Effects of t-DCS Combined With Concurrent Cognitive Training on Apathy in Elderly Subjects With Minor Neurocognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Apathy Inventory (Robert et al., 2002), clinician version
研究概览
简要总结
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique using a low intensity electric current to modify cortical excitability. Apathy is a pervasive neuropsychiatric symptom characterized by a reduction in goal-directed behavior and activity that persists over time and causes identifiable functional impairment. The aim of this study is to evaluate the effects of repeated sessions of tDCS combined with simultaneous cognitive training on apathy in older people with minor neurocognitive disorders.
详细描述
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique using a low intensity electric current to modify cortical excitability. There is growing interest for tDCS for psychiatric illnesses, notably for depression.
Apathy is a pervasive neuropsychiatric symptom characterized by a reduction in goal-directed behavior and activity that persists over time and causes identifiable functional impairment. tDCS could be a promising new area for non-pharmacological treatment of apathy.
The aim of this study is to evaluate the effects of repeated sessions of tDCS combined with simultaneous cognitive training on apathy in older people with minor neurocognitive disorders. For this, 30 apathetic subjects with minor neurocognitive disorders will be included and randomized between two groups. The intervention group will follow sessions of tDCS combined with a simultaneous cognitive training on tablet. The control group will follow cognitive training with a combined sham tDCS. Intervention will last for 4-week with 3 sessions per week (12 sessions). Stimulation will be performed with Startim 20 (Neuroelectrics®) which is approved by the European Union as a Class IIa medical device and meeting European safety standards. Stimulation will last for 20 minutes and the dorsolateral prefrontal cortex (F3) will be targeted. For the intervention group, the electric current will be 2mA. Assessments will be done at baseline, just after the end of intervention and 3 months after intervention. Apathy, daily functional motor behaviors, cognitive functions and fatigue will be assessed with clinician assessment, self-administered questionnaires, ambulatory actigraphy and cognitive tests. The assessments and the intervention will be done by different people. Study will be a double-blind randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years
- •Subject consulting in one of the investigating centers
- •Clinical diagnosis of Minor Neurocognitive Disorder according to DSM 5 criteria (APA, 2013)
- •Apathetic syndrome defined according to the Diagnostic Criteria for Apathy (Miller & al., 2021)
- •Subject who can read and write French
- •Subjects who are beneficiaries of a social security plan
- •Signature of free and informed consent
排除标准
- •Current clinical diagnosis of a depressive episode characterized by DSM 5 criteria (APA, 2013)
- •Known diagnosis of schizophrenia, bipolar disorder, substance abuse or dependence
- •Significant sensory or motor impairment
- •Subject under guardianship, conservatorship, or conservatorship
- •Active smoking or smoking cessation of less than one year
- •Contraindications to the practice of tDCS: history of intracranial hypertension, neurosurgery, metallic implant at the cephalic level, pacemaker
- •Unbalanced epilepsy
- •Severe somatic disease not stabilized
- •Previous use of tDCS (problem of maintaining the integrity of the blinding procedure)
- •Scalp skin disease
- •Concurrent participation in another drug research study or any other study that may interfere with study results
研究组 & 干预措施
tDCS combined with simultaneous cognitive training
干预措施: tDCS (Other)
cognitive training with a combined sham tDCS
干预措施: SHAM tDCS (Other)
结局指标
主要结局
Apathy Inventory (Robert et al., 2002), clinician version
时间窗: Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
The Apathy Inventory scored from 0 (No problem) to 4 (major problem) the 3 dimensions of apathy: the emotional blunting, the loss of initiative and the loss of interest. A higher total score indicates a greater severity.
次要结局
- Assessment of fatigue with Multidimensional fatigue inventory (MFI)(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of neuropsychiatric symptoms(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of the global cognitive functioning(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of cognitive functions with FAB(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of episodic memory(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of attention and mental flexibilty(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of working memory(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of fatigue with 15-sec Sustained maximal handgrip contraction(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of verbal fluency(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of language(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of daily physical activity(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of tDCS adverse effects questionnaire(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of verbal fluency(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of language(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of working memory(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of neuropsychiatric symptoms(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of the global cognitive functioning(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of cognitive functions with FAB(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of episodic memory(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of attention and mental flexibilty(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of fatigue with Multidimensional fatigue inventory (MFI)(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of fatigue with 15-sec Sustained maximal handgrip contraction(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of daily physical activity(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))
- Assessment of tDCS adverse effects questionnaire(Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention))