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

NCT02527590 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2018-01-17

No results posted yet for this study

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.

Conditions

  • Neuropathic Pain

Interventions

OTHER

pneumatic stimulations(allodynic area)

2 series of 20 pneumatic stimulations (air jet) on a allodynic area for recording evoked potentials

OTHER

pneumatic stimulations (healthy area)

2 series of 20 pneumatic stimulation on a healthy area (either contralateral or above or below allodynic area) will no pain triggering for recording evoked potentials

OTHER

pneumatic stimulations no auditory masking

2 series of pneumatic stimulations (air jet) on the hand (without feeling pain) for recording evoked potentials

OTHER

no stimulation (control)

no stimulation (control condition): air jet directed beside the hand

OTHER

pneumatic stimulations with audidory masking

2 series of 20 pneumatic stimulations (air jet) on the hand (without feeling pain) with auditory helmet that totally masked the air jet noise.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Roland PEYRON, MD · Centre Hospitalier Universitaire de Saint Etienne

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02527590 on ClinicalTrials.gov