Cognitive Remediation of Working Memory Post Head Trauma
ConditionHead Trauma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity Hospital, Toulouse
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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,
Trial design
Design model
Single group
Treatments tested in this trial
therapeutic education
Other interventionThe themes covered concern head trauma in the chronic phase.
tDCS
Other interventionThe 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
Other interventionPersonalized 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.
Treatment groups
9 Participants
are divided into 3 treatment groupsGroup A: 4 weeks phase A armExperimental treatment 3 interventions
Group B: 5 weeks phase A armExperimental treatment 3 interventions
Group C: 6 weeks phase A armExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Working memory performance
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.
Time frame
8 weeks after baselineSecondary outcomes
1
Goal attainment
The difference in Goal Attainment Scale (GAS) scores between phase A (therapeutic education) and interventional phase C (t-DCS + cognitive remediation). Each goal is personalized with the patient. The scale has 5 types of score each representing a goal attainment status (expectation) : * 2 being the further away form expectation * 1 a little less than aimed 0 meaning that the goal set is attained * 1 a little more than what was aimed * 2 exceeds a lot expectations
Time frame
8 weeks after baselineSponsors and contacts
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Source ClinicalTrials.gov