Effects of Accelerated Bilateral Sequential Theta Burst Stimulation on Dual-task Cost, Depression, Cognition and Other Outcomes in Older Adults With Treatment-resistant Depression: A Randomized, Double-blind, Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in Dual-task Cost
研究概览
简要总结
The CogniTReaD study is a pilot clinical trial that will compare the effects of active accelerated bilateral sequential theta burst stimulation (absTBS) and sham or inactive treatment. The goal is to see if absTBS can help older adults with treatment-resistant depression (TRD) by looking at dual-task cost and mood, as well as other cognitive functions, anxiety levels, quality of life, and physical performance, while also checking for any treatment side effects. The study will recruit participants who will receive different study treatments in a specific order. The study will be double-blinded, meaning neither the participants nor the researchers will know who is receiving which treatment. The study will include people who are 50 years old or older and diagnosed with treatment-resistant depression with at least a moderate severity of depression. This study seeks to discover if absTBS can modify a dementia risk marker (i.e., dual-task cost and depression) in older patients with TRD, and to determine the effect size for larger investigations in the future.
详细描述
The CogniTReaD study is a two-arm, sham-controlled, double-blinded, treatment-sequenced, randomized clinical trial that will evaluate and explore the effects and safety of accelerated bilateral sequential theta burst stimulation (absTBS) compared to sham control in terms of improving dual-task cost, cognitive functions, depression, other outcomes (anxiety, health-related quality of life, activities of daily living, global impression, and other gait performance), and occurrence of adverse events (AE) measured at Week 2 (i.e., posttreatment acute effects) in older adults with treatment-resistant depression (TRD). We shall also evaluate the effects and safety of absTBS on improving dual-task cost, cognitive functions, depression and occurrence of AE in terms of AE occurrences measured at Week 6, Week 8, and Week 10 (i.e., posttreatment delayed effects) in older adults with TRD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
We shall perform a double-blinding system where the participants, study investigators, transcranial magnetic stimulation (TMS) technicians (those who operate and administer TMS procedures), and research assistants (outcome assessors) are masked to the assignment of the enrolled participants.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 50 years or older;
- •Mini International Neuropsychiatric Interview (MINI)-confirmed diagnosis of a non-psychotic major depressive disorder;
- •Currently in a major depressive episode with a score on HAMD-17 of 17 or more;
- •Insufficient response (i.e., failure to achieve remission) to at least two appropriate courses of antidepressant medications during the current depressive episode (i.e., meeting the criteria for TRD);
- •Participants taking or not taking any psychotropic medication/s. If the eligible participant is on any psychotropic medications, the participant should have taken the medication/s at a stable dose for at least 1 week before the start of study intervention treatment and be willing to remain on a stable dose throughout the study follow-up;
- •Passing the TMS safety screen; and
- •Those who have the capacity to provide consent and who voluntary consent to participate in the study.
排除标准
- •Those with MINI-confirmed active substance use disorder within the last 3 months;
- •Those with lifetime MINI-confirmed diagnosis of bipolar I disorder, delusional disorder, schizophrenia, schizoaffective disorder, or schizophreniform disorder;
- •Those with major unstable medical comorbidities (i.e., rapidly deteriorating medical/neurological conditions that poses a significant risk to a person's life);
- •Those with a diagnosis of dementia confirmed using the Global Clinical Dementia Rating (CDR) with a score greater than or equal to
- •Those with significant neurological conditions, such as those with any disease process associated with increased intracranial pressure, space-occupying intracranial lesion, history of epilepsy/seizure except those induced by ECT, or febrile seizure of infancy or a single occurrence of seizure associated with a known drug, cerebral aneurysm, or major head trauma resulting to loss of consciousness more than 5 minutes;
- •Those with cardiac pacemaker or implanted mediation pump;
- •Those with intracranial implants/hardwares, including but not limited to aneurysm clips, shunts, stimulators, cochlear implants, electrodes, or any other metal material inside or near the head (excluding the mouth) that cannot be safely removed;
- •Those who are taking more than 2 mg of Lorazepam daily (or equivalent) or taking any dose of an anticonvulsant that may potentially hamper rTMS efficacy;
- •Those who are unable to express and understand using the English language; and
- •Individuals who are pregnant or who are likely pregnant.
研究组 & 干预措施
Sham-absTBS treatment sequence arm
In the sham-absTBS arm, the blinded sham treatment shall be administered at Week 1. The blinded active absTBS treatment shall be given at Week 3.
干预措施: active accelerated bilateral sequential theta burst stimulation and sham treatment (Device)
absTBS-sham treatment sequence arm
Those assigned to the accelerated bilateral sequential theta burst stimulation (absTBS)-sham arm shall receive the blinded active absTBS treatment at Week 1. At Week 3, they shall receive the blinded sham treatment.
干预措施: active accelerated bilateral sequential theta burst stimulation and sham treatment (Device)
结局指标
主要结局
Change in Dual-task Cost
时间窗: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Change in Hamilton Depression Rating Scale 17 (HAMD-17) score
时间窗: Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10
Adverse events (AE)
时间窗: Week 1, Week 2, Week 3, Week 6, Week 8, and Week 10
An AE is defined as any untoward medical occurrence associated with any of the study interventions (active absTBS or sham) whether or not considered related to the study intervention. A serious AE to any serious and unforeseen occurrence related or possibly related to the participation in the study that can lead to hospitalization, disability, or death.
次要结局
- Change in Patient Health Questionnaire-9 (PHQ-9) score(Week 0 (baseline), Week 2)
- Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) plus modalities score(Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10)
- Change in Colour Word Interference Test (CWIT) score(Week 0 (baseline), Week 2)
- Change in Geriatric Depression Scale 30 (GDS-30) score(Week 0 (baseline), Week 2)
- Change in Category Verbal Fluency (CVF) score(Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10)
- Change in Lawton-Brody Instrumental Activities of Daily Living (LB-IADL) score(Week 0 (baseline), Week 2)
- Change in Digit Symbol Substitution Test (DSST) score(Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10)
- Change in Generalized Anxiety Disorder 7 (GAD-7) score(Week 0 (baseline), Week 2)
- Change in Alzheimer Disease Cooperative Study - Activities of Daily Living inventory (ADCS-ADL) score(Week 0 (baseline), Week 2)
- Change in Clinical Global Impression (CGI) score(Week 0 (baseline), Week 2)
- Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) score(Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10)
- Change in Trail Making A (TMT-A) score(Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10)
- Change in Trail Making B (TMT-B) score(Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10)
- Change in Digit Span Forward (DSF) score(Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10)
- Change in Digit Span Backward (DSB) score(Week 0 (baseline), Week 2, Week 6, Week 8, and Week 10)
- Change in Montreal Cognitive Assessment (MoCA) score(Week 0 (baseline), Week 2)
- Change in Short Form 36 (SF-36) score(Week 0 (baseline), Week 2)
- Change in Short Physical Performance Battery (SPPB) score(Week 0 (baseline), Week 2)
- Change in Timed Up & Go (TUG) score(Week 0 (baseline), Week 2)