Effectiveness and Reliability of Hypnosis in Stereotaxy

Parkinson Disease Clinical Trial

— ERST  

Official title:

Effectiveness and Reliability of Hypnosis in Stereotaxy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03074422
• Other study ID #: 2016-01843
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: July 30, 2020

Study information

• Verified date: October 2018
• Source: University Hospital, Geneva
• Contact: Marco Corniola
• Phone: 0795533770
• Email: marco.corniola[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dystonia
• Dystonia, Primary
• Dystonic Disorders
• Essential Tremor
• Parkinson Disease
• Tremor
• Tremor, Essential

Intervention

Procedure:
• Hypnosis
Hypnosis session performed by a board certified senior anesthesiologist during the frame fixation on the patient's head.

Locations

Country	Name	City	State
Switzerland	Geneva University Hospital	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (16)

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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. Review. — View Citation

Benabid AL, Chabardès 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. Review. — View 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. — View 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. — View 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. — View 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. Review. French. — View 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. French. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Watson R, Leslie K. Nerve blocks versus subcutaneous infiltration for stereotactic frame placement. Anesth Analg. 2001 Feb;92(2):424-7. — View 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on pain	To determine whether the hypnosis is effective in decreasing the pain perceived by the patient during the placement of the stereotactic frame on the patient's head.	2 years
Secondary	Effect on the stress perceived during the procedure	To measure the stress perceived during the procedure by submitting the patient to validated scores .	2 years
Secondary	Effect on the incidence of post-traumatic stress disorder	To evaluate the incidence of Post-traumatic Stress Disorder (PTSD), according to the DSM-IV criteria	2 years