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The purpose of this study is to explore the functional and physiological effects associated with the use of High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), as supplemental care, for symptoms of neurological, cardiovascular, and neuropsychological disorders. This is a non-randomized, open label, and unblinded before-and-after trial, evaluating the effect of HIRREM on an objective, physiological common denominator (heart rate variability, HRV), across a variety of relevant conditions, as well as changes in clinical symptoms inventories, to generate hypotheses and pilot data for investigation in future proposals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active HIRREM | Experimental | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIRREM | Device | HIRREM is a noninvasive, closed-loop, allostatic, acoustic stimulation neuro-technology to facilitate recipient-unique relaxation, auto-calibration, and self-optimization of cortical neural oscillations by reflecting auditory tones in near real time. After an initial HIRREM assessment, evaluating patterns of brain electrical rhythms, subjects get a series of 90-120 minute HIRREM sessions, including 5 to 9 individualized protocols. A protocol is a combination of sensor montage and specific software design, during which dominant brain frequencies, recorded at high spectral resolutions, are translated to audible tones, and reflected back via earphones with as little as 8 milliseconds delay. Protocols are received sitting or reclining in a chair, some with eyes open, others eyes closed. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Variability Standard Deviation of NN Intervals (SDNN) | Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval | Baseline/Enrollment visit |
| Heart Rate Variability (SDNN) | Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval | Up to 2 weeks after the intervention is completed |
| Baroreflex Sensitivity High Frequency (HF) Alpha | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | Baseline/Enrollment visit |
| Baroreflex Sensitivity High Frequency (HF) Alpha | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | Up to two weeks after the intervention is completed |
| Baroreflex Sensitivity Sequence Up | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | Baseline/Enrollment visit |
| Baroreflex Sensitivity Sequence Up | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | Up to two weeks after the intervention is completed |
| Measure | Description | Time Frame |
|---|---|---|
| Center for Epidemiologic Studies Depression Scale (CES-D) | The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology. | enrollment visit/baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Variability Standard Deviation of NN Intervals (SDNN) | Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval | 4-8 weeks after completion of the intervention |
| Baroreflex Sensitivity High Frequency (HF) Alpha |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles H Tegeler, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23532171 | Background | Gerdes L, Gerdes P, Lee SW, H Tegeler C. HIRREM: a noninvasive, allostatic methodology for relaxation and auto-calibration of neural oscillations. Brain Behav. 2013 Mar;3(2):193-205. doi: 10.1002/brb3.116. Epub 2013 Jan 14. | |
| 23170244 | Background | Tegeler CH, Kumar SR, Conklin D, Lee SW, Gerdes L, Turner DP, Tegeler CL, C Fidali B, Houle TT. Open label, randomized, crossover pilot trial of high-resolution, relational, resonance-based, electroencephalic mirroring to relieve insomnia. Brain Behav. 2012 Nov;2(6):814-24. doi: 10.1002/brb3.101. Epub 2012 Oct 28. |
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Data will be shared in publications and presentations. No plan to formally make individual participant data available for this exploratory study
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| ID | Title | Description |
|---|---|---|
| FG000 | Active HIRREM | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active HIRREM | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Heart Rate Variability Standard Deviation of NN Intervals (SDNN) | Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval | BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats. | Posted | Mean | Standard Deviation | milliseconds | Baseline/Enrollment visit |
|
|
Informed consent until 4-8 weeks after completion of the intervention
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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 | Active HIRREM | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles H. Tegeler | Wake Forest School of Medicine | +1 (336) 716-7651 | ctegeler@wakehealth.edu |
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| 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 20, 2017 | Dec 6, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001008 | Anxiety Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D019584 | Hot Flashes |
| D006261 | Headache |
| D000070642 | Brain Injuries, Traumatic |
| D038223 | Post-Concussion Syndrome |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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|
| Baroreflex Sensitivity Sequence Down | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | Baseline/Enrollment visit |
| Baroreflex Sensitivity Sequence Down | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | Up to two weeks after the intervention is completed |
| Baroreflex Sensitivity Sequence All | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | Baseline/Enrollment visit |
| Baroreflex Sensitivity Sequence All | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | Up to 2 weeks after the intervention is completed |
| Center for Epidemiologic Studies Depression Scale (CES-D) | The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology. | 1-2 weeks after intervention is completed |
| Center for Epidemiologic Studies Depression Scale (CES-D) | The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology. | 4-8 weeks after completion of the intervention |
| Euro Quality of Life--Five Dimension (EQ-5D) | The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome. | enrollment visit/baseline |
| Euro Quality of Life--Five Dimension (EQ-5D) | The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome. | 1-2 weeks after the intervention is completed |
| Euro Quality of Life--Five Dimension (EQ-5D) | The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome. | 4-8 weeks after completion of the intervention |
| Generalized Anxiety Disorder-7 (GAD-7) | The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety. | enrollment visit/baseline |
| Generalized Anxiety Disorder-7 (GAD-7) | The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety. | 1-2 weeks after the intervention is completed |
| Generalized Anxiety Disorder-7 (GAD-7) | The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety. | 4-8 weeks after completion of the intervention |
| Insomnia Severity Index (ISI) | The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality. | enrollment visit/baseline |
| Insomnia Severity Index (ISI) | The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality. | 1-2 weeks after the intervention is completed |
| Insomnia Severity Index (ISI) | The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality. | 4-8 weeks after completion of the intervention |
| Posttraumatic Stress Disorder Checklist (PCL-C) | The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD. | enrollment visit/baseline |
| Posttraumatic Stress Disorder Checklist (PCL) | The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD. | 1-2 weeks after the intervention is completed |
| Posttraumatic Stress Disorder Checklist (PCL) | The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD. | 4-8 weeks after completion of the intervention |
| Rivermead Post-Concussion Symptoms Questionnaire (RPQ) | The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity. | enrollment visit/baseline |
| Rivermead Post-Concussion Symptoms Questionnaire (RPQ) | The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with a higher score denoting the greatest symptom severity. | 1-2 weeks after the intervention is completed |
| Rivermead Post-Concussion Symptoms Questionnaire (RPQ) | The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity. | 4-8 weeks after completion of the intervention |
| Drop Stick Reaction Testing | Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100. | enrollment visit/baseline |
| Drop Stick Reaction Testing | Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100. | 1-2 weeks after the intervention is completed |
| Drop Stick Reaction Testing | Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100. | 4-8 weeks after completion of the intervention |
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. |
| 4-8 weeks after completion of the intervention |
| Baroreflex Sensitivity Sequence Up | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | 4-8 weeks after completion of the intervention |
| Baroreflex Sensitivity Sequence Down | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | 4-8 weeks after completion of the intervention |
| Baroreflex Sensitivity Sequence All | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | 4-8 weeks after completion of the intervention |
| 24599239 | Background | Tegeler CH, Lee SW, Shaltout HA. Significance of right anterior insula activity for mental health intervention. JAMA Psychiatry. 2014 Mar;71(3):336. doi: 10.1001/jamapsychiatry.2013.3507. No abstract available. |
| 26347688 | Background | Gerdes L, Tegeler CH, Lee SW. A groundwork for allostatic neuro-education. Front Psychol. 2015 Aug 17;6:1224. doi: 10.3389/fpsyg.2015.01224. eCollection 2015. |
| 25136325 | Result | Lee SW, Gerdes L, Tegeler CL, Shaltout HA, Tegeler CH. A bihemispheric autonomic model for traumatic stress effects on health and behavior. Front Psychol. 2014 Aug 1;5:843. doi: 10.3389/fpsyg.2014.00843. eCollection 2014. |
| 25668305 | Result | Tegeler CH, Tegeler CL, Cook JF, Lee SW, Pajewski NM. Reduction in menopause-related symptoms associated with use of a noninvasive neurotechnology for autocalibration of neural oscillations. Menopause. 2015 Jun;22(6):650-5. doi: 10.1097/GME.0000000000000422. |
| 26085968 | Result | Tegeler CH, Shaltout HA, Tegeler CL, Gerdes L, Lee SW. Rightward dominance in temporal high-frequency electrical asymmetry corresponds to higher resting heart rate and lower baroreflex sensitivity in a heterogeneous population. Brain Behav. 2015 Jun;5(6):e00343. doi: 10.1002/brb3.343. Epub 2015 May 1. |
| 26645307 | Result | Fortunato JE, Tegeler CL, Gerdes L, Lee SW, Pajewski NM, Franco ME, Cook JF, Shaltout HA, Tegeler CH. Use of an allostatic neurotechnology by adolescents with postural orthostatic tachycardia syndrome (POTS) is associated with improvements in heart rate variability and changes in temporal lobe electrical activity. Exp Brain Res. 2016 Mar;234(3):791-8. doi: 10.1007/s00221-015-4499-y. Epub 2015 Dec 8. |
| 27747793 | Result | Tegeler CH, Tegeler CL, Cook JF, Lee SW, Gerdes L, Shaltout HA, Miles CM, Simpson SL. A Preliminary Study of the Effectiveness of an Allostatic, Closed-Loop, Acoustic Stimulation Neurotechnology in the Treatment of Athletes with Persisting Post-concussion Symptoms. Sports Med Open. 2016 Dec;2(1):39. doi: 10.1186/s40798-016-0063-y. Epub 2016 Sep 14. |
| 28420362 | Derived | Tegeler CH, Cook JF, Tegeler CL, Hirsch JR, Shaltout HA, Simpson SL, Fidali BC, Gerdes L, Lee SW. Clinical, hemispheric, and autonomic changes associated with use of closed-loop, allostatic neurotechnology by a case series of individuals with self-reported symptoms of post-traumatic stress. BMC Psychiatry. 2017 Apr 19;17(1):141. doi: 10.1186/s12888-017-1299-x. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Heart Rate Variability (SDNN) | Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval | BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats. | Posted | Mean | Standard Deviation | milliseconds | Up to 2 weeks after the intervention is completed |
|
|
|
| Primary | Baroreflex Sensitivity High Frequency (HF) Alpha | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats. | Posted | Mean | Standard Deviation | ms^2 | Baseline/Enrollment visit |
|
|
|
| Primary | Baroreflex Sensitivity High Frequency (HF) Alpha | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats. | Posted | Mean | Standard Deviation | ms^2 | Up to two weeks after the intervention is completed |
|
|
|
| Primary | Baroreflex Sensitivity Sequence Up | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats. | Posted | Mean | Standard Deviation | ms/mmHg | Baseline/Enrollment visit |
|
|
|
| Primary | Baroreflex Sensitivity Sequence Up | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats. | Posted | Mean | Standard Deviation | ms/mmHg | Up to two weeks after the intervention is completed |
|
|
|
| Primary | Baroreflex Sensitivity Sequence Down | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats. | Posted | Mean | Standard Deviation | ms/mmHg | Baseline/Enrollment visit |
|
|
|
| Primary | Baroreflex Sensitivity Sequence Down | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats. | Posted | Mean | Standard Deviation | ms/mmHg | Up to two weeks after the intervention is completed |
|
|
|
| Primary | Baroreflex Sensitivity Sequence All | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats. | Posted | Mean | Standard Deviation | ms/mmHg | Baseline/Enrollment visit |
|
|
|
| Primary | Baroreflex Sensitivity Sequence All | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats. | Posted | Mean | Standard Deviation | ms/mmHg | Up to 2 weeks after the intervention is completed |
|
|
|
| Secondary | Center for Epidemiologic Studies Depression Scale (CES-D) | The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology. | CES-D was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. | Posted | Mean | Standard Deviation | score on a scale | enrollment visit/baseline |
|
|
|
| Secondary | Center for Epidemiologic Studies Depression Scale (CES-D) | The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology. | CES-D was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks after intervention is completed |
|
|
|
| Secondary | Center for Epidemiologic Studies Depression Scale (CES-D) | The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology. | CES-D was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections. | Posted | Mean | Standard Deviation | score on a scale | 4-8 weeks after completion of the intervention |
|
|
|
| Secondary | Euro Quality of Life--Five Dimension (EQ-5D) | The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome. | EQ-5D was added as a study measure at subject 79. Entries were excluded if there was incomplete or missing data. | Posted | Mean | Standard Deviation | score on a scale | enrollment visit/baseline |
|
|
|
| Secondary | Euro Quality of Life--Five Dimension (EQ-5D) | The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome. | EQ-5D was added as a study measure at subject 79. Entries were excluded if there was incomplete or missing data. | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks after the intervention is completed |
|
|
|
| Secondary | Euro Quality of Life--Five Dimension (EQ-5D) | The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome. | EQ-5D was added as a study measure at subject 79. Entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections. | Posted | Mean | Standard Deviation | score on a scale | 4-8 weeks after completion of the intervention |
|
|
|
| Secondary | Generalized Anxiety Disorder-7 (GAD-7) | The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety. | GAD-7 was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. | Posted | Mean | Standard Deviation | score on a scale | enrollment visit/baseline |
|
|
|
| Secondary | Generalized Anxiety Disorder-7 (GAD-7) | The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety. | GAD-7 was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks after the intervention is completed |
|
|
|
| Secondary | Generalized Anxiety Disorder-7 (GAD-7) | The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety. | GAD-7 was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections. | Posted | Mean | Standard Deviation | score on a scale | 4-8 weeks after completion of the intervention |
|
|
|
| Secondary | Insomnia Severity Index (ISI) | The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality. | Entries were excluded if there was incomplete or missing data. | Posted | Mean | Standard Deviation | score on a scale | enrollment visit/baseline |
|
|
|
| Secondary | Insomnia Severity Index (ISI) | The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality. | Entries were excluded if there was incomplete or missing data. | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks after the intervention is completed |
|
|
|
| Secondary | Insomnia Severity Index (ISI) | The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality. | Entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections. | Posted | Mean | Standard Deviation | score on a scale | 4-8 weeks after completion of the intervention |
|
|
|
| Secondary | Posttraumatic Stress Disorder Checklist (PCL-C) | The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD. | Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported trauma or PTSD on medical history form. | Posted | Mean | Standard Deviation | score on a scale | enrollment visit/baseline |
|
|
|
| Secondary | Posttraumatic Stress Disorder Checklist (PCL) | The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD. | Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported trauma or PTSD on medical history form. | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks after the intervention is completed |
|
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| Secondary | Posttraumatic Stress Disorder Checklist (PCL) | The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD. | Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported trauma or PTSD on medical history form. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections. | Posted | Mean | Standard Deviation | score on a scale | 4-8 weeks after completion of the intervention |
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| Secondary | Rivermead Post-Concussion Symptoms Questionnaire (RPQ) | The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity. | Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported TBI or concussion on medical history form. | Posted | Mean | Standard Deviation | score on a scale | enrollment visit/baseline |
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| Secondary | Rivermead Post-Concussion Symptoms Questionnaire (RPQ) | The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with a higher score denoting the greatest symptom severity. | Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported TBI or concussion on medical history form. | Posted | Mean | Standard Deviation | score on a scale | 1-2 weeks after the intervention is completed |
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| Secondary | Rivermead Post-Concussion Symptoms Questionnaire (RPQ) | The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity. | Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported TBI or concussion on medical history form. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections. | Posted | Mean | Standard Deviation | score on a scale | 4-8 weeks after completion of the intervention |
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| Secondary | Drop Stick Reaction Testing | Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100. | Drop stick reaction testing was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. | Posted | Mean | Standard Deviation | cm | enrollment visit/baseline |
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| Secondary | Drop Stick Reaction Testing | Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100. | Drop stick reaction testing was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. | Posted | Mean | Standard Deviation | cm | 1-2 weeks after the intervention is completed |
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| Secondary | Drop Stick Reaction Testing | Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100. | Drop stick reaction testing was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections. | Posted | Mean | Standard Deviation | cm | 4-8 weeks after completion of the intervention |
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| Other Pre-specified | Heart Rate Variability Standard Deviation of NN Intervals (SDNN) | Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval | Not Posted | 4-8 weeks after completion of the intervention | Participants |
| Other Pre-specified | Baroreflex Sensitivity High Frequency (HF) Alpha | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | Not Posted | 4-8 weeks after completion of the intervention | Participants |
| Other Pre-specified | Baroreflex Sensitivity Sequence Up | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | Not Posted | 4-8 weeks after completion of the intervention | Participants |
| Other Pre-specified | Baroreflex Sensitivity Sequence Down | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | Not Posted | 4-8 weeks after completion of the intervention | Participants |
| Other Pre-specified | Baroreflex Sensitivity Sequence All | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. | Not Posted | 4-8 weeks after completion of the intervention | Participants |
| 0 |
| 300 |
| 0 |
| 300 |
| 0 |
| 300 |
Not provided
Not provided
Not provided
| D001523 |
| Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001924 | Brain Concussion |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |