Cognitive Remediation of Working Memory After Moderate to Severe Head Trauma. a SCED Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Working memory performance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Repeated measurements, control measurements and neuropsychological examinations will be carried out by an examiner blinded to the intervention phase. The rehabilitator will not carry out these assessments. A neuropsychologist from the neuropsychology unit, not involved in the design and conduct of the Meta-SCED study, will carry out these examinations.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
4 weeks phase A arm
Phase A = Randomised duration of this phase : 4 weeks. each therapeutic therapeutic education sessions last 90 minutes.
Phase B = therapeutic education with tDCS for 4 weeks
Phase C = Cognitive remediation with tDCS for 4 weeks : Eight specific working memory remediation sessions will be carried out. These will be provided by a neuropsychologist. All cognitive remediation sessions will be individual, biweekly, lasting 1 hour 10 minutes for 4 weeks, for a total duration of 9 hours 20 minutes.
Phase D = follow-up
干预措施: cognitive remediation (Other)
5 weeks phase A arm
Phase A = therapeutic education. Randomised duration of this phase : 5 weeks. each therapeutic therapeutic education sessions last 90 minutes.
Phase B = therapeutic education with tDCS for 4 weeks
Phase C = Cognitive remediation with tDCS for 4 weeks : Eight specific working memory remediation sessions will be carried out. These will be provided by a neuropsychologist. All cognitive remediation sessions will be individual, biweekly, lasting 1 hour 10 minutes for 4 weeks, for a total duration of 9 hours 20 minutes.
Phase D = follow-up
干预措施: therapeutic education (Other)
5 weeks phase A arm
Phase A = therapeutic education. Randomised duration of this phase : 5 weeks. each therapeutic therapeutic education sessions last 90 minutes.
Phase B = therapeutic education with tDCS for 4 weeks
Phase C = Cognitive remediation with tDCS for 4 weeks : Eight specific working memory remediation sessions will be carried out. These will be provided by a neuropsychologist. All cognitive remediation sessions will be individual, biweekly, lasting 1 hour 10 minutes for 4 weeks, for a total duration of 9 hours 20 minutes.
Phase D = follow-up
干预措施: tDCS (Other)
5 weeks phase A arm
Phase A = therapeutic education. Randomised duration of this phase : 5 weeks. each therapeutic therapeutic education sessions last 90 minutes.
Phase B = therapeutic education with tDCS for 4 weeks
Phase C = Cognitive remediation with tDCS for 4 weeks : Eight specific working memory remediation sessions will be carried out. These will be provided by a neuropsychologist. All cognitive remediation sessions will be individual, biweekly, lasting 1 hour 10 minutes for 4 weeks, for a total duration of 9 hours 20 minutes.
Phase D = follow-up
干预措施: cognitive remediation (Other)
6 weeks phase A arm
Phase A = therapeutic education. Randomised duration of this phase : 6 weeks. each therapeutic therapeutic education sessions last 90 minutes.
Phase B = therapeutic education with tDCS for 4 weeks
Phase C = Cognitive remediation with tDCS for 4 weeks : Eight specific working memory remediation sessions will be carried out. These will be provided by a neuropsychologist. All cognitive remediation sessions will be individual, biweekly, lasting 1 hour 10 minutes for 4 weeks, for a total duration of 9 hours 20 minutes.
Phase D = follow-up
干预措施: therapeutic education (Other)
6 weeks phase A arm
Phase A = therapeutic education. Randomised duration of this phase : 6 weeks. each therapeutic therapeutic education sessions last 90 minutes.
Phase B = therapeutic education with tDCS for 4 weeks
Phase C = Cognitive remediation with tDCS for 4 weeks : Eight specific working memory remediation sessions will be carried out. These will be provided by a neuropsychologist. All cognitive remediation sessions will be individual, biweekly, lasting 1 hour 10 minutes for 4 weeks, for a total duration of 9 hours 20 minutes.
Phase D = follow-up
干预措施: tDCS (Other)
6 weeks phase A arm
Phase A = therapeutic education. Randomised duration of this phase : 6 weeks. each therapeutic therapeutic education sessions last 90 minutes.
Phase B = therapeutic education with tDCS for 4 weeks
Phase C = Cognitive remediation with tDCS for 4 weeks : Eight specific working memory remediation sessions will be carried out. These will be provided by a neuropsychologist. All cognitive remediation sessions will be individual, biweekly, lasting 1 hour 10 minutes for 4 weeks, for a total duration of 9 hours 20 minutes.
Phase D = follow-up
干预措施: cognitive remediation (Other)
4 weeks phase A arm
Phase A = Randomised duration of this phase : 4 weeks. each therapeutic therapeutic education sessions last 90 minutes.
Phase B = therapeutic education with tDCS for 4 weeks
Phase C = Cognitive remediation with tDCS for 4 weeks : Eight specific working memory remediation sessions will be carried out. These will be provided by a neuropsychologist. All cognitive remediation sessions will be individual, biweekly, lasting 1 hour 10 minutes for 4 weeks, for a total duration of 9 hours 20 minutes.
Phase D = follow-up
干预措施: tDCS (Other)
4 weeks phase A arm
Phase A = Randomised duration of this phase : 4 weeks. each therapeutic therapeutic education sessions last 90 minutes.
Phase B = therapeutic education with tDCS for 4 weeks
Phase C = Cognitive remediation with tDCS for 4 weeks : Eight specific working memory remediation sessions will be carried out. These will be provided by a neuropsychologist. All cognitive remediation sessions will be individual, biweekly, lasting 1 hour 10 minutes for 4 weeks, for a total duration of 9 hours 20 minutes.
Phase D = follow-up
干预措施: therapeutic education (Other)
结局指标
主要结局
Working memory performance
时间窗: 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.
次要结局
- Goal attainment(8 weeks after baseline)