Effect of Accelerated Neuromodulation of Anterior Cingulate Cortex to Enhance Cognition in Older Adults With Mild Memory Problems
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Incidence and type of of adverse events experienced during treatment (participant-reported tolerability) based on the Adverse Events Questionnaire (AEQ)
研究概览
简要总结
The goal of this clinical trial is to test whether an accelerated deep Transcranial Magnetic Stimulation (dTMS) protocol in combination with cognitive training can improve cognitive abilities in older adults with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI). The study will look at whether it is safe and tolerable to use accelerated dTMS to enhance the benefits of cognitive training in older adults, and will also gather early information on the effects of accelerated dTMS on memory and other cognitive abilities.
详细描述
This study will examine the effects of combining cognitive remediation with accelerated intermittent theta burst stimulation (a-iTBS) using the H7 deep Transcranial Magnetic Stimulation (dTMS) coil to target the anterior cingulate cortex (ACC) in older adults aged 55-85 with MCI or SCD. Thirty older adults will participate in a single site, double-blind, randomized sham-controlled trial using an accelerated schedule of multiple dTMS sessions per day for 2-5 consecutive days, followed by 6 weeks of online cognitive remediation for both sham and dTMS interventions. The primary goal of the study is to establish the feasibility of an a-iTBS protocol combined with cognitive training in older adults with Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD) and to obtain preliminary evidence of treatment efficacy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •55 - 85 years of age (on the day of randomization)
- •are male or post-menopausal female
- •have a diagnosis of mild cognitive impairment (MCI) based on Montreal Cognitive Assessment score < 26 or where available, results from clinical neuropsychological assessment, OR subjective memory concerns and first degree relative, living or deceased, with a probable or confirmed diagnosis of AD
- •score 24 or higher on the Mini Mental State Examination (MMSE)
- •are willing to provide informed consent
- •are able to follow the treatment schedule
- •are stable on medications for 2 months and are not expected to change medication during the entire study period (if they are taking medications)
- •have a satisfactory safety screening questionnaire for TMS
排除标准
- •have a metal plate in their head(such as an ear implant, implanted brain stimulators, aneurysm clips). Dental devices and implants that are non-magnetic are safe.
- •have known increased pressure or a history of increased pressure in their brain, which may increase their risk for having seizures
- •have a cardiac pacemaker
- •have an implanted medication pump
- •have a central venous line
- •have a history of any psychotic disorder, bipolar disorder, eating disorder, obsessive compulsive disorder, post-traumatic stress disorder, or dementia
- •have a history of substance abuse in the last 6 months
- •have a history of stroke or other brain lesions
- •have a personal history of epilepsy
- •have a family history of epilepsy
- •are a pregnant or breast-feeding woman
- •have a history of abnormal MRI of the brain
- •have untreated hypo- or hyper-thyroidism
- •have unstable medical condition(s)
- •have any other known contraindications to TMS
- •are on unstable doses of any psychotropic medication such as antidepressants, antipsychotic, mood stabilizers or memory enhancing medications
- •regularly use benzodiazepines or other hypnotics within 2 weeks of randomization
研究组 & 干预措施
20-40 sessions of iTBS dTMS and 6-weeks of online cognitive remediation
干预措施: Active Brainsway H7-Coil Deep TMS System (Device)
20-40 sessions of sham stimulation and 6-weeks of online cognitive remediation
干预措施: Sham Brainsway H1-Coil Deep TMS System (Device)
结局指标
主要结局
Incidence and type of of adverse events experienced during treatment (participant-reported tolerability) based on the Adverse Events Questionnaire (AEQ)
时间窗: 9 weeks
The AEQ asks about symptoms related immediately after TMS administration where patients rate symptom severity from 1 (absent) to 4 (severe) and whether they believe it is related to TMS from 1 (no) to 5 (definitely).
The number of participants who prematurely withdraw and reasons for withdrawal
时间窗: 9 weeks
Percentage of dTMS sessions attended by participants
时间窗: 1 week
Change from baseline memory scores on computerized neuropsychological battery following the final session on day 5
时间窗: 9 weeks
Memory score from memory tests in the neuropsychological battery at baseline will be compared to after 5 days of TMS and after 6 weeks of cognitive training the active intervention group compared to the sham. A higher memory score indicates better memory performance. An effect size (Cohen's d) of 0.5 will be considered a minimally important effect size.
Change from baseline executive function scores on computerized neuropsychological battery following final session on day 5
时间窗: 9 weeks
Executive function scores from tests on the neuropsychological battery will be compared from baseline to after days of dTMS and after 6 weeks of cognitive training in the active intervention group compared to sham. A higher score on these tests indicate greater executive functioning. An effect size (Cohen's d) of 0.5 will be considered a minimally important effect size.
Percentage of dTMS sessions attended by participants
时间窗: 1 week
Incidence and type of of adverse events experienced during treatment (participant-reported tolerability) based on the Adverse Events Questionnaire (AEQ)
时间窗: 9 weeks
The AEQ asks about symptoms related immediately after TMS administration where patients rate symptom severity from 1 (absent) to 4 (severe) and whether they believe it is related to TMS from 1 (no) to 5 (definitely).
The number of participants who prematurely withdraw and reasons for withdrawal
时间窗: 9 weeks
Change from baseline memory scores on computerized neuropsychological battery following the final session on day 5
时间窗: 9 weeks
Memory score from memory tests in the neuropsychological battery at baseline will be compared to after 5 days of TMS and after 6 weeks of cognitive training the active intervention group compared to the sham. A higher memory score indicates better memory performance. An effect size (Cohen's d) of 0.5 will be considered a minimally important effect size.
Change from baseline executive function scores on computerized neuropsychological battery following final session on day 5
时间窗: 9 weeks
Executive function scores from tests on the neuropsychological battery will be compared from baseline to after days of dTMS and after 6 weeks of cognitive training in the active intervention group compared to sham. A higher score on these tests indicate greater executive functioning. An effect size (Cohen's d) of 0.5 will be considered a minimally important effect size.
次要结局
- The change in baseline in scores on the Geriatric Anxiety Inventory (GAI) following 5 days of dTMS(1 week)
- The change in resting state activity as measured with electroencephalography (EEG) following 5 days of dTMS(1 week)
- The change in slow wave activity in the posterior default mode network (posterior cingulate cortex) as measured with MEG following 5 days of dTMS(1 week)
- The change in functional connectivity within the default mode network based on Magnetic Resonance Imaging (MRI) following 5 days of dTMS(1 week)
- The change in baseline in scores on the Geriatric Depression Scale (GDS)(1 week)
- The change in baseline slow wave as measured with electroencephalography (EEG) following 5 days of dTMS(1 week)
- The change in baseline in scores on the Geriatric Anxiety Inventory (GAI) following 5 days of dTMS(1 week)
- The change in resting state activity as measured with electroencephalography (EEG) following 5 days of dTMS(1 week)
- The change in slow wave activity in the posterior default mode network (posterior cingulate cortex) as measured with MEG following 5 days of dTMS(1 week)
- The change in functional connectivity within the default mode network based on Magnetic Resonance Imaging (MRI) following 5 days of dTMS(1 week)
- The change in baseline in scores on the Geriatric Depression Scale (GDS)(1 week)
- The change in baseline slow wave as measured with electroencephalography (EEG) following 5 days of dTMS(1 week)
研究者
Linda Mah, MD
Clinician Scientist
Rotman Research Institute at Baycrest