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

Neuropathic Pain Clinical Trial

— STIMEA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02527590
• Other study ID #: 1008057
• Secondary ID: 2010-A00568-31
• Status: Terminated
• Phase: N/A
• First received: August 11, 2015
• Last updated: January 15, 2018
• Start date: February 2011
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 71
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Other:
• pneumatic stimulations(allodynic area)
2 series of 20 pneumatic stimulations (air jet) on a allodynic area for recording evoked potentials
• 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
• pneumatic stimulations no auditory masking
2 series of pneumatic stimulations (air jet) on the hand (without feeling pain) for recording evoked potentials
• no stimulation (control)
no stimulation (control condition): air jet directed beside the hand
• 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.

Locations

Country	Name	City	State
France	Chu de Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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