NCT04182087

Brief Summary

This research relates to the study of cognitive deficits related to various focal brain lesions and their localizations in the brain. it involves building a large database of behavioural responses measured during the performance of cognitive tasks in patients with focal brain injury, to allow to better understand function of brain.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
46mo left

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Feb 2020Feb 2030

First Submitted

Initial submission to the registry

October 4, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 2, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

February 7, 2020

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2030

Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

10 years

First QC Date

October 4, 2019

Last Update Submit

January 15, 2024

Conditions

Focal Brain InjuryCognition

Keywords

Behavioral performanceCortical resectionStroke

Outcome Measures

Primary Outcomes (1)

  • Behavioral performance during cognitive tasks: Exploratory

    Behavioral performance during cognitive tasks evaluating attention, memory, language, executive functions and decision-making (reaction time, error rate, modeling parameters): Aggregated data depending of patient disorders linked to the localization of brain lesion and susceptible to evolve in the time (next 10 years).

    Data collection will be done on one or more routine visits at 3, 6, 12 or 24 months post lesion (so a maximum of four two-hour sessions)

Secondary Outcomes (1)

  • Behavioral performance (reaction time, error rate, modeling parameters): Exploratory

    Data collection will be done on one or more routine visits at 3, 6, 12 or 24 months post lesion (so a maximum of four two-hour sessions)

Study Arms (1)

Focal Brain Injury

Patients with focal brain injury (post-stroke or post-cortical resection)

Behavioral: Cognitive tasks

Interventions

Cognitive tasksBEHAVIORAL

Attention, language, memory, decision-making or executive functions

Focal Brain Injury

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult (Age between 18 and 70 years) patients with focal brain injury (post-stroke or post-cortical resection)

You may qualify if:

  • Male and female patients, 18-70 years old
  • A single, focal anatomical lesion of a given cerebral territory (post vascular, post surgical resection) documented by MRI
  • Intellectual ability and understanding of instructions compatible with the cognitive tasks to be performed

You may not qualify if:

  • Patient deprived of liberty
  • Somatic disorder likely to affect cognitive abilities
  • Pregnant or nursing woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Grenoble

Grenoble, 38043, France

RECRUITING

Related Publications (10)

  • Adolphs R. Human Lesion Studies in the 21st Century. Neuron. 2016 Jun 15;90(6):1151-1153. doi: 10.1016/j.neuron.2016.05.014.

    PMID: 27311080RESULT

  • Barbey AK, Colom R, Solomon J, Krueger F, Forbes C, Grafman J. An integrative architecture for general intelligence and executive function revealed by lesion mapping. Brain. 2012 Apr;135(Pt 4):1154-64. doi: 10.1093/brain/aws021. Epub 2012 Mar 6.

    PMID: 22396393RESULT

  • Clark L, Bechara A, Damasio H, Aitken MR, Sahakian BJ, Robbins TW. Differential effects of insular and ventromedial prefrontal cortex lesions on risky decision-making. Brain. 2008 May;131(Pt 5):1311-22. doi: 10.1093/brain/awn066. Epub 2008 Apr 3.

    PMID: 18390562RESULT

  • Deman P, Bhattacharjee M, Tadel F, Job AS, Riviere D, Cointepas Y, Kahane P, David O. IntrAnat Electrodes: A Free Database and Visualization Software for Intracranial Electroencephalographic Data Processed for Case and Group Studies. Front Neuroinform. 2018 Jul 6;12:40. doi: 10.3389/fninf.2018.00040. eCollection 2018.

    PMID: 30034332RESULT

  • Dronkers NF, Wilkins DP, Van Valin RD Jr, Redfern BB, Jaeger JJ. Lesion analysis of the brain areas involved in language comprehension. Cognition. 2004 May-Jun;92(1-2):145-77. doi: 10.1016/j.cognition.2003.11.002.

    PMID: 15037129RESULT

  • Kos C, van Tol MJ, Marsman JB, Knegtering H, Aleman A. Neural correlates of apathy in patients with neurodegenerative disorders, acquired brain injury, and psychiatric disorders. Neurosci Biobehav Rev. 2016 Oct;69:381-401. doi: 10.1016/j.neubiorev.2016.08.012. Epub 2016 Aug 12.

    PMID: 27527825RESULT

  • Muller NG, Knight RT. The functional neuroanatomy of working memory: contributions of human brain lesion studies. Neuroscience. 2006 Apr 28;139(1):51-8. doi: 10.1016/j.neuroscience.2005.09.018. Epub 2005 Dec 15.

    PMID: 16352402RESULT

  • Petersen SE, Posner MI. The attention system of the human brain: 20 years after. Annu Rev Neurosci. 2012;35:73-89. doi: 10.1146/annurev-neuro-062111-150525. Epub 2012 Apr 12.

    PMID: 22524787RESULT

  • Rorden C, Karnath HO. Using human brain lesions to infer function: a relic from a past era in the fMRI age? Nat Rev Neurosci. 2004 Oct;5(10):813-9. doi: 10.1038/nrn1521.

    PMID: 15378041RESULT

  • Sperber C, Karnath HO. On the validity of lesion-behaviour mapping methods. Neuropsychologia. 2018 Jul 1;115:17-24. doi: 10.1016/j.neuropsychologia.2017.07.035. Epub 2017 Aug 3.

    PMID: 28782546RESULT

MeSH Terms

Conditions

Brain InjuriesStroke

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • Philippe Kahane, MD, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

  • Julien Bastin, PhD

    Grenoble Institute of Neurosciences

    STUDY CHAIR

Central Study Contacts

Philippe Kahane, MD, PhD

CONTACT

+33 476 765 488pkahane@chu-grenoble.fr

Julien Bastin, PhD

CONTACT

+33 456 520 627julien.bastin@univ-grenoble-alpes.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2019

First Posted

December 2, 2019

Study Start

February 7, 2020

Primary Completion (Estimated)

February 6, 2030

Study Completion (Estimated)

February 6, 2030

Last Updated

January 17, 2024

Record last verified: 2024-01

Locations

FR(1)