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Trial · NCT06852209

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryDifferential CEN-DMN activity and imaging contrast between regulation and restThrough study training completion, an average of 4 weeksChange from baseline to each training session on the CEN-DMN activity during regulation compared with rest, in the experimental and control groups
SecondaryEvolution of global cognition assessed by the Montreal Cognitive Assessment (MoCA)Through study completion, an average of 6 weeks
Change from baseline to the end of the study on the MoCA score. The MoCA score allows the detection of mild cognitive impairment and is ranged from 0 (minimum) to 30 (maximum : no cognitive impairment).
SecondaryEvolution of executive functions assessed by a composite scorethrough study completion, an average of 6 weeks
Change from baseline to the end of the study on a composite Z-score made from the averages of the Z-scores of the following tests : * verbal fluency : the subject is asked to cite a maximum of animals, letters starting with the letter P and V in 60 seconds) ; * memory span (working memory) : the subject is asked to restitute a maximum of the items of a list immediatly after hearing them) ; * Trail making Test (cognitive flexibility) : the subject is asked to link a set of digits in increasing order, alternating with letters, or items of different shapes or colors, the number of errors is recorded ; * Stroop task (inhibition capacity) : the subject is asked to name the font color of a list of words of colors which don't match their font color ; * Zoo testing plan (scheduling ability) : the subject is asked to follow a list of instructions for the visit of a zoo, while dealing with a list of constraints.
SecondaryEvolution of attentional functions assessed by the Mesulam cancellation taskThrough study completion, an average of 6weeks
Change from baseline to the end of the study on the Mesulam cancellation task : the subject is asked to cancel a specific target among random arrays of structured and unstructured verbal and nonverbal stimuli.
SecondaryEvolution of processing speed assessed by the Symbol Digit Modalities Test (SDMT)Through study completion, an average of 6 weeks
Change from baseline to the end of the study on the SDMT : the subject is provided with a set of symbols corresponding to numbers, and he is asked to write the symbols corresponding to a specific list of numbers in 5 minutes.
SecondaryEvolution of memory functions assessed by the 16-item Free and Cued RecallThrough study completion, an average of 6 weeks
Change from baseline to the end of the study on the 16-item Free and Cued Recall : the subject is asked to recall a set of 16 words presented by 4, immediately and after an interfering task, the number of free and cued correct recalls are recorded.
SecondaryEvolution of visuospatial functions assessed by the Rey figureThrough study completion, an average of 6 weeksChange from baseline to the end of the study on the Rey figure : the subject is asked to copy a complex figure as quickly as possible, and then, to reproduce the figure without the model.
SecondaryEvolution of language functions assessed byt the 40-item neuropsychological semantic batteryThrough study completion, an average of 6 weeks
Change from baseline to the end of the study on the 40-item neuropsychological semantic battery : the subject is asked to name a set of 40 living and non living items in verbal and visual conditions, across 6 subtests of matching.
SecondaryEvolution of the Central Executive Network (CEN) activityThrough study training completion, an average of 4 weeks
Change from baseline to each training session in the CEN activity recorded in the CEN mask during regulation compared with rest, in the experimental and control groups. The CEN mask is a binary mask individualized after running a pipeline for each subject, and the functional activity into this mask is extracted to assess the specific trajectory of the CEN activity.
SecondaryEvolution of the Default Mode Network (DMN) activityThrough study training completion, an average of 4 weeks
Change from baseline to each training session in the DMN activity recorded in the DMN mask during regulation compared with rest, in the experimental and control groups. The DMN mask is a binary mask individualized after running a pipeline for each subject, and the functional activity into this mask is extracted to assess the specific trajectory of DMN activity.
SecondaryEvolution of activity in the whole brainThrough study training completion, an average of 4 weeksChange from baseline to each training session on the whole brain activity during regulation compared with rest, in the experimental and control groups
SecondaryEvolution of resting state CEN and DMN activityThrough study completion, an average of 6 weeksChange in correlation between resting state CEN and DMN activity before intervention compared with after intervention.
SecondaryMicrostructural changes assessed by Fractional Anisotropy (FA)Through study completion, an average of 6 weeksChange in median FA parameters before intervention compared with after intervention
SecondaryMicrostructural changes assessed by Mean Diffusivity (MD)Through study completion, an average of 6 weeksChange in median MD parameters (mm2/sec) before intervention compared with after intervention
SecondaryMicrostructural changes assessed by Axial Diffusivity (AD)Through study completion, an average of 6 weeksChange in median AD parameters (mm2/sec) before intervention compared with after intervention
SecondaryMicrostructural changes assessed by Radial Diffusivity (RD)Through study completion, an average of 6 weeksChange in median RD parameters (mm2/sec) before intervention compared with after intervention
SecondaryDifferential CEN-DMN activity and imaging contrast between regulation and rest, without neurofeedbackThrough study completion, an average of 6 weeksChange from baseline to the last fMRI session (" transfert session " without neurofeedback) on the CEN-DMN activity during regulation compared with rest, in the experimental and control groups

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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