraumatic Distress Inventory's French translation]. Can J Psychiatry. 2005 Jan;50(1):67-71. doi: 10.1177/070674370505000112. French.