Use of Transcranial Photobiomodulation to Improve Cognition and Self-Reported Outcomes in Survivors of Childhood Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Number of participants who completed a two-month trial of paired photobiomodulation (PBM) therapy and cognitive training
研究概览
简要总结
Survivors of childhood cancer are at greater risk for long-term cognitive impairments that include attention, executive function, intelligence, memory, and processing speed. The participants are a survivor of acute lymphoblastic leukemia (ALL) or Hodgkin's lymphoma (HL). Because of your treatment the participant may have developed trouble with thinking and learning.
Primary Objective
To evaluate the feasibility of using home-based tPBM paired with remote cognitive training to improve cognitive performance in survivors of ALL and HL.
Secondary Objectives
To estimate the potential efficacy of alpha and gamma frequency tPBM on cognitive performance in survivors of ALL and HL.
Exploratory Objectives
To estimate the effects of home-based tPBM paired with remote cognitive training on patient reported symptoms of executive dysfunction, sleep, depression, anxiety, fatigue, and pain in survivors of ALL and HL.
详细描述
Survivors with ALL and HL with identified executive function impairment will be randomized to receive stimulation with alpha tPBM + cognitive training, gamma tPBM + cognitive training or sham tPBM + cognitive training three days per week for a 2-month intervention period The tPBM will be applied to nodes in the default mode network.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The proposed study is a double-blind, randomized placebo-controlled pilot study of remotely delivered tPBM paired with cognitive training.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed treatment for acute lymphoblastic leukemia (ALL) or Hodgkin's Lymphoma (HL) at SJCRH.
- •Enrolled in SJLIFE, and less than 21 years of age at diagnosis.
- •18 years of age or older at time of enrollment.
- •2 years or greater post-treatment completion of cancer directed therapy and not currently receiving any cancer directed therapy.
- •English language proficiency.
- •Access to WiFi.
- •Executive dysfunction defined as having an age-adjusted standard score less than 16th percentile on objectively assessed cognitive test or patient-reported executive dysfunction defined as having a standard score greater than 84th percentile within 3 years of time of enrollment.
排除标准
- •Estimated intelligence score less than
- •Currently taking medication intended to treat neurocognitive impairment (i.e., stimulants).
- •Major psychiatric condition.
- •Alcohol abuse in the past year (AUDIT) [greater than or equal to 13 for women and greater than or equal to 15 for men]. The Alcohol Use Disorders Identification Test (AUDIT) will be used to screen for individuals who have active alcohol-use disorders.
- •Drug abuse in the past year (DAST-10) [ greater than or equal to 3 for women or men] The Drug Abuse Screen Test (DAST-10) will be used to screen for individuals with active drug abuse.
- •History of neurologic condition or genetic disorder associated with neurocognitive impairment unrelated to cancer diagnosis or treatment.
- •Enrolled on another independent cognitive intervention protocol within the last year.
- •Female participants who are pregnant or lactating (determined by participant self-report due to the remote nature of this study)
- •Tattoo or artificial marking in the area where the device will be positioned.
研究组 & 干预措施
alpha tPBM + cognitive training
three days per week for a 2-month intervention period (5 ALL and 5 HL)
干预措施: Transcranial photobiomodulation (tPBM) - Mobile System (Device)
gamma tPBM + cognitive training
three days per week for a 2-month intervention period (5 ALL and 5 HL)
干预措施: Transcranial photobiomodulation (tPBM) - Mobile System (Device)
sham tPBM + cognitive training
Sham stimulations will act as the control for this study three days per week for a 2-month intervention period (5 ALL and 5 HL)
干预措施: Transcranial photobiomodulation (tPBM) - Mobile System (Device)
结局指标
主要结局
Number of participants who completed a two-month trial of paired photobiomodulation (PBM) therapy and cognitive training
时间窗: 4 months after participant enrollment
The trial will be considered feasible if at least 15 of 30 survivors are able to complete 18 of 24 sessions (PBM along with cognitive training).
次要结局
- CNS Vital Signs implemented Shifting Attention Test.(2 month and 4 months after enrollment)
- CNS Vital Signs implementation of the Continuous Performance Test (CPT).(2 month and 4 months after enrollment)
- CNS Vital Signs adaptions of the Rey auditory verbal learning test (RVLT).(2 month and 4 months after enrollment)
- CNS Vital Signs adaptions of the Rey visual design learning (RVDL) test.(2 month and 4 months after enrollment)
- CNS Vital Signs implemented Stroop color and word test.(2 month and 4 months after enrollment)