- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04189965
Traumatic Long-term Memory of Pain in Humans (TRAUMADOL)
Traumatic Long-term Memory of Pain - Pain Conditioning Study in Humans
Study Overview
Status
Conditions
Intervention / Treatment
- Other: Validation of virtual environment and auditive stimulation with virtual reality glasses (Pilot phase)
- Other: Electrical cutaneous stimulation and auditive stimulation (Principal Experimental phase)
- Other: Electrical cutaneous stimulation and auditive stimulation (Secondary Experimental phase)
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Luis GARCIA-LARREA, MD
- Phone Number: +33 4 72 35 78 88
- Email: luis-jose.garcia-larrea@chu-lyon.fr
Study Contact Backup
- Name: Maud FROT
- Phone Number: +33 4 72 35 78 88
- Email: maud.frot@univ-lyon1.fr
Study Locations
-
-
-
Bron, France, 69677
- Recruiting
- Hôpital Neurologique,
-
Contact:
- Luis GARCIA-LARREA, MD
- Phone Number: +33 4 72 35 78 88
- Email: luis-jose.garcia-larrea@chu-lyon.fr
-
Principal Investigator:
- Luis GARCIA-LARREA, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy subject
- Subject between 18 and 50 years old
- Subjects having given their written consent
- Subjects with health insurance
Exclusion Criteria:
- 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
- Heart issues
- Subjects under justice surveillance
- Subjects participating in another study which inclusion period overlaps with the one from this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Pilot group
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. |
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: Experimental group
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) |
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 subgroup
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) |
This phase is the same of the Principal Experimental phase except for the EEG that will not be performed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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)
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of short-term memory of an environment according to whether it is associated with a painful stimulation or not
Time Frame: day 2
|
This outcome is evaluated by combined tests:
|
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
|
This outcome is evaluated by combined tests:
|
day 30
|
Assessment subject capacity to create false memory of environment according to the associated stimulation (pain or no pain)
Time Frame: day 2
|
Questionnaire will be conducted on environment (presence or absence of different objects) to assess false memories
|
day 2
|
Assessment subject capacity to create false memory of environment according to the associated stimulation (pain or no pain)
Time Frame: day 30
|
Questionnaire will be conducted on environment (presence or absence of different objects) to assess false memories
|
day 30
|
Eye-tracking measurements, to assess the exploration of different contexts according to their nature
Time Frame: Day 1
|
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
|
Day 1
|
Assessment of the total duration needed for total extinction
Time Frame: 30 minutes
|
The amount of time needed for vegetative reactions to go back to baseline will be assessed during the extinction phase
|
30 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 69HCL19_0413
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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