Development of Stimulator Pneumatic for Realization of Evoked Potential Allodynic/Somatosensory (STIMEA)

Centre Hospitalier Universitaire de Saint Etienne

Status: Terminated

Conditions: Neuropathic Pain

Treatments: Other: no stimulation (control); Other: pneumatic stimulations no auditory masking; Other: pneumatic stimulations with audidory masking; Other: pneumatic stimulations(allodynic area); Other: pneumatic stimulations (healthy area)

Study type: Interventional

Funder types: Other

Identifiers

NCT02527590

2010-A00568-31 (Other Identifier)

1008057

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

patient with neuropathic pain with allodynia

Experimental group

Treatment:

Other: pneumatic stimulations (healthy area)

Other: no stimulation (control)

Other: pneumatic stimulations(allodynic area)

healthy volunteers

Experimental group

Treatment:

Other: pneumatic stimulations with audidory masking

Other: pneumatic stimulations no auditory masking

Other: no stimulation (control)