Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-24 @ 1:49 PM
NCT ID:
NCT06077695
Eligibility Criteria:
Inclusion Criteria:
* Moderate or severe head trauma, defined by an initial Glasgow score ≤ 12/15, duration of post-traumatic amnesia superior to 24 hours and/or the presence of abnormalities on brain imaging,
* Moderate or severe head trauma occurring within a period greater than or equal to 3 months,
* Working memory complaints assessed by the Working Memory Questionnaire,
* Patients with a working memory disorder in at least one of the following tests: Digit Memory subtest WAIS-IV (standard deviation ≤ -2) , PASAT (percentile ≤ 10), Brown-Peterson (standard deviation ≤ -2).
Exclusion Criteria:
* Presence of aphasia, apraxia or severe neglect demonstrated by standardized neuropsychological tests during the inclusion visit: language - oral naming of BECS-GRECO images, ideational praxis and ideomotor , neglect - bell test,
* Insufficient visual or auditory abilities and oral and written expression to carry out neuropsychological tests,
* Severe depression assessed by the Beck Depression Inventory (BDI)
* Chronic alcoholic poisoning, drug addiction,
* Progressive general illness,
* Progressive psychiatric or neurological condition leading to cognitive impairment,
* Hospitalization for a neurological pathology since the acute phase of the qualifying event,
* Patient requiring surgery during study participation.
* Pregnant or breastfeeding women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06077695
Study Brief:
Protocol Section:
NCT06077695