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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02527590
Acronym
STIMEA
Enrollment
71
Registered
2015-08-19
Start date
2011-02-28
Completion date
2017-12-31
Last updated
2018-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathic Pain

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.

Interventions

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 masking

2 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 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.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
composite outcomes : latencies and amplitudes of pneumatic evoked potentialDay 1latencies (in ms) and peak-to-peak amplitudes (in μV) were measured on the electrode providing the response with the highest amplitude.

Secondary

MeasureTime frameDescription
latencies evoked potentials allodynic tiresDay 1The 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026