Assessment of Effectiveness and Safety of Transcranial Magnetic Stimulation (rTMS) Combined With Transcranial Direct Current Stimulation (tDCS) in Dementia Treatment in Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Zarit Burden Interview
研究概览
简要总结
Alzheimer's disease is the most common disease responsible for dementia, accounting for 40-70% of all dementia cases. Alzheimer's disease is characterized by a gradual and slow decline in memory and other cognitive functions and activities.
The medications currently used in Alzheimer's disease were introduced in the 1990s and exhibit insufficient effectiveness. Despite their use, the disease rapidly progresses, leading to complete loss of independence and death. There are conducted numerous studies on new molecules, however none of them has been successfully accomplished so far. Transcranial magnetic stimulation (TMS) is one of the youngest electrophysiological methods, enabling non-invasive and painless stimulation of the central and peripheral nervous system. Another non-invasible neurophysiological method that is utilized in treating patients with neurological dysfunctions and mental disorders is Transcranial direct current stimulation (tDCS). Clinical trials conducted with isolated usage of rTMS and tDCS showed a positive effect of these methods on the enhancement of cognitive functions in patients with Alzheimer's disease.
The aim of the project is to evaluate the effectiveness and safety of the combination of Repetitive Transcranial Magnetic Resonance (rTMS) with Transcranial direct current stimulation in the treatment of Alzheimer's dementia. The primary goal of the project is to assess whether the use of combined tDCS and rTMS therapies in patients diagnosed with mild to moderate Alzheimer's disease improves patients' cognitive functions, including memory, attention, thinking, executive and language functions. The research hypothesis assumes that the combination of rTMS and tDCS therapy is an effective method of Alzheimer's disease therapy that can improve cognitive functions and functioning of patients, both in the short and long term.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild to moderate dementia in Alzheimer's disease, diagnosed using DSM-5 criteria.
- •MMSE score from 12 to 26 points
- •ADAS-Cog over 17 points
- •Voluntary consent to participate in the study
- •there is a related person or legal guardian who consented to assist the patient in the course of the study
- •Minimum 8 years of education.
- •It is allowed to use cholinesterase inhibitors and / or memantine for at least 3 months prior to study entry and at a stable dose for at least 60 days prior to study entry.
排除标准
- •Severe agitation
- •Intellectual Disability
- •Informed consent is not possible
- •Unstable somatic condition
- •Use of benzodiazepines or barbiturates 2 weeks prior to screening
- •Participation in a clinical trial with coinciding factors within 6 months prior to the start of the trial
- •Contraindications to rTMS treatment according to the rTMS questionnaire attached to the protocol
- •Contraindications to tDCS treatment according to the tDCS questionnaire attached to the protocol
- •Patients with depression, bipolar, or psychotic disorders, or any other neurological or psychiatric condition (current or past) that the Investigator considers to be interfering with the study
- •Alcoholism or drug addiction as defined by DSM-5 in the last 5 years (addicted for more than a year and or in remission for less than 3 years)
- •Patients with any medical condition that the Investigator considers to be an exclusion criterion from the study
研究组 & 干预措施
rTMS stimulation
20 sessions of stimulation with increasing intensity, reaching maximum in the 4th session.
干预措施: Magnetic Stimulator DuoMag (Device)
tDCS stimulation
The stimulation time will be 20 minutes, the current intensity will be 2mA.
干预措施: neuroConn DC-STIMULATOR (Device)
Sham rTMS stimulation
20 sessions of stimulation, but without current.
干预措施: Magnetic Stimulator DuoMag (Device)
Sham tDCS stimulation
The stimulation time will be 20 minutes, but without current.
干预措施: neuroConn DC-STIMULATOR (Device)
结局指标
主要结局
Zarit Burden Interview
时间窗: up to 12 weeks
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
MMSE Scale
时间窗: up to 12 weeks
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
ADAS-Cog Scale
时间窗: up to 12 weeks
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
NPI Scale
时间窗: up to 12 weeks
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
ADCS
时间窗: up to 12 weeks
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
GDS
时间窗: up to 12 weeks
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
次要结局
未报告次要终点
研究者
Jakub Kazmierski
PhD
Medical University of Lodz