Development of Stimulator Pneumatic for Realization of Evoked Potential Allodynic/Somatosensory (NCT02527590) | Clinical Trial Compass
TerminatedNot Applicable
Development of Stimulator Pneumatic for Realization of Evoked Potential Allodynic/Somatosensory
Stopped: low recruitment rate
France71 participantsStarted 2011-02
Plain-language summary
The stimuli used in the evoked potentials are electrical or laser. They are started and synchronized with the collection of the EEG by signals TTL (transistor-transistor logic). Investigators propose to validate a pneumatic stimulator delivering the compressed air sync with the EEG. It has two advantages over existing stimuli: Is capable of inducing in patients an allodynic response, excessive, painful, in response to a stimulation painless rarely obtained with laser or electrical stimuli. Therefore, the pneumatic stimulation is a means to study allodynic evoked potentials unknown to date.
It must be possible with a single stimulator to explore non-painful sensations and allodynic sensation , compare them with one device. The differences are the abnormal responses. This validation assumes evoked potential recording 1. somatosensory (low stimulation) then 2. allodynic (only in patients). The study therefore provides for the registration 100 potential for each of these two modalities in patients and only for the painless pneumatic modality in volunteers.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria of patients :
* Major Patient
* Patient affiliated or entitled to a social security scheme
* Patient with neuropathic pain authenticated by the neurologist, with the presence of allodynia.
* Patient has given its written consent to participate in the study
Exclusion Criteria of patients :
* Diseases affecting the nervous system,
* Diabetes,
* Patients who received chemotherapy
* Pregnant woman
* Nobody in emergencies
* A person unable to give consent
Inclusion Criteria of healthy volunteers :
* Major subject
* Subject affiliated or entitled to a social security scheme
* Subject has given its consent to participate in the study
Exclusion Criteria of healthy volunteers :
* Diseases affecting the nervous system,
* Diabetes,
* Patients who received chemotherapy
* Pregnant woman
* Nobody in emergencies
* A person unable to give consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
composite outcomes : latencies and amplitudes of pneumatic evoked potential
Timeframe: Day 1
Trial details
NCT IDNCT02527590
SponsorCentre Hospitalier Universitaire de Saint Etienne