Development of Stimulator Pneumatic for Realization of Evoked Potential Allodynic/Somatosensory

Not Applicable

Terminated

• Conditions: Neuropathic Pain
• Interventions: Other: pneumatic stimulations(allodynic area); Other: pneumatic stimulations no auditory masking; Other: pneumatic stimulations (healthy area); Other: no stimulation (control); Other: pneumatic stimulations with audidory masking

• Registration Number: NCT02527590
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-19
• Status Verified: 2016-08
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2018-01-15
• Last Update Posted: 2018-01-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patient with neuropathic pain with allodynia	no stimulation (control)	-
patient with neuropathic pain with allodynia	pneumatic stimulations(allodynic area)	-
healthy volunteers	no stimulation (control)	-
healthy volunteers	pneumatic stimulations with audidory masking	-
patient with neuropathic pain with allodynia	pneumatic stimulations (healthy area)	-
healthy volunteers	pneumatic stimulations no auditory masking	-

Primary Outcome Measures

Name	Time	Method
composite outcomes : latencies and amplitudes of pneumatic evoked potential	Day 1	latencies (in ms) and peak-to-peak amplitudes (in μV) were measured on the electrode providing the response with the highest amplitude.

Secondary Outcome Measures

Name	Time	Method
latencies evoked potentials allodynic tires	Day 1	The latencies of allodynic evoked potentials (allodynic patients) and latencies of somesthetic evoked potentials (healthy volunteers). The mean of latencies somatosensory evoked potentials in healthy volunteers will be calculated with its confidence interval. Thus, for each patient allodynic if the latency of its response is not included in this confidence interval then his answer will be considered pathological.

Trial Locations

Locations (1)

Chu de Saint Etienne; 🇫🇷 Saint Etienne, France