Neurofeedback Impact on Chronic Headache, Sleep and Attention Disorders Experienced by Veterans With Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Headache Impact Test (HIT-6)
研究概览
简要总结
This study will evaluate neurofeedback (NFB) training as a low risk, non-invasive, effective treatment for Veterans diagnosed with mild traumatic brain injury (mTBI) and experiencing chronic post-concussive symptoms (PCSs). Participants will be randomized into the intervention or control group. Groups will be compared on primary measures of headache, insomnia and attention. Other outcomes of interest include post-traumatic stress symptoms, depression, quality of life and other measures of well-being.
详细描述
This study will evaluate neurofeedback (NFB) training as a low risk, non-invasive, effective treatment for Veterans diagnosed with mild traumatic brain injury (mTBI) and experiencing chronic post-concussive symptoms (PCSs). Participants will be randomized into the intervention or control group. Groups will be compared on primary measures of headache, insomnia and attention. Other outcomes of interest include post-traumatic stress symptoms, depression, quality of life and other measures of well-being.
Both the intervention and control group will participate in four assessment sessions. The assessment sessions will occur at the beginning of the study, at 4-6 weeks, at 8-10 weeks, and 2-months later. Participation in this research will last about 4 months. Those in the control group will be offered neurofeedback treatment, extending their participation time by 4 months (8 months total participation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Male and non-pregnant female OEF-OIF-OND Veterans diagnosed with mTBI ages 18 to 65
- •Complaints of chronic headaches, insomnia, and attention difficulties
- •Able to read and write English
- •Able to comprehend what they read
- •Able to follow directions
排除标准
- •Pregnant female Veteran
- •Non OEF-OIF-OND Veteran who is diagnosed with mTBI
- •Under the age of 18 or over the age of 65
- •Severe TBI
- •Impaired decision-making capacity
- •Unable to comply with study visit schedule
- •Suicide Intent as indicated by a positive response to questions 3, 4, 5, or 8 on the Columbia Suicide Severity Rating Scale (C-SSRS) secondary screen
研究组 & 干预措施
NFB Intervention and Delayed Intervention
The NFB system will read and interpret a participant's brain wave pattern which will be instantaneously fed back to the participant providing information, to which a participant can respond accordingly. The NFB specialist assumes a coaching role with people training on the NFB special use system to assist in the achievement of a focused relaxed state, which enhances the overall brain functioning. The significance and unique aspect of NFB is the direct impact on physiological dysregulation, which is the basis of this treatment approach. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group and Delayed intervention group (those participants who completed the Control Group activities) by a trained NFB specialist over an 8-10-week period. Participants in the intervention group will receive up to 5-sessions but usually 3 sessions a week
干预措施: Neurofeedback (NFB) (Procedure)
Control Group
Participants in the control group will continue with their usual treatment and will receive a 15-minute call once a week for eight weeks from an Investigator on a health topic. This will help to keep members of the control group engaged in the project and receive the same information that is offered to the intervention group members. The health topics that are generally discussed during NFB sessions include sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies.
结局指标
主要结局
Headache Impact Test (HIT-6)
时间窗: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up
The HIT-6 is a 6-question tool designed to describe and communicate the way people feel and what they cannot do because of their headache. (6 questions, 3 min) Scores vary from 36 - 78. Higher score worse outcome.
NEUROQOLTBI Headache Pain Short Form
时间窗: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up
Developed as part of NIH Toolbox NEUROQOL TBI. It is comprised of 10 questions related to the nature and response to headaches. (10 items, 5 minutes). Score range 10-50. Higher scores suggest worse outcome.
Insomnia Severity Index (ISI)
时间窗: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up
Seven question self-report instrument used to quantify perceived current insomnia. Targets past week's symptoms and daytime consequences consistent with DSM-IV criteria. (7 items, 5 min) Scores vary from 0 - 28. Higher score worse outcome.
NEUROQOLTBI Sleep Disturbance Short Form
时间窗: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up
Developed as part of NIH Toolbox NEUROQOL TBI. It is comprised of 8 questions related to the sleep experience and impact. (8 items, 5 minutes). Score range: 8-40. Higher scores suggest worse outcome.
QIKtest Continuous Performance Test - Accuracy Index
时间窗: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up
Computerized visual performance test to assess attention and impulse control, speed and consistency of response. Specifically intended for use by neurofeedback clinicians. (21 min). Higher scores indicate better performance. Score range: 165-420.
Quality of Life After Brain Injury (QOLIBRI)
时间窗: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up
A 37-item instrument consisting of 6 scales measuring cognition, self, daily life and autonomy, social relationships, emotions, and physical problems. Designed to measure quality of life specific for TBI. (37 items, 15 min). Score range: 0-100. Higher score suggests better outcome.
NEUROQOLTBI Satisfaction With Social Roles and Activities Short Form
时间窗: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up
Developed as part of NIH Toolbox NEUROQOL TBI. It is comprised of 10 questions related to level of satisfaction with life roles and activities. (10 items, 5 min). Score range: 8-40. Higher score suggests better outcome.
NEUROQOLTBI Ability to Participate in Social Roles and Activities Short Form
时间窗: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up
Developed as part of NIH Toolbox NEUROQOL TBI. It is comprised of 10 questions related to level of ability to do life roles and activities. (10 items, 5 min). Score range 8-40. Higher score suggests better outcome.
NEUROQOLTBI Positive Affect and Well-being-short Form
时间窗: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up
Developed as part of NIH Toolbox NEUROQOL TBI. It is comprised of 10 questions related to level of positive attitude and sense of well-being (9 items, 5 min). Score range: 9-45. Higher score better outcome.
次要结局
- Depression, Anxiety and Stress Scale 21 (DASS21)(Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up)
- Patient Health Questionnaire-9 (PHQ-9)(Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up)
- Posttraumatic Stress Disorder Checklist (PCL-5)(Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up)
- General Symptom Inventory (GSI)(Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up)