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临床试验/NCT04489082
NCT04489082Enrolling By Invitation不适用

Use of Near Infrared Laser Stimulation for Treatment of Depression, Anxiety, Neurodegenerative Conditions, and Traumatic Brain Injury/Chronic Traumatic Encephalopathy

Neurological Associates of West Los Angeles2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
400
试验地点
2
主要终点
[Concussion/Traumatic Brain Injury (TBI)] Brief Pain Inventory (BPI)

研究概览

简要总结

The study will evaluate the safety and feasibility of near infrared therapy as an intervention for patients with refractory depression, anxiety, neurodegenerative disease, and traumatic brain injury.

详细描述

The present study is being undertaken as an open-label study to evaluate the safety and feasibility of near infrared therapy as an intervention for patients with refractory depression, anxiety, cognitive impairment due to a neurodegenerative disease (e.g., Alzheimer's), and traumatic brain injury. Baseline and outcome measures in this study utilize validated tests that are appropriate for repeated measures. The present study can be easily implemented because instruments have been in routine clinical deployment providing for a high degree of availability and reliability. Quality assurance is tightly controlled. The study population is sufficiently broad and the conditions of interest are sufficiently prevalent so that recruitment of subjects is not a limiting factor.

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

入排标准

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

入选标准

  • 未提供

排除标准

  • Macular degeneration
  • Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
  • Advanced kidney, pulmonary, cardiac or liver failure
  • Advanced terminal illness
  • Any active cancer or chemotherapy
  • Bone marrow disorder
  • Myeloproliferative disorder
  • Sickle cell disease
  • Primary pulmonary hypertension
  • Immunocompromising conditions and/or immunosuppressive therapies
  • Any other neoplastic illness or illness characterized by neovascularity
  • Subjects unable to give informed consent
  • Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep
  • Recent surgery or dental work within 3 months of the scheduled procedure.
  • Pregnancy, women who may become pregnant or are breastfeeding

结局指标

主要结局

[Concussion/Traumatic Brain Injury (TBI)] Brief Pain Inventory (BPI)

时间窗: 6 weeks

Self-report measure containing a composite pain score and functional interference score. The pain subscale contains 4 questions, each with answers ranging from 0 'no pain' to 10 'pain as bad as you can imagine.' Total possible score for the pain subscale is 40 points. The functional/interference subscale contains 7 questions, with each answer ranging from 0 'does not interfere' to 10 'completely interferes.' The maximum possible score for the interference subscale is 70 points. The total overall composite BPI score is out of 100 maximum points. A clinical improvement is considered a decrease in BPI overall composite score by at least 30% from baseline.

[Depression (MDD)] Beck Depression Inventory (BDI-II)

时间窗: 6 weeks

The BDI-II is a 21-question multiple-choice self-report inventory. Each question involves four possible responses, ranging in intensity from "0" (this item does not apply) to "3" (this item applies severely). The test is scored as the sum of all of the response values; this number is used to determine the severity of depressive symptoms. A score of 0 to 3 is possible for each question with a maximum total score of 63 points. The standard cutoff scores are as follows: 0-13 total points = minimal depression; 14-19 total points = mild depression; 20-28 total points = moderate depression; and 29-63 total points = severe depression. A reduction in the total score by at least 30% is considered to be clinically significant.

[Dementia] Quick Dementia Rating Scale (QDRS)

时间窗: 6 weeks

The Quick Dementia Rating Scale (QDRS) is an interview-based tool administered by study officials to participants' caregivers used to obtain observations from a consistent source. The QDRS form consists of 10 categorical questions (5 cognitive, 5 functional), each with 5 detailed options depicting the level of impairment as either 0 (normal), 0.5 (mild/inconsistent impairment), 1 (mild/consistent impairment), 2 (moderate impairment), or 3 (severe impairment). Based on the conversion table outlined in Dr. James Galvin's research (2015), total QDRS scores were converted to Clinical Dementia Rating (CDR) scale levels ranging from 0 (normal aging), 0.5 (mild cognitive impairment), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia).

[All] Global Rating of Change (GRC)

时间窗: 6 weeks

The GRC consists of a single likert-scale ranging from "-5" (very much worse) to "0" (neutral/no change) to "5" (very much better). The GRC is obtained in an interview format to assess a patient's perceived change in status following a treatment. A score that is at least 2 or greater is considered to indicate clinically significant change.

[Anxiety] Beck Anxiety Inventory (BAI)

时间窗: 6 weeks

The BAI is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety symptoms. Each of the 21 items asks whether the patient has experienced various anxiety symptoms in the last two weeks, and if so, how severely. Each question/answer is scored on a scale value of "0" (not at all) to "3" (severely). Higher total scores indicate more severe anxiety symptoms. The maximum total score possible is 63 points. The standard cutoff scores are: 0-7 = minimal anxiety; 8-15 = mild anxiety; 16-25 = moderate anxiety; 26-63 = severe anxiety. A reduction in score by at least 30% is considered clinically meaningful.

次要结局

  • [Anxiety] Hamilton Anxiety Rating Scale (HAM-A)(4 weeks post last day of treatment)
  • [Dementia] Repeatable Battery Assessment of Neuropsychological Status (RBANS) versions A-D(4 weeks post last day of treatment)
  • [MDD] Hamilton Depression Rating Scale (HAM-D)(4 weeks post last day of treatment)
  • [Anxiety] Beck Anxiety Inventory (BAI)(4 weeks post last day of treatment)
  • [Dementia] Quick Dementia Rating Scale (QDRS)(4 weeks post last day of treatment)
  • [MDD] Beck Depression Inventory (BDI-II)(4 weeks post last day of treatment)
  • [TBI] Brief Pain Inventory (BPI)(4 weeks post last day of treatment)
  • [All] Global Rating of Change (GRC)(4 weeks post last day of treatment)
  • [MDD & TBI] Patient Depression Questionnaire (PDQ-9)(4 weeks post last day of treatment)
  • [Dementia] Montreal Cognitive Assessment (MoCA) versions 7.1-7.3(4 weeks post last day of treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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