EFFECTS of RTMS TREATMENT on SOCIAL COGNITION DYSFUNCTIONS in MILD COGNITIVE IMPAIRMENT: an PROSPECTIVE, DOUBLE-BINDING, RANDOMIZED, SINGLE CENTRE, EXPLORATIVE STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Comparison of Deceptive Box Task score
研究概览
简要总结
Social cognitive abilities are impaired in around 17% of subjects with mild cognitive impairment (MCI), and might not reflect upon functional status. Compared to healthy controls, MCI showed impairments in theory of mind (ToM) and facial emotion recognition. Moreover, in amnesic MCI patients, reduced ToM ability appears to be correlated with worse performances at several cognitive performances. These findings, in agreement with previous evidence, confirm that impaired social cognition might occur prior to dementia: typically elderly start to show impairment in the complex ToM levels, which is found also in MCI patients and proceeds further in AD patients. Thus, the treatment of these aspects has the potential to influence the trajectory of neurodegeneration. In the last decade, it has been increasingly evident the effectiveness of active stimulation of brain regions with repetitive transcranial magnetic stimulation (rTMS), to improve cognitive and functional performances in patients with dementia.
On the other hand, brain imaging techniques and TMS stimulations have identified two main areas responsible for human social cognition- the medial prefrontal cortex (MPFC) and the right temporo-parietal junction (RTPJ).
In this project, we hypothesized that an improvement of social cognition skills may be obtained in MCI patients by using the rTMS on two main areas responsible for human social cognition- the medial prefrontal cortex (MPFC) and the right temporoparietal junction (RTPJ). Moreover, it expects that rTMS treatment may also contribute to improving cognitive abilities and neuropsychiatric aspects partially modulated by the same networks stimulated.
详细描述
This is a prospective, double-binding, cross-sectional, randomized, sham-controlled, and single-center project aimed to investigate the effect of rTMS treatment of social cognition abilities in MCI subjects at 2 and 4 weeks, and after 8 weeks from baseline.
All patients will be recruited at Clinical Neuroscience Institute, Department of Neurology, Regional Civic Hospital, Lugan; Department of Geriatric Italian Hospital Viganello; and Department of Geriatric, Beata Vergine Hospital Mendrisio; Southern Switzerland, Switzerland.
Primary objective:
- To investigate whether the application of high-frequency rTMS, for 2 or 4 weeks, to the RPTJ and MPFC resulted in social cognitive improvements.
Secondary objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 50 to 85 years old, inclusive, at the time of informed consent;
- •Must have at least 5 years of education or work experience to exclude mental deficits other than MCI;
- •Must meet Petersen's criteria for mild cognitive impairment, and must have:
- •Clinical dementia rating global score of 0.5;
- •Mini-Mental State Examination score between 24 and 30;
- •Must have a score ≥ 26.5 at Token test to ensure that subjects have the ability to understand the instructions and procedures;
- •Must have a score < 29 at Beck Depression Inventory to exclude major depression that could compromise the patient's ability to engage in the study;
- •Apart from a clinical diagnosis of MCI, the subject must be in good health;
- •Must be on stable dose of antidepressant (if applicable) for at least 2 months prior to the enrolment.
排除标准
- •Any uncontrolled medical or neurological/neurodegenerative condition (other than MCI);
- •Clinical significant unstable psychiatric illness requiring treatment with neuroleptic;
- •Transient ischemic attack, stroke, or any unexplained loss of consciousness or severe ongoing stressor within 1 year prior to screening;
- •History of seizure within10 years prior to screening;
- •Recent history of alcohol or substance abuse or use of cannabinoids;
- •Any other medical conditions that are not stable or controlled, or could affect the subject's safety or interfere with the study assessments and treatment;
- •Contraindication to having TMS treatment;
- •Inability to understand the purpose of the study or to comply with study requirements.
结局指标
主要结局
Comparison of Deceptive Box Task score
时间窗: Week 4
(5 items). Minimum value=0, maximum value=5. A higher score means a better outcome.
Comparison of Look-prediction/say-prediction test score
时间窗: Week 2
(5 items). Minimum value=0, maximum value=5. A higher score means a better outcome.
Comparison of Empathy Quotient score
时间窗: Week 4
(60 items). Minimum value=0, maximum value=80. A higher score means a better outcome.
Comparison of Ekman 60 test score
时间窗: Week 4
(60 b/w pictures). Minimum value=0, maximum value=60. Higher score means a better outcome.
Comparison of Look-prediction/say-prediction test
时间窗: Week 4
(5 items). Minimum value=0, maximum value=5. A higher score means a better outcome.
Comparison of Frontal Behavioral Inventory score
时间窗: Week 4
(24 items). Minimum value=0, maximum value=69. Higher score means a worse outcome.
次要结局
- Changes from baseline in Empathy Quotient scale(Week 12)
- Changes from baseline in Deceptive Box Task Test.(Week 12)
- Changes from baseline in Look/say Test(Week 12)
- Comparison of Euroquol-5 dimensions score(athrough study completion, an average of 12 weeks)
- Changes from baseline in Ekman 60 Test(Week 12)
- Changes from baseline in Frontal Behavioral Inventory(Week 12)
- Comparison Montreal Cognitive Assessment(through study completion, an average of 12 weeks)
- Comparison of Geriatric Depression Scale score(through study completion, an average of 12 weeks)
研究者
Leonardo Sacco
Principal Investigator
Ospedale Regionale di Lugano