Evaluation of the Interest of Hypno-relaxation During Somatosensory Evoked Potentials

Neuropathy;Peripheral Clinical Trial

— HYPOT  

Official title:

Evaluation of the Interest of Hypno-relaxation During Somatosensory Evoked Potentials

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04218448
• Other study ID #: HYPOT
• Status: Terminated
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: April 6, 2023

Study information

• Verified date: April 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Somatosensory evoked potentials corresponds to a neurophysiological exam that studies the functioning of the sensitivity pathways. It is often complementary to the imaging examination (MRI or scanner) and the electroneuromyogram which studies only the peripheral part of the sensory and motor pathways while the somatosensory evoked potentials are interested in their central and peripheral component.

The studied information are the potentials generated in the nervous system by the presentation of sensory stimulation. The examination makes it possible to study conduction times which will be defined as normal or pathological according to standards established on control subjects. Their indication is multiple: study of the repercussions of cervical osteoarthritis, specify the diagnosis of certain neuropathies, study of the conduction pathways at the medullary level in the event of trauma or inflammatory or other lesion.

In our study, the investigators will only be interested in the somatosensory evoked Potentials.

A study has shown that hypnotic suggestions to reduce the unpleasantness of pain triggered by thermal stimulation lead to a selective reduction of activity in the anterior cingulate cortex without modifying the activation of the somesthetic cortex.

Pain is, like all sensory stimulation, subject to the influences of attention, anticipation, mental imagery, previous conditioning. The fronto-cingular areas, activated by analgesics such as morphine, or by cortical stimulation are the same as those used by non-drug techniques such as hypnosis.

Therapeutic hypnosis is "a relational experience bringing into play physiological and psychological mechanisms allowing the individual to live better, reduce or eliminate an acute or chronic painful pathology" (Definition of Doctor Jean Marc Benhaiem).

The study of somatosensory evoked Potentials is a long examination (90 to 120 minutes), which can be uncomfortable for the patient (patient lying down, immobile and relaxed), not having to contract his muscles, especially if he is already painful due to his pathology or if it is difficult for him to remain motionless in the supine position. It is indeed necessary to average around 600 to 1000 responses (number of averages) to a small electrical simulation on each member studied.

The muscular contractions of an anxious and/or painful patient prolong the duration of the examination or even disturb the results, to the point of making it impossible to interpret the examination.

To our knowledge, hypnosis has already been used to improve muscle relaxation and reduce anxiety and pain during electromyograms, but hypnosis has never been used to improve the outcome of somatosensory evoked Potentials. Furthermore, if hypnosis modifies certain late cortical waves, it does not cause modification of the early waves and therefore does not disturb the results expected in our clinical practice.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: April 6, 2023
• Est. primary completion date: January 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient aged = 18 years

• Patient who was prescribed PES

• French speaking patient

• Patient affiliated to a social security scheme

• Patient having given oral, free, informed and express consent

Exclusion Criteria:

• Patient with severe pathologies of the peripheral nerve

• Patient under guardianship or curatorship

• Patient deprived of liberty

• Pregnant woman

• Patient denies

• Psychotic patient

Related Conditions & MeSH terms

• Neuropathy;Peripheral
• Peripheral Nervous System Diseases

Intervention

Other:
• Hypnorelaxation
Hypno-relaxation is induced by following VAKOG: external sensory identification, fixation of attention, bodily sensation, breathing, sensory perceptions, closing of the eyes. The work phase follows induction and allows deepening of the hypnotic trance. It corresponds to a metaphorical narrative associated with post-hypnotic suggestions and is fueled by the construction of adapted suggestions and metaphors, adapted to each patient. The investigator who remains present throughout the duration of the examination, maintains a hypnotic, empathetic, attentive attitude, and makes it possible to recover this material. Using the elements previously supplied by the patient, the investigator tells a story which allows the patient to focus his attention on something other than the performance of the somatosensory evoked potentials examination. The investigator, thanks to hypnosis, allows the development

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (9)

De Pascalis V, Magurano MR, Bellusci A. Pain perception, somatosensory event-related potentials and skin conductance responses to painful stimuli in high, mid, and low hypnotizable subjects: effects of differential pain reduction strategies. Pain. 1999 De — View Citation

Del Percio C, Triggiani AI, Marzano N, De Rosas M, Valenzano A, Petito A, Bellomo A, Soricelli A, Cibelli G, Babiloni C. Subjects' hypnotizability level affects somatosensory evoked potentials to non-painful and painful stimuli. Clin Neurophysiol. 2013 Jul;124(7):1448-55. doi: 10.1016/j.clinph.2013.02.008. Epub 2013 Apr 25. — View Citation

Faymonville ME, Laureys S, Degueldre C, DelFiore G, Luxen A, Franck G, Lamy M, Maquet P. Neural mechanisms of antinociceptive effects of hypnosis. Anesthesiology. 2000 May;92(5):1257-67. doi: 10.1097/00000542-200005000-00013. — View Citation

Fiorio M, Recchia S, Corra F, Tinazzi M. Behavioral and neurophysiological investigation of the influence of verbal suggestion on tactile perception. Neuroscience. 2014 Jan 31;258:332-9. doi: 10.1016/j.neuroscience.2013.11.033. Epub 2013 Nov 27. — View Citation

Lang EV, Benotsch EG, Fick LJ, Lutgendorf S, Berbaum ML, Berbaum KS, Logan H, Spiegel D. Adjunctive non-pharmacological analgesia for invasive medical procedures: a randomised trial. Lancet. 2000 Apr 29;355(9214):1486-90. doi: 10.1016/S0140-6736(00)02162- — View Citation

Rainville P, Duncan GH, Price DD, Carrier B, Bushnell MC. Pain affect encoded in human anterior cingulate but not somatosensory cortex. Science. 1997 Aug 15;277(5328):968-71. doi: 10.1126/science.277.5328.968. — View Citation

Slack D, Nelson L, Patterson D, Burns S, Hakimi K, Robinson L. The feasibility of hypnotic analgesia in ameliorating pain and anxiety among adults undergoing needle electromyography. Am J Phys Med Rehabil. 2009 Jan;88(1):21-9. doi: 10.1097/PHM.0b013e31818 — View Citation

Stoelb BL, Molton IR, Jensen MP, Patterson DR. THE EFFICACY OF HYPNOTIC ANALGESIA IN ADULTS: A REVIEW OF THE LITERATURE. Contemp Hypn. 2009 Mar 1;26(1):24-39. doi: 10.1002/ch.370. — View Citation

Vanhaudenhuyse A, Boveroux P, Boly M, Schnakers C, Bruno MA, Kirsch M, Demertzi A, Lamy M, Maquet P, Laureys S, Faymonville ME. [Hypnosis and pain perception]. Rev Med Liege. 2008 May-Jun;63(5-6):424-8. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of the somatosensory evoked potentials	This correspond to the duration of the somatosensory evoked potentials exam in minuts, between the 2 groups.	one day
Secondary	Quality of the somatosensory evoked potentials	This outcome corresponds to the number of averages used to realize the somatosensory evoked potentials exam.	one day