Feasibility, Tolerability, and Preliminary Efficacy for Non-Invasive Neuromodulation of the Anterior Cingulate Cortex for Depression (NACC-D) in Older Adults Using Deep Transcranial Magnetic Stimulation With an Accelerated Intermittent Theta Burst Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Percentage of scheduled treatment sessions that are attended by study participants
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 can reduce depressive symptoms in older adults (ages 60-85) with Major Depressive Disorder (MDD) who have not tolerated or responded to antidepressant medications. The study will evaluate whether accelerated dTMS administered over 5 consecutive days is safe and well-tolerated in this population, and whether it produces greater reductions in depressive symptoms compared to placebo stimulation.
详细描述
This study will investigate the effects of an accelerated intermittent theta burst protocol (a-iTBS) using the H7 deep Transcranial Magnetic Stimulation (dTMS) coil to target the anterior cingulate cortex (ACC) in older adults (aged 60-85) with Major Depressive Disorder (MDD). Twenty-four older adults with treatment-resistant MDD will participate in a single site, double-blind, randomized sham-controlled trial using an accelerated schedule of multiple dTMS sessions per day for 5 consecutive days. The primary goal of the study is to establish the feasibility of an accelerated aiTBS protocol of the ACC in older adults with treatment resistant depression, 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
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are between 60- 85 years old (on the day of randomization)
- •have been diagnosed with DSM5 Major Depressive Disorder, with the current episode longer than 4 weeks but less than 5 years
- •did not respond to/did not tolerate, or failed to achieve remission with at least one antidepressant trial of 8 week minimum duration
- •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 your 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
- •require daily doses of benzodiazepines or hypnotics within two weeks of randomization
结局指标
主要结局
Percentage of scheduled treatment sessions that are attended by study participants
时间窗: 6 weeks
Participant-reported comfort and feasibility based on the frequency and type of adverse events as measured using the Adverse Events Questionnaire (AEQ)
时间窗: 6 weeks
Severity of symptoms is rated from 1 to 4, with 1 being absent and 4 being severe. Whether symptoms are perceived to be relatedTMS treatment are rated from 1 to 5, with 1 being no and 5 being definitely.
The number of participants who have prematurely withdraw and reasons for withdrawal
时间窗: 6 weeks
The change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) scores following the final treatment on day 5 (i.e., after 5 days of H7-coil a-iTBS) in the treatment group compared to the sham group.
时间窗: 1 week
An effect size (Cohen's d) of 0.5 will be considered a minimally important effective size. The MADRS ranges from 0-60, with a greater score indicating greater depressive symptoms.
Percentage of scheduled treatment sessions that are attended by study participants
时间窗: 6 weeks
Participant-reported comfort and feasibility based on the frequency and type of adverse events as measured using the Adverse Events Questionnaire (AEQ)
时间窗: 6 weeks
Severity of symptoms is rated from 1 to 4, with 1 being absent and 4 being severe. Whether symptoms are perceived to be relatedTMS treatment are rated from 1 to 5, with 1 being no and 5 being definitely.
The number of participants who have prematurely withdraw and reasons for withdrawal
时间窗: 6 weeks
The change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) scores following the final treatment on day 5 (i.e., after 5 days of H7-coil a-iTBS) in the treatment group compared to the sham group.
时间窗: 1 week
An effect size (Cohen's d) of 0.5 will be considered a minimally important effective size. The MADRS ranges from 0-60, with a greater score indicating greater depressive symptoms.
次要结局
- Response rates compared between treatment groups following 5 days of treatment, where the response rate refers to the percentage of patients who responded to a-ITBS treatment and response is defined as a ≥50% reduction in MADRS score from baseline(6 weeks)
- Remission rates compared between treatment groups following 5 days of treatment, where the remission rate is defined as MADRS score <10(6 weeks)
- The change in baseline slow wave and resting state activity as measured with electroencephalography (EEG) following 5 days of treatment and at 1-month follow-up(6 weeks)
- The change in functional connectivity within the default mode and central autonomic networks on Magnetic Resonance Imaging (MRI)(1 week)
- The change in slow wave activity in the posterior default mode network (posterior cingulate cortex) as measured with MEG(1 week)
- The change in baseline cognitive tests following 5 days of treatment and at 1-month follow-up (cognitive domains tested include executive function and memory),(6 weeks)
- The change in baseline emotional processing as measured with an Affective Simon task following a single TMS session, after 5 days of treatment and at 1-month follow-up(6 weeks)
- Response rates compared between treatment groups following 5 days of treatment, where the response rate refers to the percentage of patients who responded to a-ITBS treatment and response is defined as a ≥50% reduction in MADRS score from baseline(6 weeks)
- Remission rates compared between treatment groups following 5 days of treatment, where the remission rate is defined as MADRS score <10(6 weeks)
- The change in baseline slow wave and resting state activity as measured with electroencephalography (EEG) following 5 days of treatment and at 1-month follow-up(6 weeks)
- The change in functional connectivity within the default mode and central autonomic networks on Magnetic Resonance Imaging (MRI)(1 week)
- The change in slow wave activity in the posterior default mode network (posterior cingulate cortex) as measured with MEG(1 week)
- The change in baseline cognitive tests following 5 days of treatment and at 1-month follow-up (cognitive domains tested include executive function and memory),(6 weeks)
- The change in baseline resting state heart rate variability (HRV) following a single TMS session and after 5 days of treatment(1 week)
- The change in baseline emotional processing as measured with an Affective Simon task following a single TMS session, after 5 days of treatment and at 1-month follow-up(6 weeks)
研究者
Linda Mah, MD
Clinician Scientist
Rotman Research Institute at Baycrest