PainTRAUMADOLNCT04189965
Traumatic Long-term Memory of Pain in Humans
A study testing Validation of virtual environment and auditive stimulation with virtual reality glasses (Pilot phase), Electrical cutaneous stimulation and auditive stimulation (Principal Experimental phase) and Electrical cutaneous stimulation and auditive stimulation (Secondary Experimental phase) in people with Pain and Traumatic Memory, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Few studies have focused on understanding the mechanisms underlying pain memory in humans. Thus, this project aims to investigate the link between pain memorisation and memorisation of the associated context by addressing the issue of pain conditioning. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Traumatic Memory
- What is being tested?
- Validation of virtual environment and auditive stimulation with virtual reality glasses (Pilot phase), Electrical cutaneous stimulation and auditive stimulation (Principal Experimental phase) and Electrical cutaneous stimulation and auditive stimulation (Secondary Experimental phase)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2021to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subject
- Subject between 18 and 50 years old
- Subjects having given their written consent
- Subjects with health insurance
Who cannot join
- Prior addiction to drugs
- Prior neurological issues
- Chronic pain (neuropathic or non-neuropathic)
- Pregnant/breast-feeding women
- Absence of efficient contraception method for the duration of the study (1 month) for participants of procreation age (no inclusion limitation for male participants of procreation age)
- Subjects under chronic analgesic treatment or having taken an analgesic treatment in the 24 h preceding the experiment
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- Heart issues
- Subjects under justice surveillance
- Subjects participating in another study which inclusion period overlaps with the one from this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Neurologique,
Bron, 69677
Luis GARCIA-LARREA, MD, 4 72 35 78 88 ext. +33, luis-jose.garcia-larrea@chu-lyon.fr
Luis GARCIA-LARREA, MD
About this study
Official title: Traumatic Long-term Memory of Pain - Pain Conditioning Study in Humans
Few studies have focused on understanding the mechanisms underlying pain memory in humans. Thus, this project aims to investigate the link between pain memorisation and memorisation of the associated context by addressing the issue of pain conditioning. The study is composed of two successive parts: one pilot then one experimental. The goal is to understand pain memorisation processes by analysing the parallel between pain memorisation and memorisation of a traumatic event. By using immersive virtual reality, investigators aim to show that contextual pain conditioning is associated with : 1- a specific neural networks; 2- a reactivation of vegetative and behavioural reactions related to pain as well as electro-physiological markers when re-exposure to the specific pain-conditioning-context; 3- an implicit hypermnesia of the pain-associated context and a struggle to extinguish conditioning; 4- a favoured elaboration of false memories of the contextual pain. The emitted hypothesis suggests that a cortical and behavioural mnemonic trace is created during encoding of pain in association with its context, and that the latter can reactivate although the pain itself has disappeared. This implicit cortical mnemonic trace, evoked by the simple pain-associated context, could explain the notion of pain print persisting at long-term in patients suffering from chronic pain.
- Conditions
- Pain, Traumatic Memory
- Being tested
- Validation of virtual environment and auditive stimulation with virtual reality glasses (Pilot phase), Electrical cutaneous stimulation and auditive stimulation (Principal Experimental phase), Electrical cutaneous stimulation and auditive stimulation (Secondary Experimental phase)
- Keywords
- Pain, Traumatic Long-term Memory
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation of virtual environment and auditive stimulation with virtual reality glasses (Pilot phase)Other
The goal of this phase is the development of the experimental protocol in virtual reality. Virtual environment will be checked and auditive stimulation will be graduated.
Electrical cutaneous stimulation and auditive stimulation (Principal Experimental phase)Other
This phase is the principal step of the study: during moving in virtual environment, electrical stimulation on one hand and auditive stimulation will be applied. EEG, ECG and skin conductance will be measured during conditioning phase and extinction phase (day 1, 30 minutes each phase). Behavioral measures will be done throughout the 3 sessions (day 1, day 2 and day 30)
Electrical cutaneous stimulation and auditive stimulation (Secondary Experimental phase)Other
This phase is the same of the Principal Experimental phase except for the EEG that will not be performed.
| Study group | Role | What they receive |
|---|---|---|
| Pilot group | Other | Subjects are volunteers of 18 to 50 years of age that have given consent and that are affiliated to a social security. Overall, subjects must be in good health (no chronic pain, neuropathy or cardiac/respiratory issues etc.) and (for women) non-pregnant.
The subject will be seated in an armchair. He will be asked to explore the virtual environment using virtual reality glasses to validate it.
The subject will also have headphones and different shouts or noises will be broadcast and he will have to rate the level of dislike of each sound stimulation. Receives: Other: Validation of virtual environment and auditive stimulation with virtual reality glasses (Pilot phase) |
| Experimental group | Other | Subjects are volunteers of 18 to 50 years of age that have given consent and that are affiliated to a social security. Overall, subjects must be in good health (no chronic pain, neuropathy or cardiac/respiratory issues etc.) and (for women) non-pregnant.
The subject will be seated in an armchair. He will be asked to explore the virtual environment using virtual reality glasses. He will also have headphones and different shouts or noises will be broadcast and an electric stimulation glove to study in humans the mechanisms of long-term memory of pain by exploring the parallel between memory of pain and memory of a traumatic event.
3 sessions of stimulation will be done (D0, D2 and D30) Receives: Other: Electrical cutaneous stimulation and auditive stimulation (Principal Experimental phase) |
| Experimental subgroup | Other | Subjects are volunteers of 18 to 50 years of age that have given consent and that are affiliated to a social security. Overall, subjects must be in good health (no chronic pain, neuropathy or cardiac/respiratory issues etc.) and (for women) non-pregnant.
The subject will be seated in an armchair. He will be asked to explore the virtual environment using virtual reality glasses. He will also have headphones and different shouts or noises will be broadcast and an electric stimulation glove to study in humans the mechanisms of long-term memory of pain by exploring the parallel between memory of pain and memory of a traumatic event.
3 sessions of stimulation will be done (D0, D2 and D30) Receives: Other: Electrical cutaneous stimulation and auditive stimulation (Secondary Experimental phase) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of electrophysiological (EEG) changes during a pain conditioning set up and its extinction
The EEG will be done throughout the conditioning phase and the extinction phase (30 minutes each)conducted during the first session of the experiment (Day 1)
Measured: day 1
Measurement of vegetative (electrodermal, electrocardiac) changes during a pain conditioning set up and its extinction
The cutaneous response and electro-cardiographic activity will be done throughout the conditioning phase and the extinction phase (30 minutes each)conducted during the first session of the experiment (Day 1)
Measured: day 1
Secondary outcomes (6)
Assessment of short-term memory of an environment according to whether it is associated with a painful stimulation or not
This outcome is evaluated by combined tests:
- Free recall test: the subjects will have to quote a maximum of memorized objects during the conditioning phase
- Recognition test: the objects present in the environment as well as objects not present in the environment will be presented randomly on a screen. Subjects should indicate whether the object in question was present in the environment or not.
Measured: day 2
Assessment of long-term memory of an environment according to whether it is associated with a painful stimulation or not
This outcome is evaluated by combined tests:
- Free recall test: the subjects will have to quote a maximum of memorized objects during the conditioning phase
- Recognition test: the objects present in the environment as well as objects not present in the environment will be presented randomly on a screen. Subjects should indicate whether the object in question was present in the environment or not.
Measured: day 30
Assessment subject capacity to create false memory of environment according to the associated stimulation (pain or no pain)
Questionnaire will be conducted on environment (presence or absence of different objects) to assess false memories
Measured: day 2
Assessment subject capacity to create false memory of environment according to the associated stimulation (pain or no pain)
Questionnaire will be conducted on environment (presence or absence of different objects) to assess false memories
Measured: day 30
Eye-tracking measurements, to assess the exploration of different contexts according to their nature
An Eye-tracking system will be included in the Virtual Reality glasses (used during conditioning and extinction) to assess eye-movement during exploration of the environment
Measured: Day 1
Assessment of the total duration needed for total extinction
The amount of time needed for vegetative reactions to go back to baseline will be assessed during the extinction phase
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start11 Jan 2021
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189965
- Sponsor's protocol ID
- 69HCL19_0413
- Acronym
- TRAUMADOL
- Status last verified
- Aug 2023
- First submitted
- 22 Nov 2019
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traumatic Long-term Memory of Pain - Pain Conditioning Study in Humans
- ClinicalTrials.gov ID
- NCT04189965
- Acronym / sponsor ID
- TRAUMADOL / 69HCL19_0413
- Conditions
- Pain, Traumatic Memory
- Keywords
- Pain, Traumatic Long-term Memory
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 9 Dec 2019 (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.
Few studies have focused on understanding the mechanisms underlying pain memory in humans. Thus, this project aims to investigate the link between pain memorisation and memorisation of the associated context by addressing the issue of pain conditioning. The study is composed of two successive parts: one pilot then one experimental. The goal is to understand pain memorisation processes by analysing the parallel between pain memorisation and memorisation of a traumatic event. By using immersive virtual reality, investigators aim to show that contextual pain conditioning is associated with : 1- a specific neural networks; 2- a reactivation of vegetative and behavioural reactions related to pain as well as electro-physiological markers when re-exposure to the specific pain-conditioning-context; 3- an implicit hypermnesia of the pain-associated context and a struggle to extinguish conditioning; 4- a favoured elaboration of false memories of the contextual pain. The emitted hypothesis suggests that a cortical and behavioural mnemonic trace is created during encoding of pain in association with its context, and that the latter can reactivate although the pain itself has disappeared. This implicit cortical mnemonic trace, evoked by the simple pain-associated context, could explain the notion of pain print persisting at long-term in patients suffering from chronic pain.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pilot group | Other | Other: Validation of virtual environment and auditive stimulation with virtual reality glasses (Pilot phase)Subjects are volunteers of 18 to 50 years of age that have given consent and that are affiliated to a social security. Overall, subjects must be in good health (no chronic pain, neuropathy or cardiac/respiratory issues etc.) and (for women) non-pregnant. The subject will be seated in an armchair. He will be asked to explore the virtual environment using virtual reality glasses to validate it. The subject will also have headphones and different shouts or noises will be broadcast and he will have to rate the level of dislike of each sound stimulation. |
| Experimental group | Other | Other: Electrical cutaneous stimulation and auditive stimulation (Principal Experimental phase)Subjects are volunteers of 18 to 50 years of age that have given consent and that are affiliated to a social security. Overall, subjects must be in good health (no chronic pain, neuropathy or cardiac/respiratory issues etc.) and (for women) non-pregnant. The subject will be seated in an armchair. He will be asked to explore the virtual environment using virtual reality glasses. He will also have headphones and different shouts or noises will be broadcast and an electric stimulation glove to study in humans the mechanisms of long-term memory of pain by exploring the parallel between memory of pain and memory of a traumatic event. 3 sessions of stimulation will be done (D0, D2 and D30) |
| Experimental subgroup | Other | Other: Electrical cutaneous stimulation and auditive stimulation (Secondary Experimental phase)Subjects are volunteers of 18 to 50 years of age that have given consent and that are affiliated to a social security. Overall, subjects must be in good health (no chronic pain, neuropathy or cardiac/respiratory issues etc.) and (for women) non-pregnant. The subject will be seated in an armchair. He will be asked to explore the virtual environment using virtual reality glasses. He will also have headphones and different shouts or noises will be broadcast and an electric stimulation glove to study in humans the mechanisms of long-term memory of pain by exploring the parallel between memory of pain and memory of a traumatic event. 3 sessions of stimulation will be done (D0, D2 and D30) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subject
- Subject between 18 and 50 years old
- Subjects having given their written consent
- Subjects with health insurance
Key exclusion criteria (9 listed)
- Prior addiction to drugs
- Prior neurological issues
- Chronic pain (neuropathic or non-neuropathic)
- Pregnant/breast-feeding women
- Absence of efficient contraception method for the duration of the study (1 month) for participants of procreation age (no inclusion limitation for male participants of procreation age)
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 |
|---|---|---|
| Validation of virtual environment and auditive stimulation with virtual reality glasses (Pilot phase)The goal of this phase is the development of the experimental protocol in virtual reality. Virtual environment will be checked and auditive stimulation will be graduated. | Other | Pilot group |
| Electrical cutaneous stimulation and auditive stimulation (Principal Experimental phase)This phase is the principal step of the study: during moving in virtual environment, electrical stimulation on one hand and auditive stimulation will be applied. EEG, ECG and skin conductance will be measured during conditioning phase and extinction phase (day 1, 30 minutes each phase). Behavioral measures will be done throughout the 3 sessions (day 1, day 2 and day 30) | Other | Experimental group |
| Electrical cutaneous stimulation and auditive stimulation (Secondary Experimental phase)This phase is the same of the Principal Experimental phase except for the EEG that will not be performed. | Other | Experimental subgroup |
Primary outcome
Measurement of electrophysiological (EEG) changes during a pain conditioning set up and its extinction
Time frame: day 1
The EEG will be done throughout the conditioning phase and the extinction phase (30 minutes each)conducted during the first session of the experiment (Day 1)
Measurement of vegetative (electrodermal, electrocardiac) changes during a pain conditioning set up and its extinction
Time frame: day 1
The cutaneous response and electro-cardiographic activity will be done throughout the conditioning phase and the extinction phase (30 minutes each)conducted during the first session of the experiment (Day 1)
6 secondary outcomes
Assessment of short-term memory of an environment according to whether it is associated with a painful stimulation or not
Time frame: day 2
Assessment of long-term memory of an environment according to whether it is associated with a painful stimulation or not
Time frame: day 30
Assessment subject capacity to create false memory of environment according to the associated stimulation (pain or no pain)
Time frame: day 2
Assessment subject capacity to create false memory of environment according to the associated stimulation (pain or no pain)
Time frame: day 30
Eye-tracking measurements, to assess the exploration of different contexts according to their nature
Time frame: Day 1
Assessment of the total duration needed for total extinction
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Validation of virtual environment and auditive stimulation with virtual reality glasses (Pilot phase), Electrical cutaneous stimulation and auditive stimulation (Principal Experimental phase) and Electrical cutaneous stimulation and auditive stimulation (Secondary Experimental phase) in people with Pain and Traumatic Memory, run by Hospices Civils de Lyon 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 8 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis GARCIA-LARREA, MD (4 72 35 78 88 ext. +33, luis-jose.garcia-larrea@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of electrophysiological (EEG) changes during a pain conditioning set up and its extinction (time frame: day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2023.