Neuropathic PainALLONCT02858479
Structural and Functional Brain Reorganization in Neuropathic Pain. Influences of the Loss of Sensitivity and the Atrophy Cortical on Activations Due to Stimulation Allodynic
A study testing stimulation on painful area (area allodynic), same stimulation on non-painful area and MRI scan in people with Neuropathic Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Neuropathic pain is a medical condition involving allodynia (painful perceptions in response to stimuli that normally are not) and spontaneous pain (occurring at rest, without stimulation). This pain is secondary to nervous system injury affecting the sensory system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- stimulation on painful area (area allodynic), same stimulation on non-painful area and MRI scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 25 Mar 2016to 11 Feb 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- with neuropathic pain
- in the case of central lesions, the lesion must be unique and small
- treatment not stable opioid for one week
- consent signed
Who cannot join
- severe psychiatric history
- presence of an evolutive lesion, expansive, cancerous or tumorous underlying
- patient needing of opioid therapy
- contraindication at MRI scan
Trial locations and contacts
1 site in 1 country.
About this study
Neuropathic pain is a medical condition involving allodynia (painful perceptions in response to stimuli that normally are not) and spontaneous pain (occurring at rest, without stimulation).
This pain is secondary to nervous system injury affecting the sensory system. The lesion is either at the nerve endings of the spinal cord or brain. It induces a loss of sensitivity and reorganization of brain activity.
Read more
Previous studies in functional neuroimaging have focused on brain areas activated during allodynic stimuli compared to non-painful stimuli. The abnormalities have been reported, but it was not possible to conclude formally.
The objective of this study is to understand the brain dysfunction that induces allodynic pain considering the deafferentation of each patient and possible cortical losses.
- Conditions
- Neuropathic Pain
- Being tested
- stimulation on painful area (area allodynic), same stimulation on non-painful area, MRI scan
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stimulation on painful area (area allodynic)Other
these stimulations will be performed either with a brush, with a cold block or with forced air (cold air or air to ambient temp) : calibrated to induce pain bearable.
stimulations for 6 seconds
same stimulation on non-painful areaOther
these stimulations will be performed either with a brush, with a cold block or with forced air (cold air or air to ambient temp) : calibrated to induce pain bearable.
stimulations for 6 seconds
MRI scanRadiation
2 sessions for 10 minutes :
- 11 controls stimulations for 6 s each spaced 20 s without stimulation.
- 11 allodynic stimulations for 6 s each spaced 20 s without stimulation.
| Study group | Role | What they receive |
|---|---|---|
| patients with pain allodynic peripheral | Other | Not described Receives: Other: stimulation on painful area (area allodynic); Other: same stimulation on non-painful area; Radiation: MRI scan |
| patients with pain allodynic central | Other | Not described Receives: Other: stimulation on painful area (area allodynic); Other: same stimulation on non-painful area; Radiation: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
the deafferentation rate
the deafferentation rate measured with thermo-test
Measured: at baseline
gray matter rate
gray matter rate measured with MRI scan
Measured: at baseline
Secondary outcomes (1)
Analysis pain
Measured by visual analogue scale (0 to 10)
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study start25 Mar 2016
- Primary completion11 Feb 2019
- Study completion11 Feb 2019
Why it stopped: failure to recruit
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
- 41 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland PEYRON, MD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858479
- Sponsor's protocol ID
- 1308174
- Other IDs
- 2013-A01791-44
- Acronym
- ALLO
- Status last verified
- Sep 2020
- First submitted
- 1 Aug 2016
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Functional Brain Reorganization in Neuropathic Pain. Influences of the Loss of Sensitivity and the Atrophy Cortical on Activations Due to Stimulation Allodynic
- ClinicalTrials.gov ID
- NCT02858479
- Acronym / sponsor ID
- ALLO / 1308174
- Conditions
- Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: failure to recruit
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 25 Mar 2016 (actual)
- Primary completion
- 11 Feb 2019 (actual)
- Study completion
- 11 Feb 2019 (actual)
- First posted
- 8 Aug 2016 (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.
Neuropathic pain is a medical condition involving allodynia (painful perceptions in response to stimuli that normally are not) and spontaneous pain (occurring at rest, without stimulation).
This pain is secondary to nervous system injury affecting the sensory system. The lesion is either at the nerve endings of the spinal cord or brain. It induces a loss of sensitivity and reorganization of brain activity.
Previous studies in functional neuroimaging have focused on brain areas activated during allodynic stimuli compared to non-painful stimuli. The abnormalities have been reported, but it was not possible to conclude formally.
The objective of this study is to understand the brain dysfunction that induces allodynic pain considering the deafferentation of each patient and possible cortical losses.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with pain allodynic peripheral | Other | Other: stimulation on painful area (area allodynic), Other: same stimulation on non-painful area, Radiation: MRI scan |
| patients with pain allodynic central | Other | Other: stimulation on painful area (area allodynic), Other: same stimulation on non-painful area, Radiation: MRI scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- with neuropathic pain
- in the case of central lesions, the lesion must be unique and small
- treatment not stable opioid for one week
- consent signed
Key exclusion criteria (4 listed)
- severe psychiatric history
- presence of an evolutive lesion, expansive, cancerous or tumorous underlying
- patient needing of opioid therapy
- contraindication at MRI scan
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 |
|---|---|---|
| stimulation on painful area (area allodynic)these stimulations will be performed either with a brush, with a cold block or with forced air (cold air or air to ambient temp) : calibrated to induce pain bearable. stimulations for 6 seconds | Other | patients with pain allodynic central, patients with pain allodynic peripheral |
| same stimulation on non-painful areathese stimulations will be performed either with a brush, with a cold block or with forced air (cold air or air to ambient temp) : calibrated to induce pain bearable. stimulations for 6 seconds | Other | patients with pain allodynic central, patients with pain allodynic peripheral |
| MRI scan2 sessions for 10 minutes : * 11 controls stimulations for 6 s each spaced 20 s without stimulation. * 11 allodynic stimulations for 6 s each spaced 20 s without stimulation. | Radiation | patients with pain allodynic central, patients with pain allodynic peripheral |
Primary outcome
the deafferentation rate
Time frame: at baseline
the deafferentation rate measured with thermo-test
gray matter rate
Time frame: at baseline
gray matter rate measured with MRI scan
1 secondary outcome
Analysis pain
Time frame: at baseline
Results and safety
The study was stopped early (reason given: failure to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- 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
CHU 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 stimulation on painful area (area allodynic), same stimulation on non-painful area and MRI scan 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 4 inclusion and 4 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 28 Sep 2020. 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: failure to recruit). 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?
the deafferentation rate (time frame: at baseline). The study lists 2 primary outcomes in all. 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 28 Sep 2020.