Diffuse DiseasesNCT03039166
Metabolic and Structural Characterization of Hub's Vulnerability in Neurological Diseases Assessed by Ultra High Field Structural and Functional MRI
A study testing MRI 7T, MRI 3 T and blood sample in people with Diffuse Diseases, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
the investigators hypothesize that hub alteration occurs both in diffuse diseases (MS, AD) as well as in more 'network specific' diseases (Parkinson, ALS, Epilepsy). This could impact on functional dysfunction not directly related to each disease, but that could induce common syndrome such as cognitive impairment… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diffuse Diseases
- What is being tested?
- MRI 7T, MRI 3 T and blood sample
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- May 2017to Oct 2022
- 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
- Person female or male, more than 18-year-old,
- Person presenting unchecked general disease such as severe cancer, autoimmune disease, hepatic insufficiency, severe or untreated, shady arterial high blood pressure of the conduction or the disorder of the rhythm
- Person presenting chronic psychiatric disease, insane syndrome.
- Person presenting contraindication to the realization of an examination by MRI (metallic claustrophobia, foreign body, pacemakers),
- Person benefiting from a social security cover,
- Person having read, understood and signed an informed consent after information
Who cannot join
- Claustrophobia,
- Metallic foreign bodies,
- Pacemakers,
- Severe renal insufficiency
Trial locations and contacts
1 site in 1 country.
maxime GUYE contact
France1 site
Assiatnce Publique Hopitaux de Marseille
Marseille, 13354
ALEXANDRA GIULIANI, drci@ap-hm.fr
MAXIME GUYE
About this study
the investigators hypothesize that hub alteration occurs both in diffuse diseases (MS, AD) as well as in more 'network specific' diseases (Parkinson, ALS, Epilepsy). This could impact on functional dysfunction not directly related to each disease, but that could induce common syndrome such as cognitive impairment observed in Parkinson, partial epilepsy or ALS.
The objective here is to test this hypothesis and provides better understandings on pathophysiological processes affecting those highly connected regions in 'diffuse' and 'focal' neurological diseases.
Read more
The ultimate goal is to identify new clinical targets for trans-nosological approaches (DBS, cognitive rehabilitation ...).
Practically, the investigators will explore 200 patients classified in 5 cohorts of 40 patients suffering for MS, AD, Parkinson, ALS, Epilepsy, using the last advanced methods to assess structural and functional brain connectivity implemented on the human 7T MR scanner equipping the CEMEREM (CHU Timone, Marseille, only 50 similar MR scanners worldwide).
In addition to high resolution diffusion MRI and rs-fMRI, metabolic and ionic (sodium) mapping will complement the MR protocol to characterize the pathophysiological processes of hub injury. Sixty healthy controls will also be explored wih the same protocol for normal database.
The proposal aims at characterizing and comparing from a morphological-functional point of view, the hub regions of patients suffering from these five diseases, to demonstrate the pertinence to preserve hub integrity as a major therapeutic target whatever the disease.
- Conditions
- Diffuse Diseases
- Being tested
- MRI 7T, MRI 3 T, blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI 7TDevice
MRI 3 TDevice
blood sampleBiological
| Study group | Role | What they receive |
|---|---|---|
| parkinson | Experimental | Not described Receives: Device: MRI 7T; Device: MRI 3 T |
| partial epilepsy | Experimental | Not described Receives: Device: MRI 7T; Device: MRI 3 T |
| alzheimer disease | Experimental | Not described Receives: Device: MRI 7T; Device: MRI 3 T |
| multiple sclerosis | Experimental | Not described Receives: Device: MRI 7T; Device: MRI 3 T; Biological: blood sample |
| amyotrophic lateral sclerosis | Experimental | Not described Receives: Device: MRI 7T; Device: MRI 3 T |
| healthy control patients | Active comparator | Not described Receives: Device: MRI 7T; Device: MRI 3 T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Index of reorganization of the structural hubs (ks-Degree)
Measured: 5years
Secondary outcomes (4)
Concentrations of sodium within hubs
Measured: 5 years
Concentrations of Glutamate/Glutamine within hubs
Measured: 5 years
cortical Thicknesses within hubs
Measured: 5 years
Iron accumulation within hubs
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study startMay 2017 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine GEINDRE, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039166
- Sponsor's protocol ID
- 2016-A01785-46
- Other IDs
- 2016-46
- Status last verified
- Apr 2017
- First submitted
- 31 Jan 2017
- Last updated
- 14 Apr 2017
- 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 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Structural Characterization of Hub's Vulnerability in Neurological Diseases Assessed by Ultra High Field Structural and Functional MRI
- ClinicalTrials.gov ID
- NCT03039166
- Acronym / sponsor ID
- 2016-A01785-46
- Conditions
- Diffuse Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- May 2017 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 1 Feb 2017 (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 investigators hypothesize that hub alteration occurs both in diffuse diseases (MS, AD) as well as in more 'network specific' diseases (Parkinson, ALS, Epilepsy). This could impact on functional dysfunction not directly related to each disease, but that could induce common syndrome such as cognitive impairment observed in Parkinson, partial epilepsy or ALS.
The objective here is to test this hypothesis and provides better understandings on pathophysiological processes affecting those highly connected regions in 'diffuse' and 'focal' neurological diseases.
The ultimate goal is to identify new clinical targets for trans-nosological approaches (DBS, cognitive rehabilitation ...).
Practically, the investigators will explore 200 patients classified in 5 cohorts of 40 patients suffering for MS, AD, Parkinson, ALS, Epilepsy, using the last advanced methods to assess structural and functional brain connectivity implemented on the human 7T MR scanner equipping the CEMEREM (CHU Timone, Marseille, only 50 similar MR scanners worldwide).
In addition to high resolution diffusion MRI and rs-fMRI, metabolic and ionic (sodium) mapping will complement the MR protocol to characterize the pathophysiological processes of hub injury. Sixty healthy controls will also be explored wih the same protocol for normal database.
The proposal aims at characterizing and comparing from a morphological-functional point of view, the hub regions of patients suffering from these five diseases, to demonstrate the pertinence to preserve hub integrity as a major therapeutic target whatever the disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| parkinson | Experimental | Device: MRI 7T, Device: MRI 3 T |
| partial epilepsy | Experimental | Device: MRI 7T, Device: MRI 3 T |
| alzheimer disease | Experimental | Device: MRI 7T, Device: MRI 3 T |
| multiple sclerosis | Experimental | Device: MRI 7T, Device: MRI 3 T, Biological: blood sample |
| amyotrophic lateral sclerosis | Experimental | Device: MRI 7T, Device: MRI 3 T |
| healthy control patients | Active comparator | Device: MRI 7T, Device: MRI 3 T |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Person female or male, more than 18-year-old,
- Person presenting unchecked general disease such as severe cancer, autoimmune disease, hepatic insufficiency, severe or untreated, shady arterial high blood pressure of the conduction or the disorder of the rhythm
- Person presenting chronic psychiatric disease, insane syndrome.
- Person presenting contraindication to the realization of an examination by MRI (metallic claustrophobia, foreign body, pacemakers),
- Person benefiting from a social security cover,
Key exclusion criteria (4 listed)
- Claustrophobia,
- Metallic foreign bodies,
- Pacemakers,
- Severe renal insufficiency
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 |
|---|---|---|
| MRI 7T | Device | alzheimer disease, amyotrophic lateral sclerosis, healthy control patients, multiple sclerosis, parkinson, partial epilepsy |
| MRI 3 T | Device | alzheimer disease, amyotrophic lateral sclerosis, healthy control patients, multiple sclerosis, parkinson, partial epilepsy |
| blood sample | Biological | multiple sclerosis |
Primary outcome
Index of reorganization of the structural hubs (ks-Degree)
Time frame: 5years
4 secondary outcomes
Concentrations of sodium within hubs
Time frame: 5 years
Concentrations of Glutamate/Glutamine within hubs
Time frame: 5 years
cortical Thicknesses within hubs
Time frame: 5 years
Iron accumulation within hubs
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- 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.
maxime GUYE contact
Catherine GEINDRE study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI 7T, MRI 3 T and blood sample in people with Diffuse Diseases, run by Assistance Publique Hopitaux De Marseille 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 6 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: status not confirmed, as of the sponsor's last update on 14 Apr 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact maxime GUYE (maxime.guye@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Index of reorganization of the structural hubs (ks-Degree) (time frame: 5years). 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 Apr 2017.