NCT06581458尚未招募不适用
Home Transcranial Direct-Current Stimulation for Motoric Cognitive Risk Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 主要终点
- Accuracy in Serial Subtractions Task
研究概览
简要总结
- To examine the effect of a two-week tDCS intervention of 3 months of continued tDCS intervention versus 3 months of receiving a placebo treatment (dummy). On the costs of performing an action task (dual task cost) walking speed, cognitive measures and motor function.
- To examine whether the effects of tDCS build up over time by creating a delayed start mechanism in the intervention (delayed-start design)
- Examining mechanical and neuroplastic effects of tDCS intervention
- To examine the response to tDCS over time
详细描述
- The study aims to investigate the mechanical and neuroplastic effects of a tDCS intervention.
- The intervention consists of an initial two-week period of tDCS application, followed by three months of continued tDCS treatment.
- A placebo group will receive a dummy treatment for three months to compare the outcomes.
- The study will measure various parameters including the costs of performing an action task (dual task cost), walking speed, cognitive measures, and motor function.
- A delayed-start design will be used to determine if the effects of tDCS build up over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65-90
- •Cognitive complaints
- •A positive answer to the question "Do you feel you have more problems than most people?"
- •A negative answer to the question "Is your thinking as clear and sharp as it was before?"
- •Slow walking - one standard deviation below the average for age and gender (under age 75: men less than 101.9 cm/s, women less than 97.4 cm/s. Over or equal to age 75: men less than 85.3 s) m/s women less than 76.7 cm/s)
- •No significant disability
- •There is the ability to walk without support on a walking carpet
- •A result below 9 in the Functional Activities Questionnaire index
- •Identification as qualified
- •Identification as willing and able to operate a tDCS device or have a partner who is able to operate the device during home use. According to the criteria:
- •Inclusion: selected by the patient, over the age of 21, with basic computer skills and available throughout the study period
- •Exclusion: MOCA score lower than or equal to
- •Presents insufficient understanding, poor vision, severe joint problems in the hands, deformity pain or other conditions that may interfere with the successful operation of the tDCS
- •Has access to a reliable wireless internet network (WiFi) at the patient's home
排除标准
- •Less than eight years of study
- •According to the clinical definition clinical dementia rationing (CDR) score 1 or higher
- •Previous diagnosis
- •Performance in the range indicating dementia in the neuropsychological test bettery (lower than 2 standard deviations below the age- and sex-matched average)
- •IQ is low or equal to 85 in the WTAR test. without a background of mental disability
- •Current diagnosis of major psychiatric disorders (schizophrenia, bipolar, major depression)
- •Evidence of moderate to severe symptoms of depression. A score high or equal to 9 on the 15 item geriatric depression scale
- •History of head injury that led to prolonged loss of consciousness
- •History of palpitations of unknown origin that may indicate convulsions
- •History of convulsions, diagnosis of epilepsy in the patient or in most of the first degree family. Except for a case of a single seizure of benign etiology determined by a neurologist
- •Hospitalization during the last three months following an acute illness or musculoskeletal injury with a significant impact on walking or stability
- •An unbalanced medical condition that can worsen following convulsive stimulation (cardiac malformation, cardiac arrhythmias, asthma, etc.)
- •Substance use disorders during the last six months
- •A wig or hair design that prevents contact of the electrodes with the scalp or interferes with the administration of the stimulation
- •Chronic vertigo
- •A cardiac event within the last six months
- •Active cancer treated with chemotherapy or radiation
- •blindness
- •Visual hallucinations (according to history or self-report)
- •There are contraindications for MRI or tDCS as defined by the International Federation for Clinical Neurophysiology
- •Includes unprovoked convulsions during the last 2 years
- •Danger of finding ferromagnetic objects in the body, self-reporting of medical implants in the body (DBS, deep brain stimulation, drug delivery pump, cochlear implant, pacemaker)
- •Inventions active dermatological condition
- •History of behavior disorders in REM sleep, sometimes an early sign of Parkinson's disease
- •Medications and medical history will be examined by a clinician and a decision regarding entry into the study will be based on medical history, current medication dosage and medication change before or during the treatment as well as combination with other active CNS medications.
研究组 & 干预措施
tDCS immediate intervention group
Experimental
Participants in the tDCS Immediate Intervention Group will receive an initial two-week period of transcranial Direct Current Stimulation (tDCS) treatment. This will be followed by three months of continued tDCS intervention.
干预措施: tDCS (Drug)
Late intervention group (tDCS+ sham)
Sham Comparator
Participants in the Late Intervention Group will first receive a placebo (sham) treatment for three months. This will be followed by a two-week period of active transcranial Direct Current Stimulation (tDCS) treatment, then three months of continued tDCS intervention.
干预措施: tDCS (Drug)
结局指标
主要结局
Accuracy in Serial Subtractions Task
时间窗: 45-second
articipants will perform serial subtractions from a random 3-digit number between 200 and 999. Accuracy will be measured as the percentage of correct subtractions.
Usual walk
时间窗: 45-second
fNIRS with walking trial 20m indoor course with 180-degree turns at each end and an instrumented gait mat in the middle.
Walk with the cognitive task (DT)
时间窗: 45-second
fNIRS with walking trial 20m indoor course with 180-degree turns at each end and an instrumented gait mat in the middle.
次要结局
- Mobility - SPPB (Short Physical Performance Battery)(9 months)
- Mobility - 4 m Gait Test(9 months)
- Mobility - Falls Efficacy Scale-International (FES-I)(9 months)
- Mobility - Habitual Physical Activity and Real-World Gait(9 months)
- Mood- Geriatric Depression Scale (GDS(9 months)
- Mood- SF-36 (Short Form Health Survey)(9 months)
- anxiety- Geriatric Anxiety Inventory - Short Form (GAI-SF)(9 months)
- apathy(9 months)
- Functional Activity Questionnaire(9 months)
- Cognitive Function - Motor Screening Task(9 months)
- Cognitive Function - Reaction Time(9 months)
- cognitive Function(9 months)
- Cognitive Function - Paired Associates Learning(9 months)
- Cognitive Function - Spatial Working Memory(9 months)
- Cognitive Function - Pattern Recognition Memory(9 months)
- Cognitive Function - Delayed Matching to Sample(9 months)
- Cognitive Function - Rapid Visual Information Processing(9 months)
- Cognitive Function - Montreal Cognitive Assessment (MoCA)(9 months)
- Cognitive Function - Rey Auditory Verbal Learning Test (RAVLT)(9 months)
- Cognitive Function - Category and Phonemic Fluency Tests(9 months)
- Height(9 months)
- Weight(9 months)
- Medical History(9 months)
- Blood Pressure(9 months)
研究者
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