NCT02527590

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 17, 2018

Status Verified

August 1, 2016

Enrollment Period

6.8 years

First QC Date

August 11, 2015

Last Update Submit

January 15, 2018

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • latencies evoked potentials allodynic tires

    Day 1

Study Arms (2)

patient with neuropathic pain with allodynia

EXPERIMENTAL
Other: pneumatic stimulations(allodynic area)Other: pneumatic stimulations (healthy area)Other: no stimulation (control)

healthy volunteers

EXPERIMENTAL
Other: pneumatic stimulations no auditory maskingOther: no stimulation (control)Other: pneumatic stimulations with audidory masking

Interventions

pneumatic stimulations(allodynic area)OTHER

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

patient with neuropathic pain with allodynia
pneumatic stimulations (healthy area)OTHER

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

patient with neuropathic pain with allodynia
pneumatic stimulations no auditory maskingOTHER

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

healthy volunteers
no stimulation (control)OTHER

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

healthy volunteerspatient with neuropathic pain with allodynia
pneumatic stimulations with audidory maskingOTHER

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

healthy volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Diseases affecting the nervous system,
  • Diabetes,
  • Patients who received chemotherapy
  • Pregnant woman
  • Nobody in emergencies
  • A person unable to give consent
  • Major subject
  • Subject affiliated or entitled to a social security scheme
  • Subject has given its consent to participate in the study
  • Diseases affecting the nervous system,
  • Diabetes,
  • Patients who received chemotherapy
  • Pregnant woman
  • Nobody in emergencies
  • A person unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Saint Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Roland PEYRON, MD

    Centre Hospitalier Universitaire de Saint Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2015

First Posted

August 19, 2015

Study Start

February 1, 2011

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 17, 2018

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)