Evaluation of the Interest of Hypno-relaxation During Somatosensory Evoked Potentials (HYPOT)

April 26, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Veronique MARCAUD, MD
  • Phone Number: +33 0144127242
  • Email: vmarcaud@hpsj.fr

Study Contact Backup

  • Name: Helene P BEAUSSIER, PharmD, PhD
  • Phone Number: +33 0144127038
  • Email: crc@hpsj.fr

Study Locations

  • France
      • Paris, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Somatosensory evoked potentials without hypnorelaxation

As part of this research, the patient must complete a pain scale and a Spielberger Stay-A anxiety self-assessment questionnaire before the PES examination.

Somatosensory evoked potentials are carried out according to the usual management.
Experimental: Somatosensory evoked potentials with hypnorelaxation
As part of this research, the patient must complete a pain scale and a Spielberger Stay-A anxiety self-assessment questionnaire before the PES examination. 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 suggestions and metaphors. The protocol is 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. The investigator, thanks to hypnosis, allows the development of a creative imagination which allows a modification of the relation to space and time.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of the somatosensory evoked potentials
Time Frame: one day
This correspond to the duration of the somatosensory evoked potentials exam in minuts, between the 2 groups.
one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of the somatosensory evoked potentials
Time Frame: one day
This outcome corresponds to the number of averages used to realize the somatosensory evoked potentials exam.
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2020

Primary Completion (Actual)

January 16, 2023

Study Completion (Actual)

April 6, 2023

Study Registration Dates

First Submitted

December 30, 2019

First Submitted That Met QC Criteria

January 2, 2020

First Posted (Actual)

January 6, 2020

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYPOT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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