Difference in Regional Brain ActivityBIO7NCT05377671
Backward Masking Tasks to Decipher Impaired Input-Output Connections in MS @7T
A study testing IRM multimodale a ultra-haute camp in people with Difference in Regional Brain Activity, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system. People with MS frequently suffer from cognitive and visual impairment. Moreover, patients rank cognition and vision as two of the three most valuable bodily functions, in addition to mobility. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Difference in Regional Brain Activity
- What is being tested?
- IRM multimodale a ultra-haute camp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2022to Jan 2024
- 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
- Adult patients (>= 18 years of age) with MS defined according to the McDonald criteria 2017 (Thompson et al., 2018)
- For the group of patients without cognitive impairment: SDMT or PASAT >=0 (based previous clinical assessments)
- For the group of patients with cognitive impairment: SD SDMT or PASAT <= -1.5 (based based on previous clinical assessments) (Parmenter et al., 2007)
- Person without uncontrolled systemic disease such as cancer, autoimmune disease, liver failure, severe or untreated hypertension, conduction conduction disorder or severe rhythm disorder
- No one with chronic psychiatric illness, severe dementia syndrome demented syndrome.
- No contraindication to MRI examination (claustrophobia, metallic foreign bodies, pacemakers),
- A person with social security coverage,
- Person having read, understood and signed an informed consent after information
Who cannot join
- Pregnant women
- Other inflammatory demyelinating diseases of the CNS
- Usual contraindications for an MRI examination: claustrophobia, metallic foreign bodies pacemakers, severe renal insufficiency.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux Marseille
Marseille, Bouches Du Rhône, 13354
Alexandra GIULIANI, alexandra.giuliani@ap-hm.fr
About this study
Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system. People with MS frequently suffer from cognitive and visual impairment. Moreover, patients rank cognition and vision as two of the three most valuable bodily functions, in addition to mobility. Here the investigator use the established backward masking paradigm to study structural and functional alteration at the sub-milimeter scale in ultra-high field MRI in order to decipher the different input-output loops associated with the preservation and alteration of cognition in MS.
Read the detailed description
To identify abnormalities in mesoscale input and output connectivity at structural and functional levels that differ between patients with and without cognitive impairment. To address this objective, the investigator will analyse and compare functional activations in the primary visual cortex and task-associated regions in our previous studies. Secondary objectives: To develop, improve and validate multimodal laminar imaging at ultra-high field strength (7T) in comparison to control subjects available in our database to identify and quantify focal impairment in MS.
This is a cross-sectional study. 40 patients (20 patients with a cognitive deficit at least 2 SD below the norm and 20 patients without cognitive impairment) will be explored by multimodal ultra-high field (7T) MRI. The protocol included task, resting FMRI (functional connectivity), diffusion tensor (structural connectivity) and anatomical sequences (lesions and atrophy). In addition, the investigator will analyse standard clinical assessments including a neuropsychological examination. To understand the mechanisms underlying neurodegeneration and adaptation, it is important to contrast physiological and pathological alterations. In addition to comparing cognitively preserved and cognitively impaired patients, the investigator aim to compare our participants to a representative normative dataset available in our database of healthy individuals.
- Conditions
- Difference in Regional Brain Activity
- Being tested
- IRM multimodale a ultra-haute camp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRM multimodale a ultra-haute campDiagnostic test
The MRI includes, in addition to structural task sequences, diffusion imaging and resting state fMRI.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive deficit group | Experimental | All patients will undergo task MRI and standard clinical assessments, including neuropsychological examination. The MRI includes, in addition to structural task sequences, diffusion imaging and resting state fMRI. Receives: Diagnostic Test: IRM multimodale a ultra-haute camp |
| Without cognitive group | Experimental | All patients will undergo task MRI and standard clinical assessments, including neuropsychological examination. The MRI includes, in addition to structural task sequences, diffusion imaging and resting state fMRI. Receives: Diagnostic Test: IRM multimodale a ultra-haute camp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in regional brain activity between patients with and without cognitive impairment measured by the Bold signal
The explorations will be performed on a very high field imager (7T Terra, Siemens, Erlangen) dedicated to the research.
Measured: 1 year
Secondary outcomes (4)
Cognitive performance
The precision corresponding to the % of correct answers.
Measured: 1 year
Morphology
Cortical thickness. Next, the investigator will use Freesurfer (www.surfer.nmr.mgh.harvard.edu) to perform a vertex-wise cross-sectional comparison of cortical thickness between the two groups using a general linear model (GLM) controlling for age and sex. In a second model, the association between cortical thickness and time to conscious treatment will be calculated, also corrected for age and sex in the GLM. The results per vertex were corrected by the false discovery rate (FDR) at a threshold of p < 0.05.
Measured: 1 year
Structural connectivity
The investigator will use the average FA to construct weighted connectivity matrices between 160 nodes (80 cortical regions per hemisphere) based on the Destrieux atlas. "Strength", as a measure of regional structural connectivity, was calculated as the sum of weighted connections within and between each node for each subject.
Measured: 1 year
Functional connectivity
First, the investigator will perform preprocessing of the resting fMRI data, including correction for motion distortion and slice synchronization and cor- gistration with T1 volume and regional parcellation using SPM12. Then, all voxels in each region and time points will be averaged after application of the regression procedure for head motion, cerebrospinal fluid signals, white matter signals, and the overall average signal. After the preprocessing step, the output data acquired from the averaged region time series were used to perform wavelet analysis (frequency band: 0.1 Hz - 0.05 Hz, TR=2.5 s) using the brainwaver package in R. To calculate the raw functional connectivity, the investigator will calculate the absolute Pearson correlations between the time series of the wavelet coefficients of each region. For better comparability of the networks, the top 15% of connections defined the connectivity matrices. The degree of the nodes is the primary evaluation criterion.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start13 Oct 2022
- Primary completionOct 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difference in Regional Brain ActivityStudies 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
- Model description
- 40 patients (20 patients with a cognitive deficit at least 2 SD below the norm and 20 patients without cognitive impairment) will be explored by multimodal ultra-high field (7T) MRI
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, ASSISTANCE PUBLIQUE HOPITAUX MARSEILLEJan-Patrick STELLMANN, Principal investigator, ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377671
- Sponsor's protocol ID
- 2022-A00174-39
- Other IDs
- 2021-32
- Acronym
- BIO7
- Status last verified
- Oct 2022
- First submitted
- 10 May 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Backward Masking Tasks to Decipher Impaired Input-Output Connections in MS @7T
- ClinicalTrials.gov ID
- NCT05377671
- Acronym / sponsor ID
- BIO7 / 2022-A00174-39
- Conditions
- Difference in Regional Brain Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 17 May 2022 (actual)
- 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.
Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system. People with MS frequently suffer from cognitive and visual impairment. Moreover, patients rank cognition and vision as two of the three most valuable bodily functions, in addition to mobility. Here the investigator use the established backward masking paradigm to study structural and functional alteration at the sub-milimeter scale in ultra-high field MRI in order to decipher the different input-output loops associated with the preservation and alteration of cognition in MS.
Detailed description
To identify abnormalities in mesoscale input and output connectivity at structural and functional levels that differ between patients with and without cognitive impairment. To address this objective, the investigator will analyse and compare functional activations in the primary visual cortex and task-associated regions in our previous studies. Secondary objectives: To develop, improve and validate multimodal laminar imaging at ultra-high field strength (7T) in comparison to control subjects available in our database to identify and quantify focal impairment in MS.
This is a cross-sectional study. 40 patients (20 patients with a cognitive deficit at least 2 SD below the norm and 20 patients without cognitive impairment) will be explored by multimodal ultra-high field (7T) MRI. The protocol included task, resting FMRI (functional connectivity), diffusion tensor (structural connectivity) and anatomical sequences (lesions and atrophy). In addition, the investigator will analyse standard clinical assessments including a neuropsychological examination. To understand the mechanisms underlying neurodegeneration and adaptation, it is important to contrast physiological and pathological alterations. In addition to comparing cognitively preserved and cognitively impaired patients, the investigator aim to compare our participants to a representative normative dataset available in our database of healthy individuals.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 40 patients (20 patients with a cognitive deficit at least 2 SD below the norm and 20 patients without cognitive impairment) will be explored by multimodal ultra-high field (7T) MRI
| Arm | Type | Receives |
|---|---|---|
| Cognitive deficit group | Experimental | Diagnostic Test: IRM multimodale a ultra-haute campAll patients will undergo task MRI and standard clinical assessments, including neuropsychological examination. The MRI includes, in addition to structural task sequences, diffusion imaging and resting state fMRI. |
| Without cognitive group | Experimental | Diagnostic Test: IRM multimodale a ultra-haute campAll patients will undergo task MRI and standard clinical assessments, including neuropsychological examination. The MRI includes, in addition to structural task sequences, diffusion imaging and resting state fMRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients (>= 18 years of age) with MS defined according to the McDonald criteria 2017 (Thompson et al., 2018)
- For the group of patients without cognitive impairment: SDMT or PASAT >=0 (based previous clinical assessments)
- For the group of patients with cognitive impairment: SD SDMT or PASAT <= -1.5 (based based on previous clinical assessments) (Parmenter et al., 2007)
- Person without uncontrolled systemic disease such as cancer, autoimmune disease, liver failure, severe or untreated hypertension, conduction conduction disorder or severe rhythm disorder
- No one with chronic psychiatric illness, severe dementia syndrome demented syndrome.
Key exclusion criteria (3 listed)
- Pregnant women
- Other inflammatory demyelinating diseases of the CNS
- Usual contraindications for an MRI examination: 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 |
|---|---|---|
| IRM multimodale a ultra-haute campThe MRI includes, in addition to structural task sequences, diffusion imaging and resting state fMRI. | Diagnostic test | Cognitive deficit group, Without cognitive group |
Primary outcome
Difference in regional brain activity between patients with and without cognitive impairment measured by the Bold signal
Time frame: 1 year
The explorations will be performed on a very high field imager (7T Terra, Siemens, Erlangen) dedicated to the research.
4 secondary outcomes
Cognitive performance
Time frame: 1 year
Morphology
Time frame: 1 year
Structural connectivity
Time frame: 1 year
Functional connectivity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
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.
François CREMIEUX study director
ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
Jan-Patrick STELLMANN principal investigator
ASSISTANCE PUBLIQUE HOPITAUX 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 IRM multimodale a ultra-haute camp in people with Difference in Regional Brain Activity, 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 8 inclusion and 3 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 19 Oct 2022. 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 Jan-Patrick STELLMANN (06.46.28.97.89, jan-patrick.stellmann@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in regional brain activity between patients with and without cognitive impairment measured by the Bold signal (time frame: 1 year). 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 19 Oct 2022.