Sustained Attention Abilities in Schizophrenia (ACCRAS)

September 13, 2021 updated by: University Hospital, Strasbourg, France

Sustained Attention Abilities, Attentional Resources and Cognitive Control Mechanisms in Schizophrenia

Schizophrenia is a psychiatric pathology, which concerns around 1% of adult population. It is characterized by clinical symptoms combining positive and negative symptoms and thinking disorganization. Schizophrenia is also characterized by cognitive deficits, likely to play an important part in adaptation of these patients in their every-day life, and to affect their clinical symptomatology. Among them, there are deficits in sustained attention which are associated with a difficulty for these patients to maintain efficiently their cognitive activity on a source of stimulation or task. This basic attentional process is fundamental for the efficiency of the overall of cognitive processes, and so for all behaviors directed on an aim. The question of whether or not patients with schizophrenia have difficulty sustaining attention is of high relevance, in the sense that it could undermine performance on nearly any task and so provide a compelling causal explanation of many other impairments observed in these patients. Yet it has not been conclusively answered in over four decades of research. Consequently, the main objective of the protocol is to evaluate sustained attention abilities in schizophrenic patients and to better understand the specific functioning of cognitive and neural mechanisms underlying these abilities (attentional resources and cognitive control mechanisms).

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

40 schizophrenic patients versus 40 healthy subjects matched

Description

Inclusion Criteria:

  • age between 18 and 60 years (include)
  • men or women volunteers, hospitalized or not
  • subject affiliated to an health insurance
  • subject having signed an informed consent (for patients):
  • presence of DSM-IV TR criteria for schizophrenia (American Psychiatric Association, 1994)

Exclusion criteria

  • a major somatic disorder or non stabilized
  • medical history likely to affect cerebral anatomy or to be linked to an abnormality (neonatal distress, neurochirurgical intervention, neurological disorders, stroke attack)
  • any disorders involved in the use of a psycho-active substance (as defined by the DSM-IV)
  • sensory disabling impairments, and specifically visual acuity < 8
  • general anaesthesia during the 3 months before the study
  • pregnancy (declared by the subject)
  • persons in an emergency situation
  • persons deprived in any way of their liberty
  • persons in period of exclusion in an other protocol
  • use of psychotropic substance during the 3 weeks before the study
  • use of benzodiazepines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
assessing attention span
  • Electrophysiological measurements (evocated potentials and spectral densities)
  • Clinical scales and subjective assessments of difficulty of the tasks performed, and commitment to the task
performance measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess sustained attention span of patients with schizophrenia
Time Frame: two half-days
Subjects are involved in 4 different attentional tasks during which behavioral and electrophysiological measures are recorded in order to evaluate sustained attention abilities and the specific functioning of cognitive and neural mechanisms underlying these abilities in schizophrenic patients.
two half-days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study the specific mechanisms underlying attention skills supported in schizophrenic patients
Time Frame: two half-days
Subjects are involved in 4 different attentional tasks during which behavioral and electrophysiological measures are recorded in order to evaluate sustained attention abilities and the specific functioning of cognitive and neural mechanisms underlying these abilities in schizophrenic patients.
two half-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Giersch Anne, MD, Les Hôpitaux Universitaires de Strasbourg
  • Study Chair: Bonnefond Anne, PHD, Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

December 10, 2014

First Submitted That Met QC Criteria

March 9, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 5972

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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