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

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.

Study Overview

• Status: Terminated
• Conditions: Neuropathic Pain
• Intervention / Treatment: Other: pneumatic stimulations(allodynic area); Other: pneumatic stimulations (healthy area); Other: no stimulation (control); Other: pneumatic stimulations no auditory masking; Other: pneumatic stimulations with audidory masking

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint Etienne, France, 42055
    • CHU de Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: healthy volunteers	Other: no stimulation (control); no stimulation (control condition): air jet directed beside the hand; Other: pneumatic stimulations no auditory masking; 2 series of pneumatic stimulations (air jet) on the hand (without feeling pain) for recording evoked potentials; 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.
Experimental: patient with neuropathic pain with allodynia	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: no stimulation (control); no stimulation (control condition): air jet directed beside the hand

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
latencies evoked potentials allodynic tires	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.	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Roland PEYRON, MD, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2011
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: August 11, 2015
• First Submitted That Met QC Criteria: August 17, 2015
• First Posted (Estimate): August 19, 2015

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 15, 2018
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: 1008057; 2010-A00568-31 (Other Identifier: AFSAPPS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO