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| ID | Type | Description | Link |
|---|---|---|---|
| CX00164501A2 | Other Grant/Funding Number | CSR&D |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NFB Intervention and Delayed Intervention | Experimental | 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 |
|
| Control Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurofeedback (NFB) | Procedure | Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. Twenty, one-hour, NFB training sessions will be provided by a trained NFB specialist over an 8-10-week period with up to 5-sessions but usually 3 sessions a week. The specific NFB special use system that will be used is the Cygnet NFB System from Bee Medic Corporation. The latest technological advances in this system has enabled training frequencies in the infra-low frequency range as well as in all other relevant frequency ranges which is a breakthrough capacity not available on any other NFB system. This will enable the individualized training to the person's brain training preference. |
| Measure | Description | Time Frame |
|---|---|---|
| Headache Impact Test (HIT-6) | 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. | 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 |
| NEUROQOLTBI Headache Pain Short Form | 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. | 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 |
| Insomnia Severity Index (ISI) | 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. | 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 |
| NEUROQOLTBI Sleep Disturbance Short Form | 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. | 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 |
| QIKtest Continuous Performance Test - Accuracy Index | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression, Anxiety and Stress Scale 21 (DASS21) | DASS21 is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Can be used as a single assessment of psychological distress (21 items, 10 min). Score varies from 0 - 63. Higher score suggests worse outcome. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judy M Carlson, EdD | VA Pacific Islands Health Care System, Honolulu, HI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Pacific Islands Health Care System, Honolulu, HI | Honolulu | Hawaii | 96819-1522 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25389484 | Background | Moshkani Farahani D, Tavallaie SA, Ahmadi K, Fathi Ashtiani A. Comparison of neurofeedback and transcutaneous electrical nerve stimulation efficacy on treatment of primary headaches: a randomized controlled clinical trial. Iran Red Crescent Med J. 2014 Aug;16(8):e17799. doi: 10.5812/ircmj.17799. Epub 2014 Aug 5. | |
| 20104400 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | NFB 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 Neurofeedback (NFB): Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. The Cygnet NFB System will be used, which enables training frequencies in the infra-low frequency range. This will enable the individualized training to the person's brain training preference. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NFB 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 Neurofeedback (NFB): Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. The Cygnet NFB System will be used, which enables training frequencies in the infra-low frequency range. This will enable the individualized training to the person's brain training preference. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Headache Impact Test (HIT-6) | 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. | Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NFB 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 Neurofeedback (NFB): Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. The Cygnet NFB System, which enables training frequencies in the infra-low frequency range will be used. This will enable the individualized training to the person's brain training preference. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient Hospitalization | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychological | Psychiatric disorders | Non-systematic Assessment | description of new or exacerbating psychological symptoms |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Judy Carlson | VA Pacific Islands Healthcare System | 808-433-6677 | judy.carlson@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 3, 2025 | Aug 8, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 13, 2023 | Jul 16, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D038223 | Post-Concussion Syndrome |
| D020773 | Headache Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D058765 | Neurofeedback |
| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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The proposed study is a randomized controlled clinical trial using Neurofeedback (NFB) as the study intervention. The control group members will continue with their usual care and will receive a 15-minute phone call from an Investigator on a weekly basis to briefly discuss one of eight possible health topics (sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies) that the treatment group would receive as a normal part of their NFB session. At the end of the Control group activities, the participant will enter the delayed intervention group. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group by a trained NFB specialist over an 8-10-week period (up to 5-sessions but usually 3 sessions a week).
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|
|
| 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 |
| Quality of Life After Brain Injury (QOLIBRI) | 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. | 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 |
| NEUROQOLTBI Satisfaction With Social Roles and Activities Short Form | 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. | 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 |
| NEUROQOLTBI Ability to Participate in Social Roles and Activities Short Form | 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. | 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 |
| NEUROQOLTBI Positive Affect and Well-being-short Form | 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. | 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) | PHQ-9 is a nine-item depression self-report module from the full Patient Health Questionnaire. Scores range from 0-27. (9 items, 2-5 min) Score varies from 0-27. Higher score suggests worse outcome. | 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) | The PCL-5 is a 20-item questionnaire, corresponding to the DSM-5 symptom criteria for PTSD. The wording of PCL-5 items reflects both changes to existing symptoms and the addition of new symptoms in DSM-5. (20 items, 5-10 min) Score varies from 0-80. Higher score suggests worse outcome. | 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) | Self-report instrument of symptoms in 7 categories including sleep, attention and learning, sensory, behavioral, emotional, physical, and pain (less than 10 min). Score varies from 0-464. Higher score suggests worse outcome. | 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 |
| Sayer NA, Rettmann NA, Carlson KF, Bernardy N, Sigford BJ, Hamblen JL, Friedman MJ. Veterans with history of mild traumatic brain injury and posttraumatic stress disorder: challenges from provider perspective. J Rehabil Res Dev. 2009;46(6):703-16. doi: 10.1682/jrrd.2009.01.0008. |
| 22121940 | Background | Morissette SB, Woodward M, Kimbrel NA, Meyer EC, Kruse MI, Dolan S, Gulliver SB. Deployment-related TBI, persistent postconcussive symptoms, PTSD, and depression in OEF/OIF veterans. Rehabil Psychol. 2011 Nov;56(4):340-50. doi: 10.1037/a0025462. |
| 23205671 | Background | Lange RT, Brickell TA, Ivins B, Vanderploeg RD, French LM. Variable, not always persistent, postconcussion symptoms after mild TBI in U.S. military service members: a five-year cross-sectional outcome study. J Neurotrauma. 2013 Jun 1;30(11):958-69. doi: 10.1089/neu.2012.2743. Epub 2013 Jun 5. |
| 23755991 | Background | Shandera-Ochsner AL, Berry DT, Harp JP, Edmundson M, Graue LO, Roach A, High WM Jr. Neuropsychological effects of self-reported deployment-related mild TBI and current PTSD in OIF/OEF veterans. Clin Neuropsychol. 2013;27(6):881-907. doi: 10.1080/13854046.2013.802017. Epub 2013 Jun 11. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Headache Impact Tool (HIT-6) | 6-item measure, score range 36-78. Higher score suggests greater impact | Mean | Standard Deviation | score on a scale |
|
| NEUROQOLTBI Headache Tool | 10-item form, scores range from: 10-50; Lower score suggests less headache pain | Mean | Standard Deviation | score on a scale |
|
| Insomnia Severity Index (ISI) | 7-item form, score range: 0-28. Higher scores suggest greater severity | Mean | Standard Deviation | score on a scale |
|
| NEUROQOLTBI Sleep Disturbance | 8-item form, score range: 8-40. Higher score suggest greater impact | Mean | Standard Deviation | score on a scale |
|
| QIK test accuracy index | Mean | Standard Deviation | score on a scale |
|
| Quality of Life after Brain Injury (QOLIBRI) | 37-item form, score range: 0-100. Higher score suggests higher quality of life | Mean | Standard Deviation | score on a scale |
|
| NEUROQOLTBI Satisfaction with roles and activities | 8-item form, score range: 8-40. Higher score suggests more satisfaction. | Mean | Standard Deviation | score on a scale |
|
| NEUROQOLTBI Ability to participate in social roles and activities | 8-item form, score range 8-40. Higher score suggest better participation ability | Mean | Standard Deviation | score on a scale |
|
| General Symptom Scale (GSI) | 116-item form, score range 0-464. Higher score suggests more severity or increased frequency | Mean | Standard Deviation | score on a scale |
|
| Depression, Anxiety and Stress Scale (DASS21) | 21 item form, score range: 0-63. Higher score suggests more distress. | Mean | Standard Deviation | score on a scale |
|
| Post-Traumatic Stress Disorder Checklist (PCL-5) | 20-item form, score range 0-80. Higher score suggests greater stress | Mean | Standard Deviation | score on a scale |
|
| Patient Health Questionnaire-Depression (PHQ9) | 9-item form, score range: 0-27. Higher score suggests greater impact | Mean | Standard Deviation | score on a scale |
|
| NEUROQOLTBI Positive affect and wellbeing | 9-item form, score range: 9-45. Higher score suggests better health | Mean | Standard Deviation | score on a scale |
|
| OG001 | 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. |
|
|
|
| Primary | NEUROQOLTBI Headache Pain Short Form | 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. | Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
|
| Primary | Insomnia Severity Index (ISI) | 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. | Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
|
| Primary | NEUROQOLTBI Sleep Disturbance Short Form | 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. | Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
|
| Primary | QIKtest Continuous Performance Test - Accuracy Index | 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. | Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
|
| Primary | Quality of Life After Brain Injury (QOLIBRI) | 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. | Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
|
| Primary | NEUROQOLTBI Satisfaction With Social Roles and Activities Short Form | 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. | Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
|
| Primary | NEUROQOLTBI Ability to Participate in Social Roles and Activities Short Form | 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. | Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
|
| Primary | NEUROQOLTBI Positive Affect and Well-being-short Form | 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. | Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
|
| Secondary | Depression, Anxiety and Stress Scale 21 (DASS21) | DASS21 is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Can be used as a single assessment of psychological distress (21 items, 10 min). Score varies from 0 - 63. Higher score suggests worse outcome. | Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
|
| Secondary | Patient Health Questionnaire-9 (PHQ-9) | PHQ-9 is a nine-item depression self-report module from the full Patient Health Questionnaire. Scores range from 0-27. (9 items, 2-5 min) Score varies from 0-27. Higher score suggests worse outcome. | Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
|
| Secondary | Posttraumatic Stress Disorder Checklist (PCL-5) | The PCL-5 is a 20-item questionnaire, corresponding to the DSM-5 symptom criteria for PTSD. The wording of PCL-5 items reflects both changes to existing symptoms and the addition of new symptoms in DSM-5. (20 items, 5-10 min) Score varies from 0-80. Higher score suggests worse outcome. | Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
|
| Secondary | General Symptom Inventory (GSI) | Self-report instrument of symptoms in 7 categories including sleep, attention and learning, sensory, behavioral, emotional, physical, and pain (less than 10 min). Score varies from 0-464. Higher score suggests worse outcome. | Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
|
| 0 |
| 43 |
| 1 |
| 43 |
| 3 |
| 43 |
| EG001 | 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. Upon completion control group activities, participants had the option to receive the neurofeedback intervention. They then followed the NFB intervention protocol. | 0 | 44 | 1 | 44 | 12 | 44 |
|
| Medical | Infections and infestations | Non-systematic Assessment | any report of infection regardless of location |
|
| Medical | Surgical and medical procedures | Non-systematic Assessment | any outpatient surgical or medical procedure |
|
| Medical | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | includes COVID-19 diagnoses |
|
| Medical | Nervous system disorders | Non-systematic Assessment |
|
| Medical | Cardiac disorders | Non-systematic Assessment |
|
| Medical | General disorders | Non-systematic Assessment | includes AEs that cross multiple systems |
|
| Medical | Vascular disorders | Non-systematic Assessment |
|
| Medical | Eye disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001521 |
| Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |
| 2-month follow-up |
|
| 2-month follow-up |
|
| 2-month follow-up |
|
| 2-month follow-up |
|
| 2-month follow-up |
|
| 2-month follow-up |
|
| 2-month follow-up |
|
| 2-month follow-up |
|
| 2-month follow-up |
|
| 2-month follow-up |
|
| 2-follow follow-up |
|
| 2-month follow-up |
|