Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies (GREFEXII)

C

Centre Hospitalier Universitaire, Amiens

Status

Terminated

Conditions

Traumatic Brain Injury
Alzheimer Disease
Stroke
Frontal Dementia
Huntington Disease
Parkinson Disease

Treatments

Behavioral: social cognition

Study type

Interventional

Funder types

Other

Identifiers

NCT03052712
PI2015_843_0031

Details and patient eligibility

About

The role of disorders of socio-emotional processes in cerebral diseases such as Alzheimer's disease, frontal temporal dementia, Parkinson's disease, Huntington's disease, traumatic brain injury, stroke, focal lesions, has been recognized recently. Social cognition refers to a large group of emotional and cognitive abilities regulating inter-individuals relationships and it includes mainly theory of mind, emotional information processing and empathy. However, assessment of socio-emotional processes is still largely based on experimental tests that are not validated for clinical purpose. In addition their long duration of administration is not adapted to clinical examination. Finally these tests have not been standardized and normalized in French-speaking population.

Enrollment

44 patients

Sex

All

Ages

20 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Provision of signed and dated informed consent form (ICF)
  • Male or female, aged 20 to 80 years inclusive at the time of signing ICF
  • French-speaking

reliable informant

Controls:

derived from the general population and consenting to participate in the study

Patients:

MMS>18

Patients followed for mild or major neurocognitive disorder related to :

  • Alzheimer's disease
  • Frontotemporal lobar degeneration
  • Lewy bodies disease
  • Parkinson's disease
  • Huntington's disease
  • Progressive supranuclear palsy
  • traumatic brain injury
  • stroke or cerebral anoxia
  • mixed diseases
  • focal cerebral diseases

Exclusion criteria

  • Illiteracy
  • mental retardation
  • visual or motor deficit preventing reading, drawing or writing (scores on the reading, drawing or sentence writing subtests of the MMSE = 0)
  • hearing impairment interfering with understanding of instructions,
  • history of brain disease, including head injury with loss of consciousness lasting > 15 minutes, stroke, coma or loss of consciousness lasting > 15 minutes, followed for sclerosis or other brain disease, brain radiation therapy, epilepsy currently requiring treatment
  • history of psychiatric illness (schizophrenia or other psychosis) or ongoing psychiatric illness (major depressive disorder or other condition) currently requiring treatment or requiring a stay > 2 days in a psychiatry unit or anxiety requiring more than one medication at the present time
  • alcoholism (mean alcohol consumption > 3 standard drinks/day or history of alcohol withdrawal)
  • use of opiates or other illicit drugs during the previous 3 months or causing withdrawal syndrome
  • ongoing antidepressant or antiepileptic treatment
  • anxiolytic or hypnotic treatment initiated or increased during the previous month
  • general anaesthesia during the previous 3 months
  • history of heart surgery with cardiopulmonary bypass
  • comorbidities affecting cognition (respiratory, renal, liver, heart failure…)
  • women of childbearing potential (defined as pre-menopausal, less than 2 years postmenopausal, or not surgically sterile)

persons placed under judicial protection

Patients :

contraindication to MRI

Controls:

deficit on MMSE <27

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

44 participants in 2 patient groups

Patients
Active Comparator group
Description:
battery of tests of social cognition
Treatment:
Behavioral: social cognition
Control
Active Comparator group
Description:
battery of tests of social cognition
Treatment:
Behavioral: social cognition

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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