Painful Avulsion of Brachial PlexusCCPBNCT01104506
Elaboration of a Pre-surgery Mapping Protocol of Primary Motor Cortex, Prior to an Implementation of a Stimulation of Primary Motor Cortex for Patients With Deafferentiation of Brachial Plexus Pain
A study testing fMRI and mTMS in people with Painful Avulsion of Brachial Plexus, run by Nantes University Hospital at 1 site in France.
Trial summary
In the context of an insufficiency of clinical results for cortical stimulation in treatment of brachial plexus post-avulsion pains, one of the possibility for failure is the bad pre-surgery mapping of the area to stimulated bu the usual methods (PEM et fMRI). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Painful Avulsion of Brachial Plexus
- What is being tested?
- fMRI and mTMS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to Sep 2010
- 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
- For all groups: informed consent, social insurance
- For group 1 "painful BPA": consulting to the Nantes'UH for pain of BPA, EVA≥4, neurological deficiency partial or total
- For group 2 "painless BPA": EVA<4, neurological deficiency partial or total, matching with group 1 on the neurological deficiency
- For group 3 "Healthy": matching with group 1 on age ±10 years
Who cannot join
- No informed consent
- Medical history of epilepsy
- Pregnant women
- Contra-indication to MRI
Trial locations and contacts
1 site in 1 country.
About this study
In the context of an insufficiency of clinical results for cortical stimulation in treatment of brachial plexus post-avulsion pains, one of the possibility for failure is the bad pre-surgery mapping of the area to stimulated bu the usual methods (PEM et fMRI). This purpose of this study is to realise a precise mapping of the primary motor cortex post brachial plexus avulsion.
The principal endpoints is to identify and test the reliability of a muscular marker for which the cortical representation is localized immediately next to the superior member area. Several muscles of cephalic, cervical and chest area will be investigate.
Read more
The methods used will be mono-shock transcranial magnetic stimulation (mTMS) and functional MRI.
Concerning mTMS, several methods will be tested: best position on the scalp, realisation of outputs maps with extreme points average method, with mass center method.
Concerning fMRI studies, the above paradigms will be checked: imaginary movements of hand, blow up and down abdomen, eyes winking.
Statistical tests will confirm the best muscle candidate and will permit to evaluate the reliability of the method.
- Conditions
- Painful Avulsion of Brachial Plexus
- Being tested
- fMRI, mTMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIProcedure or surgery
mTMSProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Painless plexus | Active comparator | Patient with a painless avulsion of brachial plexus Receives: Procedure: fMRI; Procedure: mTMS |
| Healthy | Active comparator | Healthy volunteers Receives: Procedure: fMRI; Procedure: mTMS |
| Painful plexus | Experimental | Patient with a painful avulsion of brachial plexus Receives: Procedure: fMRI; Procedure: mTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the 2 muscles (lateral and medial) lining the representation of superior member according to Penfield's homunculus.
Spatial coordinates (xyz): calculation of the center of gravity of cortical surface suggestive of a specific muscle, using data acquired during each session.
Secondary outcomes (6)
Evaluation of primary outcome depending on cortical center
Calculation of cortical center evoking the maximal PEM
Evaluation of primary outcome depending on the center of cortical area
Calculation of the center of the cortical area suggestive of a precised muscle
Evaluation of primary outcome depending on cortical surface
Calculation of cortical surface suggestive of a precised muscle
Pain intensity
Pain intensity by using an visual analogic scale
Ghost sensations intensity
Ghost sensations intensity by a questionnaire
Amplitude of PEM
calculation of the amplitude of PEM for a precised muscle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Avulsion of Brachial PlexusStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104506
- Sponsor's protocol ID
- BRD 10/2-A
- Other IDs
- 2010-A00141-38
- Acronym
- CCPB
- Status last verified
- Apr 2010
- First submitted
- 8 Apr 2010
- Last updated
- 14 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elaboration of a Pre-surgery Mapping Protocol of Primary Motor Cortex, Prior to an Implementation of a Stimulation of Primary Motor Cortex for Patients With Deafferentiation of Brachial Plexus Pain
- ClinicalTrials.gov ID
- NCT01104506
- Acronym / sponsor ID
- CCPB / BRD 10/2-A
- Conditions
- Painful Avulsion of Brachial Plexus
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 15 Apr 2010 (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.
In the context of an insufficiency of clinical results for cortical stimulation in treatment of brachial plexus post-avulsion pains, one of the possibility for failure is the bad pre-surgery mapping of the area to stimulated bu the usual methods (PEM et fMRI). This purpose of this study is to realise a precise mapping of the primary motor cortex post brachial plexus avulsion.
The principal endpoints is to identify and test the reliability of a muscular marker for which the cortical representation is localized immediately next to the superior member area. Several muscles of cephalic, cervical and chest area will be investigate.
The methods used will be mono-shock transcranial magnetic stimulation (mTMS) and functional MRI.
Concerning mTMS, several methods will be tested: best position on the scalp, realisation of outputs maps with extreme points average method, with mass center method.
Concerning fMRI studies, the above paradigms will be checked: imaginary movements of hand, blow up and down abdomen, eyes winking.
Statistical tests will confirm the best muscle candidate and will permit to evaluate the reliability of the method.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Painless plexus | Active comparator | Procedure: fMRI, Procedure: mTMSPatient with a painless avulsion of brachial plexus |
| Healthy | Active comparator | Procedure: fMRI, Procedure: mTMSHealthy volunteers |
| Painful plexus | Experimental | Procedure: fMRI, Procedure: mTMSPatient with a painful avulsion of brachial plexus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- For all groups: informed consent, social insurance
- For group 1 "painful BPA": consulting to the Nantes'UH for pain of BPA, EVA≥4, neurological deficiency partial or total
- For group 2 "painless BPA": EVA<4, neurological deficiency partial or total, matching with group 1 on the neurological deficiency
- For group 3 "Healthy": matching with group 1 on age ±10 years
Key exclusion criteria (4 listed)
- No informed consent
- Medical history of epilepsy
- Pregnant women
- Contra-indication to MRI
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 |
|---|---|---|
| fMRI | Procedure or surgery | Healthy, Painful plexus, Painless plexus |
| mTMS | Procedure or surgery | Healthy, Painful plexus, Painless plexus |
Primary outcome
Identify the 2 muscles (lateral and medial) lining the representation of superior member according to Penfield's homunculus.
Spatial coordinates (xyz): calculation of the center of gravity of cortical surface suggestive of a specific muscle, using data acquired during each session.
6 secondary outcomes
Evaluation of primary outcome depending on cortical center
Evaluation of primary outcome depending on the center of cortical area
Evaluation of primary outcome depending on cortical surface
Pain intensity
Ghost sensations intensity
Amplitude of PEM
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2010.
Related trials for Painful Avulsion of Brachial Plexus
RecruitingObservational study
Neurostimulation for Treatment of Chronic Upper Limb Pain After Brachial Plexus Injury
Brachial Plexus Injury
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI and mTMS in people with Painful Avulsion of Brachial Plexus, run by Nantes University Hospital 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 14 Dec 2010. 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. 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?
Identify the 2 muscles (lateral and medial) lining the representation of superior member according to Penfield's homunculus.. 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 14 Dec 2010.