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Recruiting Not applicable

Cognitive Remediation of Working Memory Post Head Trauma

NCT06077695 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-11-06
Last updated
2026-08-07

Condition(s) studied

Head Trauma

Investigational drug(s) / intervention(s)

therapeutic educationtDCScognitive remediation

therapeutic education: The themes covered concern head trauma in the chronic phase.

tDCS: The constant electric current will be delivered at an intensity of 2 mA for 20 minutes.The anode will be placed opposite the dorsolateral prefrontal area on the right. The cathode (or reference electrode) will be positioned opposite the supraorbital area on the left. This methodology is based on the general directions and results from scientific studies which aimed to improve the efficiency of neural networks engaged in attentional processes and working memory.

cognitive remediation: Personalized sessions combining 2 approaches:•Retraining deficit components of working memory.exercise the strengthening of metacognition and the learning of "reorganization-facilitation" strategies. At the end of each exercise, the participant will be asked to analyze their performance and will benefit from feedback from the rehabilitator as well as a discussion on the use of the strategies. Finally, all of the proposed tasks will be made up of several levels of complexity; moving to a more complex stage will require more than 90% success in the exercise.•More ecological exercises will also be carried out in order to get as close as possible to the difficulties encountered by the patient on a daily basis. The examiner will guide the rehabilitation and propose tasks imitating his daily life.

Study summary

Patients with working memory deficits due to a moderate to severe head injury will undergo a 5 month protocol including cognitive remediation with numerous exercises, transcranial direct current stimulation (tDCS), and therapeutic education.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Working memory performance — 8 weeks after baseline
    difference in performance on a working memory task (2-back) between phase A (therapeutic education) and interventional phase C (t-DCS + cognitive remediation) : a 2-back task is a repeated measure of working memory performance. On each trial, a stimulus will appear in the center of the screen for 500 msec. It will be followed by an inter-stimulus phase of 1500 msec. The stimulus will be a capital letter (consonants only). In this 2-back task, the subject will be asked to press the answer key as quickly as possible when the letter presented is identical to the penultimate. This task requires strong working memory and attentional resources. Error-free delay (ms), reaction times (ms) and standard deviation of reaction times (ms) will be counted.

Trial sites (1)

FacilityCityRegionStatus
UH Toulouse Toulouse France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06077695 on ClinicalTrials.gov ↗ ← All trials in France