Patient-Centered NeuroRehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- TES side effect questionnaire
研究概览
简要总结
As individuals grow older, a number of factors can reduce our cognitive (or thinking) abilities such as "normal" aging, neurodegenerative diseases, and cardiovascular disease. This study will evaluate whether cognitive rehabilitation and transcranial electrical stimulation (TES) can improve cognitive abilities. Cognitive rehabilitation refers to methods that are used to improve tasks people have trouble doing in everyday life. Transcranial electrical stimulation uses small amounts of electricity to try to alter brain functioning. These approaches may help improve cognitive abilities like attention, learning, memory, finding words, and problem solving as well as everyday functioning. The goal of this study is to identify how to best use these methods, either alone or in combination.
详细描述
The primary objective of this study is to evaluate the feasibility of a neurorehabilitation treatment tailored to individual patient needs, with the ultimate goal of maximizing cognitive and real-world functioning for older adults with cognitive aging, mild cognitive impairment (MCI), neurodegenerative, or other neurological diseases/conditions.
Transcranial electrical stimulation (TES) is a non-invasive, neurorehabilitation procedure in which a weak electric current is passed between electrodes that are placed on the scalp with the intention of modulating excitability of the underlying brain regions. Because the field of TES is relatively young, rapidly evolving, and primarily focused on cognitive neuroscience with "healthy" individuals, there is a clear need for well-conceptualized and conducted clinical research. The current protocol is intentionally broad with respect to both methodology and patient characteristics in order to tailor potential TES interventions to individual patients or small samples. The current protocol utilizes various forms of TES including transcranial direct current stimulation (tDCS), alternating current stimulation (tACS), and random noise stimulation (tRNS) and sham stimulation in older adults. As this is a cross-over design, some participants may receive active (or "real") TES and/or sham TES conditions.This includes head to head comparisons of the different forms of TES. Additionally, TES could be performed in conjunction with cognitively-based intervention since this may enhance the neuroplastic response of the targeted brain region(s) while at the same time shaping/optimizing the pathways that are engaged by cognitively-based interventions. This broad approach is important since etiological differences in cognitive impairment may necessitate distinct interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Given the nature of this study, the participant, care provider, investigator, and/or outcome assessors may or may not be blinded to the treatment condition.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who have reported cognitive dysfunction and cognitively intact participants.
- •Participants will be age 50 or older
排除标准
- •A history of epilepsy
- •Sensory or motor impairments that limit the ability to take part in the study
- •Current alcohol or drug abuse/dependence
- •Those who are currently pregnant or may become pregnant during the duration of the study (if there is a question of pregnancy, pregnancy tests will be available for participants at no charge)
- •Those who are being evaluated for TES methodology will also be excluded for 1) metallic or electronic implant 2) skull plates or other cranial implants that affect TES
研究组 & 干预措施
Active TES
Participants will receive "real" tES (tDCS, tACS, tRNS) in which they receive up to 4 milliamps (mA) of stimulation per electrode for up to 40 minutes for up to 260 sessions. As this may be a cross-over design, some participants may receive active and sham conditions.
干预措施: Active tRNS (Device)
Sham TES
Participants undergoing this condition will have the exact same procedures as the active group, with the exception that they will receive only sham stimulation for up to 260 sessions.
干预措施: Sham tDCS (Device)
Active TES
Participants will receive "real" tES (tDCS, tACS, tRNS) in which they receive up to 4 milliamps (mA) of stimulation per electrode for up to 40 minutes for up to 260 sessions. As this may be a cross-over design, some participants may receive active and sham conditions.
干预措施: Active tDCS (Device)
Active TES
Participants will receive "real" tES (tDCS, tACS, tRNS) in which they receive up to 4 milliamps (mA) of stimulation per electrode for up to 40 minutes for up to 260 sessions. As this may be a cross-over design, some participants may receive active and sham conditions.
干预措施: Active tACS (Device)
Sham TES
Participants undergoing this condition will have the exact same procedures as the active group, with the exception that they will receive only sham stimulation for up to 260 sessions.
干预措施: Sham tACS (Device)
Sham TES
Participants undergoing this condition will have the exact same procedures as the active group, with the exception that they will receive only sham stimulation for up to 260 sessions.
干预措施: Sham tRNS (Device)
Cognitively based intervention
Participants may receive a cognitively based intervention that targets the particular cognitive and/or functional abilities of interest. This includes methods of cognitive training, cognitive remediation, and cognitive rehabilitation.
干预措施: Cognitively based intervention (Behavioral)
Active TES + Cognitively based intervention
This condition combines active TES and cognitively based interventions for some or all of the study sessions
干预措施: Active tDCS (Device)
Active TES + Cognitively based intervention
This condition combines active TES and cognitively based interventions for some or all of the study sessions
干预措施: Cognitively based intervention (Behavioral)
Active TES + Cognitively based intervention
This condition combines active TES and cognitively based interventions for some or all of the study sessions
干预措施: Active tACS (Device)
Active TES + Cognitively based intervention
This condition combines active TES and cognitively based interventions for some or all of the study sessions
干预措施: Active tRNS (Device)
Sham TES + Cognitively based intervention
This condition combines sham TES and cognitively based interventions for some or all of the study sessions
干预措施: Sham tDCS (Device)
Sham TES + Cognitively based intervention
This condition combines sham TES and cognitively based interventions for some or all of the study sessions
干预措施: Cognitively based intervention (Behavioral)
Sham TES + Cognitively based intervention
This condition combines sham TES and cognitively based interventions for some or all of the study sessions
干预措施: Sham tACS (Device)
Sham TES + Cognitively based intervention
This condition combines sham TES and cognitively based interventions for some or all of the study sessions
干预措施: Sham tRNS (Device)
Active TES, Sham TES, Cognitively based interventions
This condition combines active and sham TES with cognitively based interventions using a cross-over design
干预措施: Active tDCS (Device)
Active TES, Sham TES, Cognitively based interventions
This condition combines active and sham TES with cognitively based interventions using a cross-over design
干预措施: Sham tDCS (Device)
Active TES, Sham TES, Cognitively based interventions
This condition combines active and sham TES with cognitively based interventions using a cross-over design
干预措施: Cognitively based intervention (Behavioral)
Active TES, Sham TES, Cognitively based interventions
This condition combines active and sham TES with cognitively based interventions using a cross-over design
干预措施: Active tACS (Device)
Active TES, Sham TES, Cognitively based interventions
This condition combines active and sham TES with cognitively based interventions using a cross-over design
干预措施: Sham tACS (Device)
Active TES, Sham TES, Cognitively based interventions
This condition combines active and sham TES with cognitively based interventions using a cross-over design
干预措施: Active tRNS (Device)
Active TES, Sham TES, Cognitively based interventions
This condition combines active and sham TES with cognitively based interventions using a cross-over design
干预措施: Sham tRNS (Device)
Active and Sham TES
Participants will receive active and sham TES
干预措施: Active tDCS (Device)
Active and Sham TES
Participants will receive active and sham TES
干预措施: Sham tDCS (Device)
Active and Sham TES
Participants will receive active and sham TES
干预措施: Active tACS (Device)
Active and Sham TES
Participants will receive active and sham TES
干预措施: Sham tACS (Device)
Active and Sham TES
Participants will receive active and sham TES
干预措施: Active tRNS (Device)
Active and Sham TES
Participants will receive active and sham TES
干预措施: Sham tRNS (Device)
结局指标
主要结局
TES side effect questionnaire
时间窗: Immediately following TES (<15 minutes)
Side effect questionnaire that asks participants to rate the severity of potential TES related side effects
次要结局
未报告次要终点
研究者
Benjamin Hampstead, PhD
Investigator
University of Michigan