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临床试验/NCT03638284
NCT03638284已完成不适用

Non Invasive Brain Stimulation for Treatment of Neuropsychiatric Symptoms of Dementia: an Open Label Pilot Study Using Transcranial Direct Current Stimulation

Centre for Addiction and Mental Health2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2018年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
The rate of successful completion of the 2 week tDCS treatment course and rates of treatment associated adverse effects of tDCS in agitation due to NPSD

研究概览

简要总结

Agitation and aggression impose a tremendous burden on the individuals living with dementia, their families, caregivers, and healthcare systems. Neuropsychiatric symptoms of dementia (NPS) affect up to 80% of patients with Alzheimer's dementia. These symptoms impair patient and care giver's quality of life, increase the chances of hospitalization and also result in faster progression of the illness. The efficacy of current treatments is limited and the antipsychotic medications commonly used to treat these symptoms are associated with serious side effects. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that uses a very low intensity electric current to modulate cortical excitability and brain plasticity. tDCS can be safely administered to awake persons and is very well tolerated. In this study the investigators will use tDCS to treat agitation related to NPSD.

详细描述

Agitation and aggression impose a tremendous burden on the individuals living with dementia, their families, caregivers, and healthcare systems. Neuropsychiatric symptoms of dementia (NPS) affect up to 80% of patients with Alzheimer's dementia. These symptoms include aggression and agitation, anxiety, depression, hallucinations, and delusions. These symptoms impair patient and care giver's quality of life, increase the chances of hospitalization and also result in faster progression of the illness. The efficacy of current treatments is limited and the antipsychotic medications commonly used to treat these symptoms are associated with serious side effects including cerebrovascular events, falls and increased risk of death. Electroconvulsive Therapy may be effective as well, however it requires anaesthesia and adversely affects cognition. Non-pharmacological or behavioral interventions are universally recognized as the first line treatment for agitation and NPSD. They are most effective when individualized and delivered in a person centered approach. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that uses a very low intensity electric current to modulate cortical excitability and brain plasticity. tDCS can be safely administered to awake persons and is very well tolerated. Studies in healthy individuals and patients with Alzheimer's disease have shown that tDCS applied to frontal brain regions can enhance cognitive function. Further, tDCS applied to frontal brain regions can improve depressive symptoms. The effects of tDCS on NPSD are not known. In this study the investigators will use tDCS to treat agitation related to NPSD.The objective of this proposal is to conduct an open label pilot study of tDCS for treatment of agitation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

N/a-open label study

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A clinical diagnosis of Dementia of Alzheimer's, or Mixed type.
  • Presence of agitation and/or aggression related to NPS as defined by: Agitation in cognitive disorders; International Psychogeriatric Association Provisional Consensus Clinical and Research Definition at the time of enrolment into the study.
  • Patient or Substitute Decision Maker (SDM) able and willing to provide consent for enrolment in the study.
  • Age 60 or above

排除标准

  • Having dementia other than Alzheimer's or Vascular or Mixed type.
  • DSM-5 Axis I diagnoses other than dementia that is thought to be significantly impacting the presentation such as bipolar disorder, major depressive disorder, or schizophrenia
  • Imminent safety risk that would interfere with safe conduct of the study.
  • Any contraindication to tDCS such as metal implants in cranium.

结局指标

主要结局

The rate of successful completion of the 2 week tDCS treatment course and rates of treatment associated adverse effects of tDCS in agitation due to NPSD

时间窗: 2 weeks

This will be assessed by the successful completion of the intervention in at least 80% of participants without any treatment associated serious adverse effects

次要结局

  • Effects of a 2 week course of tDCS on agitation as assessed by Cohen Mansfield Agitation Inventory (CMAI).(2 weeks, 4 weeks)
  • Effects of a 2 week course of tDCS on agitation as assessed by Neuropsychiatric Inventory (NPI).(2 weeks, 4 weeks)
  • Effects of a 2 week course of tDCS on agitation and other neuropsychiatric symptoms related to dementia as assessed by Clinical Global Impression (CGI).(2 weeks, 4 weeks)
  • Effect of tDCS on caregiver burden in agitation due to NPSD as assessed by Zarit Burden Interview (ZBI)(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sanjeev Kumar

Medical Head of Geriatric Clinical Research, Centre for Addiction and Mental Health; Clinician Scientist and Staff Psychiatrist, Campbell Family Mental Health Research Institute; Assistant Professor of Psychiatry, University of Toronto.

Centre for Addiction and Mental Health

研究点 (2)

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