Clinical Trials Directory

Trials / Terminated

TerminatedNCT02527590

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
71 (actual)
Sponsor
Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
OTHERpneumatic stimulations(allodynic area)2 series of 20 pneumatic stimulations (air jet) on a allodynic area for recording evoked potentials
OTHERpneumatic 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
OTHERpneumatic stimulations no auditory masking2 series of pneumatic stimulations (air jet) on the hand (without feeling pain) for recording evoked potentials
OTHERno stimulation (control)no stimulation (control condition): air jet directed beside the hand
OTHERpneumatic stimulations with audidory masking2 series of 20 pneumatic stimulations (air jet) on the hand (without feeling pain) with auditory helmet that totally masked the air jet noise.

Timeline

Start date
2011-02-01
Primary completion
2017-12-01
Completion
2017-12-01
First posted
2015-08-19
Last updated
2018-01-17

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02527590. Inclusion in this directory is not an endorsement.