Neuropathy;PeripheralHYPOTNCT04218448
Evaluation of the Interest of Hypno-relaxation During Somatosensory Evoked Potentials
A study testing Hypnorelaxation in people with Neuropathy;Peripheral, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathy;Peripheral
- What is being tested?
- Hypnorelaxation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2020to 6 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient with severe pathologies of the peripheral nerve
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Pregnant woman
- Patient denies
- Psychotic patient
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Neuropathy;Peripheral
- Being tested
- Hypnorelaxation
- Medical subject headings
- Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnorelaxationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Somatosensory evoked potentials without hypnorelaxation | No intervention | 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. |
| Somatosensory evoked potentials with hypnorelaxation | Experimental | 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. Receives: Other: Hypnorelaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of the somatosensory evoked potentials
This correspond to the duration of the somatosensory evoked potentials exam in minuts, between the 2 groups.
Measured: one day
Secondary outcomes (1)
Quality of the somatosensory evoked potentials
This outcome corresponds to the number of averages used to realize the somatosensory evoked potentials exam.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start13 Jan 2020
- Primary completion16 Jan 2023
- Study completion6 Apr 2023
Why it stopped: PI's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Neuropathy;PeripheralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronique MARCAUD, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218448
- Sponsor's protocol ID
- HYPOT
- Acronym
- HYPOT
- Status last verified
- Apr 2023
- First submitted
- 30 Dec 2019
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23623560Fiorio 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.
PubMed 24291728Rainville 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.
PubMed 9252330Faymonville 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.
PubMed 10781270Lang 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)02162-0.
PubMed 10801169Stoelb 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.
PubMed 20161034Vanhaudenhuyse 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.
PubMed 18669215Slack 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.0b013e31818e00bd.
PubMed 18971768De 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 Dec;83(3):499-508. doi: 10.1016/S0304-3959(99)00157-8.
PubMed 10568858
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Interest of Hypno-relaxation During Somatosensory Evoked Potentials
- ClinicalTrials.gov ID
- NCT04218448
- Acronym / sponsor ID
- HYPOT / HYPOT
- Conditions
- Neuropathy;Peripheral
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI's decision
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Somatosensory evoked potentials without hypnorelaxation | No intervention | –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. |
| Somatosensory evoked potentials with hypnorelaxation | Experimental | Other: HypnorelaxationAs 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Patient with severe pathologies of the peripheral nerve
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Pregnant woman
- Patient denies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypnorelaxationHypno-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 | Other | Somatosensory evoked potentials with hypnorelaxation |
Primary outcome
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.
1 secondary outcome
Quality of the somatosensory evoked potentials
Time frame: one day
Results and safety
The study was stopped early (reason given: PI's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Background: PubMed 23623560Del 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.
- Results publication: PubMed 24291728Fiorio 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.
- Results publication: PubMed 9252330Rainville 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.
- Results publication: PubMed 10781270Faymonville 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.
- Results publication: PubMed 10801169Lang 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)02162-0.
- Results publication: PubMed 20161034Stoelb 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.
- Results publication: PubMed 18669215Vanhaudenhuyse 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.
- Results publication: PubMed 18971768Slack 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.0b013e31818e00bd.
- Results publication: PubMed 10568858De 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 Dec;83(3):499-508. doi: 10.1016/S0304-3959(99)00157-8.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronique MARCAUD, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnorelaxation in people with Neuropathy;Peripheral, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI's decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of the somatosensory evoked potentials (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04218448, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.