Transcranial Photobiomodulation to Improve Cognition in TBI, With Pre-/Post- fMRI Scans: A Pilot, Sham-Controlled Study
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- CVLT-II, Long Delay Free Recall 3
研究概览
简要总结
The purpose of this small, research study is to examine effectiveness of an at-home application of an experimental intervention, on thinking and memory in mild-moderate, closed-head, traumatic brain injury cases. The experimental intervention is light-emitting diode (LED) therapy, which is applied to the scalp and through the nose using a head frame device. Participants are expected to complete two, 5-week series of LED treatments, at home, 3 times a week. There will be a 1-month period between the two series. Each home treatment is 20 minutes. Participants will be trained to use the head frame device, in-office. The head frame device falls within the FDA category General Wellness, low-risk devices, and no medical claims are made. A two-hour paper and pencil testing (4 visits) and a one-hour MRI (3 visits) will be administered before and after each treatment series. Participants may be in the study for about 4 months. This study is supported by Vielight, Inc., Hayward, CA/ Toronto, Canada
详细描述
Objectives: This small study examines effectiveness of an at-home experimental intervention that utilizes near-infrared (NIR) wavelengths of light (810nm) applied to the scalp, using light-emitting diodes (LEDs), to improve brain function. LEDs may directly improve the cellular activity of brain tissue that has been damaged by brain trauma. The intervention involves two series of 15 treatments, which are self-administered, at-home. Neuropsychological testing and structural and functional MRI (fMRI) scans will be administered to examine behavioral and brain changes before and after a series of LED treatments. MRI scans will examine some mechanism of LED intervention including changes in blood flow, functional connectivity and neurochemicals.
Research Design: This study is a blinded, randomized, sham-controlled, partial-crossover study, with 2 groups (n=10 per group (Sham, Real); ages 18-65). Participants are randomized, by computer into groups. At-home LED intervention is self-administered 3 times per week (20 minutes), for two 5-week series, with a one-month break between series. Group 1 receives both a series of Sham and a series of Real treatments and Group 2 receives two series of Real treatments. All participants will receive at least one series of Real treatments during participation.
Methods and General Study Procedure: Twenty veterans with traumatic brain injury, 18-65 years old, who are at least 6-months post- the latest mild-moderate traumatic brain injury (TBI) will be studied. A 1-hour, In-office neuropsychological (NP) screening, after consenting, will determine study eligibility and ensure participants meet the inclusion/exclusion criteria. Participants may be in the study for about 4 months.
Device Parameters: Vielight Neuro Alpha head frame device, NIR, 810nm, pulsed at 10 Hz, 50% duty cycle, 20-minute treatment with automatic shutoff. Total Energy Dose per head set plus intranasal: 225 J/cm2+ 15 J/cm2 = 240 J/cm2 per 20 min LED treatment. Total Energy Dose delivered (3x/Week, 5 Weeks) = 3600 J/cm2. The light from these LEDs is not visible to the eye. There is no potential for eye damage because the LEDs are not laser light.
Sham and Real devices are identical in look and feel, except no photons are emitted from the Sham devices. The head frame device falls within the FDA category General Wellness, low-risk devices, and no medical claims are made. It is approved for use by the VA Boston Healthcare System Safety and Human Subjects Committees.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
After consent/screening participant is randomized by computer into Group 1 or Group 2 in blocks of 10. The participant, investigator and outcome assessor is blinded to Group.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old
- •Must have had one (or more) closed-head, traumatic brain injuries
- •Loss of consciousness 24 hours or less; or no loss of consciousness/ A period of altered mental status (post-traumatic amnesia)/mental confusion for 24 hours or less
- •Must be able to come to VA Boston Healthcare System, Jamaica Plain Campus for testing visits and Boston University Center for Biomedical Imaging, Boston University School of Medicine for MRI scans
- •Must meet the following Screening requirements:
- •Participants must score at least 2 SD below normal on at least 1 of the NP tests; or 1 SD below on at least 2 of these NP tests administer at Entry testing: Trail Making Test A & B; Controlled Oral Word Association Test (COWAT/FAS); California Verbal Learning Test II; DKEFS Color-Word Interference Test (Stroop).
排除标准
- •Diagnosis of a neurological disease such amyotrophic lateral sclerosis (ALS), Parkinson's, Alzheimer's disease
- •History of craniotomy or craniectomy
- •A current life-threatening disease such as cancer
- •Disease requiring organ transplant
- •A severe mental disorder such as schizophrenia, bipolar disorder (not associated with clinically diagnosed PTSD)
- •Current substance abuse or active treatment; within the last 6 months
- •The Test of Memory Malingering is administered at screening; Participants must not have scores that indicate evidence of malingering, a score of less than 45 on either Part 1 or 2 would show evidence of malingering, with the following exception: If a participant fails Trial 1, but does not fail Trial 2, he/she would not be excluded if he/she also show evidence of poor learning on other NP Screening tests, such as the CVLT. If he/she fails Trial 2, alone, or Trial 1 and Trial 2, then this would exclude the participant from the study.
- •Self-reported pain questionnaires (VAS Pain Rating and the Short Form McGill Pain Questionnaire) are also administered. Participants may not have a level of pain greater than 7/10 on VAS or 38/50 on the McGill pain questionnaires at the time of screening.
- •Exclusion for Magnetic Resonance Imaging Only
- •A BU MRI safety screening form will be reviewed at the time of study screening, as well as at each MRI scan appointment to ensure the participant can safely have an MRI. Participants must tell the investigator about any operations and any metal in his/her body, so it can be decided if it is safe for you to proceed with the scan.
- •Participants cannot have a MRI scan:
- •if pregnant.
- •if he/she has pacemakers, ear implants, shrapnel injuries, or other types of metal or electric device in their body
结局指标
主要结局
CVLT-II, Long Delay Free Recall 3
时间窗: Change from 1-Week to 1-Month after Series 1
California Verbal Learning Test-II Long Delay (20 mins) Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome. After a 20 minute delay (other tasks run during this delay), participant is asked to recall items from List A. Total is number of words recalled. Alternate lists are used at each testing timepoint to avoid practice effect
CVLT-II, Long Delay Free Recall 4
时间窗: Change from Pre-Treatment Baseline to 1-Week after Series 2
California Verbal Learning Test-II Long Delay (20 mins) Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome. After a 20 minute delay (other tasks run during this delay), participant is asked to recall items from List A. Total is number of words recalled. Alternate lists are used at each testing timepoint to avoid practice effect
CVLT-II, Long Delay Free Recall 1
时间窗: Change from Pre-Treatment Baseline to 1-Week after Series 1
California Verbal Learning Test-II Long Delay (20 mins) Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome. After a 20 minute delay (other tasks run during this delay), participant is asked to recall items from List A. Total is number of words recalled. Alternate lists are used at each testing timepoint to avoid practice effect
CVLT-II, Long Delay Free Recall 2
时间窗: Change from Pre-Treatment Baseline to 1-Month after Series 1
California Verbal Learning Test-II Long Delay (20 mins) Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome. After a 20 minute delay (other tasks run during this delay), participant is asked to recall items from List A. Total is number of words recalled. Alternate lists are used at each testing timepoint to avoid practice effect
次要结局
- Delis-Kaplan Executive Function Trails (Condition 2) 4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- Quality of Community Integration Questionnaire Cognitive Quality of Life Score 2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- Tinnitus Functional Index 1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- Tinnitus Functional Index 3(Change from 1-Week to 1-Month after Series)
- Tinnitus Functional Index 4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- Delis-Kaplan Executive Function Trails (Condition 4) 1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- Benton Visual Memory Test; Trial 1 Immediate Recall 2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- Benton Visual Memory Test; Trial 1 Immediate Recall 3(Change from 1-Week to 1-Month after Series 1)
- Benton Visual Memory Test; Delayed Recall 1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- Benton Visual Memory Test; Delayed Recall 4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- Delis-Kaplan Executive Function Trails (Condition 4) 3(Change from 1-Week to 1-Month after Series 1)
- Benton Visual Memory Test; Total Trials 2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- Beck Depression Inventory (BDI) 1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- Beck Depression Inventory (BDI) 3(Change from 1-Week to 1-Month after Series 1)
- Quality of Community Integration Questionnaire Cognitive Quality of Life Score 4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- Benton Visual Memory Test; Trial 1 Immediate Recall 4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- Benton Visual Memory Test; Total Trials 1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- Benton Visual Memory Test; Total Trials 3(Change from 1-Week to 1-Month after Series 1)
- Benton Visual Memory Test; Delayed Recall 2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- Beck Depression Inventory (BDI) 2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- Dysexecutive Functional Index (DEX) 2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- Tinnitus Functional Index 2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- CVLT-II, Short Delay Cued Recall 1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- CVLT-II, Long Delay Cued Recall 4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- Color-Word Interference (Stroop) Test, Trial 3 _3(Change from 1-Week to 1-Month after Series 1)
- Color-Word Interference (Stroop) Test, Trial 4 _3(Change from 1-Week to 1-Month after Series 1)
- Color-Word Interference (Stroop) Test, Trial 4 _4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- CVLT-II, Short Delay Free Recall 2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- CVLT-II, Short Delay Cued Recall 2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- CVLT-II, Short Delay Cued Recall 3(Change from 1-Week to 1-Month after Series 1)
- CVLT-II, Long Delay Cued Recall 2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- CVLT-II, Long Delay Cued Recall 3(Change from 1-Week to 1-Month after Series 1)
- Color-Word Interference (Stroop) Test, Trial 3 _1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- Benton Visual Memory Test; Delayed Recall 3(Change from 1-Week to 1-Month after Series 1)
- Beck Depression Inventory (BDI) 4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- Post Traumatic Stress Disorder (PCL) 1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- CVLT-II, Short Delay Free Recall 1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- CVLT-II, Short Delay Free Recall 3(Change from 1-Week to 1-Month after Series 1)
- CVLT-II, Short Delay Free Recall 4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- Post Traumatic Stress Disorder (PCL) 2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- Short Form, McGill Pain Questionnaire 3(Change from 1-Week to 1-Month after Series 1)
- Short Form, McGill Pain Questionnaire 4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- Quality of Community Integration Questionnaire Total CIQ Score 4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- Quality of Community Integration Questionnaire Cognitive Satisfaction Score 1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- Quality of Community Integration Questionnaire Cognitive Satisfaction Score 3(Change from 1-Week to 1-Month after Series)
- Quality of Community Integration Questionnaire Cognitive Quality of Life Score 3(Change from 1-Week to 1-Month after Series)
- Dysexecutive Functional Index (DEX) 1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- Dysexecutive Functional Index (DEX) 3(Change from 1-Week to 1-Month after Series)
- Dysexecutive Functional Index (DEX) 4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- Post Traumatic Stress Disorder (PCL) 3(Change from 1-Week to 1-Month after Series 1)
- Post Traumatic Stress Disorder (PCL) 4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- Short Form, McGill Pain Questionnaire 1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- Pittsburgh Sleep Quality Index (PSQI) 1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- Quality of Community Integration Questionnaire (QCIQ) Score 1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- Visual Analog Pain Rating Scale (VAS) 1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- Visual Analog Pain Rating Scale (VAS) 3(Change from 1-Week to 1-Month after Series 1)
- CVLT-II, Short Delay Cued Recall 4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- CVLT-II, Long Delay Cued Recall 1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- Visual Analog Pain Rating Scale (VAS) 2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- Visual Analog Pain Rating Scale (VAS) 4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- Short Form, McGill Pain Questionnaire 2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- Quality of Community Integration Questionnaire (QCIQ) Score 2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- Quality of Community Integration Questionnaire (QCIQ) Score 3(Change from 1-Week to 1-Month after Series)
- Pittsburgh Sleep Quality Index (PSQI) 4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- Quality of Community Integration Questionnaire Total CIQ Score 2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- Quality of Community Integration Questionnaire (QCIQ) Score 4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- Quality of Community Integration Questionnaire Cognitive Satisfaction Score 2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- Quality of Community Integration Questionnaire Cognitive Satisfaction Score 4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- Quality of Community Integration Questionnaire Cognitive Quality of Life Score 1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- CVLT-II, Total Trials 1-5 _1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- CVLT-II, Total Trials 1-5 _2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- CVLT-II, Total Trials 1-5 _3(Change from 1-Week to 1-Month after Series 1)
- CVLT-II, Total Trials 1-5 _4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- Color-Word Interference (Stroop) Test, Trial 3 _2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- Color-Word Interference (Stroop) Test, Trial 3 _4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- Delis-Kaplan Executive Function Trails (Condition 4) 2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- Delis-Kaplan Executive Function Trails (Condition 4) 4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- Benton Visual Memory Test; Trial 1 Immediate Recall 1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- Benton Visual Memory Test; Total Trials 4(Change from Pre-Treatment Baseline to 1-Week after Series 2)
- Color-Word Interference (Stroop) Test, Trial 4 _1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- Delis-Kaplan Executive Function Trails (Condition 2) 1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- Delis-Kaplan Executive Function Trails (Condition 2) 2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- Color-Word Interference (Stroop) Test, Trial 4 _2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- Pittsburgh Sleep Quality Index (PSQI) 2(Change from Pre-Treatment Baseline to 1-Month after Series 1)
- Pittsburgh Sleep Quality Index (PSQI) 3(Change from 1-Week to 1-Month after Series)
- Quality of Community Integration Questionnaire Total CIQ Score 1(Change from Pre-Treatment Baseline to 1-Week after Series 1)
- Quality of Community Integration Questionnaire Total CIQ Score 3(Change from 1-Week to 1-Month after Series)
- Delis-Kaplan Executive Function Trails (Condition 2) 3(Change from 1-Week to 1-Month after Series 1)