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

Primary Purpose

Neuropathic Pain

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
pneumatic stimulations(allodynic area)
pneumatic stimulations (healthy area)
pneumatic stimulations no auditory masking
no stimulation (control)
pneumatic stimulations with audidory masking
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neuropathic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chu de Saint Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

patient with neuropathic pain with allodynia

healthy volunteers

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 11, 2015
Last Updated
January 15, 2018
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT02527590
Brief Title
Development of Stimulator Pneumatic for Realization of Evoked Potential Allodynic/Somatosensory
Acronym
STIMEA
Official Title
Development of Stimulator Pneumatic for Realization of Evoked Potential Allodynic/Somatosensory
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
low recruitment rate
Study Start Date
February 2011 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patient with neuropathic pain with allodynia
Arm Type
Experimental
Arm Title
healthy volunteers
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
pneumatic stimulations(allodynic area)
Intervention Description
2 series of 20 pneumatic stimulations (air jet) on a allodynic area for recording evoked potentials
Intervention Type
Other
Intervention Name(s)
pneumatic stimulations (healthy area)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
pneumatic stimulations no auditory masking
Intervention Description
2 series of pneumatic stimulations (air jet) on the hand (without feeling pain) for recording evoked potentials
Intervention Type
Other
Intervention Name(s)
no stimulation (control)
Intervention Description
no stimulation (control condition): air jet directed beside the hand
Intervention Type
Other
Intervention Name(s)
pneumatic stimulations with audidory masking
Intervention Description
2 series of 20 pneumatic stimulations (air jet) on the hand (without feeling pain) with auditory helmet that totally masked the air jet noise.
Primary Outcome Measure Information:
Title
composite outcomes : latencies and amplitudes of pneumatic evoked potential
Description
latencies (in ms) and peak-to-peak amplitudes (in μV) were measured on the electrode providing the response with the highest amplitude.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
latencies evoked potentials allodynic tires
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland PEYRON, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Saint Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu de Saint Etienne
City
Saint Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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