- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05377671
Backward Masking Tasks to Decipher Impaired Input-Output Connections in MS @7T (BIO7)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jan-Patrick STELLMANN
- Phone Number: 06.46.28.97.89
- Email: jan-patrick.stellmann@ap-hm.fr
Study Locations
-
-
Bouches Du Rhône
-
Marseille, Bouches Du Rhône, France, 13354
- Recruiting
- ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnant women
- Other inflammatory demyelinating diseases of the CNS
- Usual contraindications for an MRI examination: claustrophobia, metallic foreign bodies pacemakers, severe renal insufficiency.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive deficit group
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.
|
The MRI includes, in addition to structural task sequences, diffusion imaging and resting state fMRI.
|
Experimental: Without cognitive group
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.
|
The MRI includes, in addition to structural task sequences, diffusion imaging and resting state fMRI.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive performance
Time Frame: 1 year
|
The precision corresponding to the % of correct answers.
|
1 year
|
Morphology
Time Frame: 1 year
|
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.
|
1 year
|
Structural connectivity
Time Frame: 1 year
|
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.
|
1 year
|
Functional connectivity
Time Frame: 1 year
|
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.
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jan-Patrick STELLMANN, ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022-A00174-39
- 2021-32 (Other Identifier: sponsor reference)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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