Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Affective Symptoms in Patients Suffering From Dementia: a Randomised Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Cornell Scale for Depression in Dementia (CSDD)
研究概览
简要总结
This is a monocentric prospective, randomized, double-blind placebo-controlled study. It is designed to evaluate the superiority of the rTMS over sham treatment of depressive symptoms in the context of dementia. It is aimed at a population ≥ 65 years old, with affective BPSD. We wish to recruit 44 participants, with an estimated rate of potential drop out of 20%. Patients will be randomly assigned to the sham or rTMS group. The sham stimulation reproduces the procedure in all the steps, has the same duration and differs exclusively by the device setting. After inclusion, both groups will receive 15 sessions distributed over 5 days a week for 3 weeks
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent as documented by their and their proxy's signature (Appendix Informed Consent Form)
- •Consent for MRI
- •Age ≥ 65 years
- •Clinical dementia Rating Scale (CDR) ≥ 1
- •NPI-Q Σ (*Anxiety + * Apathy/Indifference + * Dysphoria/Depression) ≥ 3
- •Cornell Scale for Depression in Dementia (CSDD) ≥ 10
排除标准
- •History of schizophrenia, bipolar disorder, schizoaffective disorder
- •History of macroscopic stroke.
- •Unstable somatic pathologies
- •Insufficient collaboration for the rTMS procedure
- •Drug freeness or drug adjustment as clinically required is not an exclusion criterion.
- •The proxy refuses to give consent in case of lack of capacity, or in any case where the participant expresses a wish not to participate/continue in the study.
- •Any contraindications to performing an MRI (cf CRF) and rTMS (aneurysm clips or coils, stents in the neck or brain, deep brain stimulators, electrodes to monitor brain activity, metal implants in the ears and eyes, facial tattoos with metallic or magnetically sensitive ink) procedure
研究组 & 干预措施
Active
Magnetic stimulus intensity of 80% of the motor threshold applied at the frequency of 20 Hz over the left DLPFC with a total number of pulses of 1200 / treatment session for a total of 5 sessions /week for 3 consecutive weeks
干预措施: rTMS (Device)
Sham
Sham procedure implies the use of a "sham" coil of exactly the same dimension and appearance as the one used for the effective treatment. This sham coil is made for research purposes by the producing company and used in accordance with the instructions for use, which explicitly mention it (cf. instruction manual page 34: Stimulation Coil DuoMAG 70BFP (70BFP1, 70BFP2), typical use for blinded studies).
干预措施: rTMS (Device)
结局指标
主要结局
Cornell Scale for Depression in Dementia (CSDD)
时间窗: from baseline to day 20
Mood assessment tool
次要结局
- Montreal Cognitive Assessment (MOCA)(from baseline to day 20)
- NPI-Q(from baseline to day 20)
- The ratio of patients who completed the study and drop-outs due to non-compliance(During all the study period)
- Possible changes of structural MRI before as compared to after the treatment(from baseline to day 20)
研究者
Prof Armin von Gunten
Professor, MD
Centre Hospitalier Universitaire Vaudois