NCT01464515Unknown1 期
Feasibility Study in Order to Test the Efficiency of Deep TMS on Patient With MCI
适应症
试验速览
- 阶段
- 1 期
- 发起方
- Brainsway
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mindstreams
研究概览
简要总结
This is a first feasibility study in order to test if deep Transcranial Magnetic Stimulation (TMS) treatment with high frequency (10Hz) will improve the symptoms of patient MCI (Mild Cognitive impairment). The hypothesis of the study is that high frequency treatment with deep TMS will improve the daily functioning of patients who suffers from MCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 50-80 years of age.
- •Self reporting of the patient about memory deterioration, without any damage of daily lify functioning.
- •Scored of one standard deviation below the average (according to standardization of age and years of schooling) in the memory index and Mindstream test, without any major damage of other cognitive function)
- •score >= 24 in MMSE (Mini Mental State Examination) test.
- •Preserved Cognitive and executive functioning, without dementia according to DSM -IV
- •Lack of other reason for memory deterioration like acute affect disorder or other neurological disorders, according to the doctor diagnosis.
- •Score of maximum 0.5 in the Clinical Dementia Rating. in this test the score of the memory index will be 0.5 or 1, and not more then 1 point in two other index of this test.
- •Capable and willing to provide informed consent.
排除标准
- •Any other Axis I diagnosis as the primary diagnosis
- •Any medications that can cause a risk of seizure. for instance, anti psychotic medication, high dosage of anti depression medication
- •History of non tolerance for TMS treatment
- •Diagnosis of Severe personality disorder according to DSM-IV
- •current suicidal tendency
- •Uncontrolled hypertension
- •History of epilepsy, seizure, or heat convulsion
- •History of epilepsy or seizure in first degree relatives
- •History of head injury or stroke
- •History of metal implants in the head (except dental fillings)
- •History of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemaker, cochlear implants, use of neurostimulators, or any medical pumps
- •History of drug or alcohol abuse
- •Inadequate communication with examiner
- •Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it
- •Inability to sign a consent form
- •Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse
结局指标
主要结局
Mindstreams
时间窗: the test will be assessed on visit 17 which means 4 month from baseline
Mindstreams test is designed to test the I.Q change of the patients from baseline
次要结局
- CDR - Clinical Dementia Rating(the test will be assessed on visit 17 which means 4 month from baseline)
研究者
研究点 (1)
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