Cognitive Remediation of Working Memory Post Head Trauma

Официальное название

Cognitive Remediation of Working Memory After Moderate to Severe Head Trauma. a SCED Study.

Обзор

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.

Подробное описание

This study is a multiple baseline Single Case Experimental Design (SCED) across 3 patients and 2 behaviors (working memory performance, application of compensatory strategies).

The remediation program will include 4 intervention phases, and include patients with moderate or severe head trauma and expressing a cognitive complaint of working memory during the neuropsychological screening examination.

These patients will benefit from a neuropsychological assessment at inclusion then cognitive remediation treatment consisting of 4 phases. The duration of the baseline will be randomized. At the end of phases C and D, a new neuropsychological examination will be carried out.

Patients will have to come twice a week, for 12 weeks. All sessions will be individual.

* Phase A: Therapeutic education (Weeks 1 to 4) This first phase will include therapeutic education sessions lasting 90 minutes. The themes covered will concern Head trauma in the chronic phase. Cognitive and behavioral disorders secondary to traumatic brain injury (TBI) will not be addressed. The duration of this phase will be randomized. * Phase B: tDCS + therapeutic education (Weeks 5 to 8) During this intervention phase, at each visit patients will have 20 minutes of tDCS stimulation and 70 minutes of therapeutic education.

Concerning tDCS stimulation, an electrical current of 2mA will be delivered using the electrodes for 20 min. The content of the therapeutic education sessions will be developed in the same way as for phase A.

• Phase C: tDCS + cognitive remediation (Weeks 9 to 12) During this intervention phase, at each visit, patients will have 20 minutes of tDCS stimulation and 70 minutes of specific cognitive remediation of working memory.

The cognitive remediation program will combine working memory retraining using computerized and paper-and-pencil supports as well as more ecological exercises that respond precisely to the difficulties encountered by the patient in daily life.

Вмешательства

• Другое therapeutic education
  The themes covered concern head trauma in the chronic phase.
• Другое 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.
• Другое 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 com

Первичные конечные точки

• Working memory performance [Срок оценки: 8 weeks after baseline]

Вторичные конечные точки (1)

• Goal attainment [Срок оценки: 8 weeks after baseline]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• UH Toulouse — Toulouse

Идентификаторы

NCT: NCT06077695 · RC31/22/0502

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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