Neuropathic PainSTIMEANCT02527590
Development of Stimulator Pneumatic for Realization of Evoked Potential Allodynic/Somatosensory
A study testing pneumatic stimulations(allodynic area), pneumatic stimulations (healthy area) and pneumatic stimulations no auditory masking in people with Neuropathic Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- pneumatic stimulations(allodynic area), pneumatic stimulations (healthy area) and pneumatic stimulations no auditory masking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diseases affecting the nervous system,
- Diabetes,
- Patients who received chemotherapy
- Pregnant woman
- Nobody in emergencies
- A person unable to give consent
Show all 12Show fewer
- Diseases affecting the nervous system,
- Diabetes,
- Patients who received chemotherapy
- Pregnant woman
- Nobody in emergencies
- A person unable to give consent
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- pneumatic stimulations(allodynic area), pneumatic stimulations (healthy area), pneumatic stimulations no auditory masking, no stimulation (control), pneumatic stimulations with audidory masking
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneumatic stimulations(allodynic area)Other
2 series of 20 pneumatic stimulations (air jet) on a allodynic area for recording evoked potentials
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
pneumatic stimulations no auditory maskingOther
2 series of pneumatic stimulations (air jet) on the hand (without feeling pain) for recording evoked potentials
no stimulation (control)Other
no stimulation (control condition): air jet directed beside the hand
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.
| Study group | Role | What they receive |
|---|---|---|
| patient with neuropathic pain with allodynia | Experimental | Not described Receives: Other: pneumatic stimulations(allodynic area); Other: pneumatic stimulations (healthy area); Other: no stimulation (control) |
| healthy volunteers | Experimental | Not described Receives: Other: pneumatic stimulations no auditory masking; Other: no stimulation (control); Other: pneumatic stimulations with audidory masking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (1)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startFeb 2011
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland PEYRON, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527590
- Sponsor's protocol ID
- 1008057
- Other IDs
- 2010-A00568-31
- Acronym
- STIMEA
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2015
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Stimulator Pneumatic for Realization of Evoked Potential Allodynic/Somatosensory
- ClinicalTrials.gov ID
- NCT02527590
- Acronym / sponsor ID
- STIMEA / 1008057
- Conditions
- Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment rate
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Feb 2011 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 masking, Other: no stimulation (control), Other: pneumatic stimulations with audidory masking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- Diseases affecting the nervous system,
- Diabetes,
- Patients who received chemotherapy
- Pregnant woman
- Nobody in emergencies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pneumatic stimulations(allodynic area)2 series of 20 pneumatic stimulations (air jet) on a allodynic area for recording evoked potentials | Other | patient with neuropathic pain with allodynia |
| 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 | Other | patient with neuropathic pain with allodynia |
| pneumatic stimulations no auditory masking2 series of pneumatic stimulations (air jet) on the hand (without feeling pain) for recording evoked potentials | Other | healthy volunteers |
| no stimulation (control)no stimulation (control condition): air jet directed beside the hand | Other | healthy volunteers, patient with neuropathic pain with allodynia |
| pneumatic 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. | Other | healthy volunteers |
Primary outcome
composite outcomes : latencies and amplitudes of pneumatic evoked potential
Time frame: Day 1
latencies (in ms) and peak-to-peak amplitudes (in μV) were measured on the electrode providing the response with the highest amplitude.
1 secondary outcome
latencies evoked potentials allodynic tires
Time frame: Day 1
Results and safety
The study was stopped early (reason given: low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland PEYRON, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pneumatic stimulations(allodynic area), pneumatic stimulations (healthy area) and pneumatic stimulations no auditory masking in people with Neuropathic Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: low recruitment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite outcomes : latencies and amplitudes of pneumatic evoked potential (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.