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

NCT ID: NCT02527590

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2017-12-31

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.

Conditions

Neuropathic Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

patient with neuropathic pain with allodynia

Group Type: EXPERIMENTAL

pneumatic stimulations(allodynic area)

Intervention Type: OTHER

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

pneumatic stimulations (healthy area)

Intervention Type: 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

no stimulation (control)

Intervention Type: OTHER

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

healthy volunteers

Group Type: EXPERIMENTAL

pneumatic stimulations no auditory masking

Intervention Type: OTHER

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

no stimulation (control)

Intervention Type: OTHER

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

pneumatic stimulations with audidory masking

Intervention Type: OTHER

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

Interventions

pneumatic stimulations(allodynic area)

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

Intervention Type: 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

Intervention Type: OTHER

pneumatic stimulations no auditory masking

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

Intervention Type: OTHER

no stimulation (control)

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Major subject
• Subject affiliated or entitled to a social security scheme
• Subject has given its consent to participate in the study

Exclusion Criteria

• Diseases affecting the nervous system,
• Diabetes,
• Patients who received chemotherapy
• Pregnant woman
• Nobody in emergencies
• A person unable to give consent

• Diseases affecting the nervous system,
• Diabetes,
• Patients who received chemotherapy
• Pregnant woman
• Nobody in emergencies
• A person unable to give consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roland PEYRON, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Saint Etienne

Locations

Chu de Saint Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2010-A00568-31

Identifier Type: OTHER

Identifier Source: secondary_id

1008057

Identifier Type: -

Identifier Source: org_study_id