David Keyser(1), Chao Wang(1),(2), Paul Rapp(1), David Darmon(1),(2), Amy Trongnetrpunya(1),(2), David Nelson(3), Mary Lee Esty(4)
(1) Traumatic Injury Research Program, Department of Military and Emergency Medicine, Uniformed Services University, Bethesda, MD; (2) Henry M. Jackson Foundation, Bethesda, MD; (3) Department of Psychology and Philosophy, Sam Houston State University, Huntsville, TX, (4) Brain Wellness and Biofeedback Center, Bethesda, MD
Background: Relief of persistent post-concussive symptoms (PPCS) following trauma is a problem that is pervasive in active duty military personnel, veterans, and retirees. Several forms of treatment have been investigated with modest outcomes. Concurrent with these research efforts has been the search for physiological biomarkers for trauma. There is an urgent need to identify effective treatments for PPCS.
A physiological biomarker that can be measured through treatment may offer significant feedback to the provider as to the efficacy of any treatment. The Flexyx Neurotherapy System (FNS), licensed Dekares LLC technology, is a novel variant of electroencephalograph (EEG) biofeedback, was used to treat OEF/OIF personnel suffering from PPCS. Event-related potentials (ERP) were chosen as a potential neurophysiological biomarker. ERPs in response to a visual odd-ball protocol were recorded pre-FNS treatment and post-FNS treatment.
•14 OEF/OIF personnel (Active duty, reservists, civilian contractors) were consented for this USU and Chesapeake IRB approved study.
•Each participant reported to USU Traumatic Injury Research Program (TIRP) laboratory for electrophysiology assessment and self-report assessment.
Five validated assessment instruments were tested:
•SF-36 – Short Form 36 Item General Health Survey.
•SCL-90 – Symptom Checklist 90 general psychological screen.
•PCL – PTSD Checklist of symptoms.
•RPQ – Rivermead Post-concussion Questionnaire.
•PHQ-9 – Patient Health Questionnaire for depression.
Each instrument was administered Pre-FNS treatment and after completion of at least 20 FNS treatment sessions.
Visual Oddball Task (ERP):
•Each participant was prepped with a 6-lead EEG.
•The standard stimulus was a vertical line presented for 40 msec.
•The target line was a horizontal line presented for 40 msec.
•125 stimuli in total.
•The participants were instructed to maintain a silent count of the number of target stimulus presentations and to report their count at the end.
•A low-pass filter at 8 Hz was applied to remove alpha residuals.
•P300 amplitude was measured as the voltage of the largest positive peak of target ERP within 250-500 msec relative to stimulus onset.
•P300 latency was measured as the time of P300 peak.
A.Patient self-report symptom severity scores before and after treatment. All the scores including SF-36, SCL-90, PHQ-9, Rivermead, and PCL were significantly improved (p ≤ 0.001) at the post-treatment assessment compared to baseline. The sample size for SF-36, SCL-90, PHQ-9, and PCL is n =14. The sample size for Rivermead is n = 11 because of missing data. For SF-36, SCL-90, PHQ-9 and Rivermead, the data were obtained on the same day of EEG recording. For PCL, the data were obtained on the first day of treatment before treatment starts (pre-treatment) and on the day after completed about 20 treatment sessions (post-treatment).
Each score plotted in the figure is normalized into 0 to 1 by dividing its possible maximum value. For SCL-90, PHQ-9, Rivermead, and PCL, a high score indicates high severity of the symptoms. For SF-36, a high score indicated low severity of the symptoms. To make a consistent visualization, we used the inverted SF-36 score (100 minus SF-36) in the plot so that all the scores are in the same direction. Shaded areas indicate the 95% confidence interval.
B. Grand-average ERPs (n = 14) from electrode Pz for pre- and post-treatment. Post-treatment ERP showed increased P300 amplitude and shortened P300 latency compared to pre-treatment. Statistical tests using random permutation (5000 times) on pre/post conditions suggest that the shortened P300 latency (p < 0.0001) is significant but the increased P300 amplitude is not significant (p = 0.21).
Each of the five assessment instruments exhibited statistically significant shifts in a positive direction (p < 0.001). The peak latency of the P-300 ERP component recorded at Pz also exhibited a statistically significant shortening (p < 0.0001). While the peak amplitude also increased, it was not statistically significant (p = 0.21).
Five validated assessment instruments showed improvement in a pilot study of fourteen individuals after treatment with FNS, a Dekares LLC licensed technology, indicating that FNS may be an effective treatment for PPCS. The P-300 is a candidate neuro-marker for improved brain function in individuals suffering from PPCS. Further testing is warranted.
This research was supported in part by the Traumatic Injury Research Program of the Uniformed Services University of the Health Sciences, the Marine Corps Systems Command, and the Defense Medical Research and Development Program (USU/TIRP) and the Brain Wellness Fund (BWB Ctr). The opinions and assertions contained herein are the private opinions of the authors and are not to be construed as official or reflecting the views of their respective commands, the US Navy, the US Army, or the Department of Defense. ML Esty is owner/operator of the BWB Ctr. and licensee of the technology used in FNS. None of the other authors nor their family members have a financial interest in any commercial product, service, or organization providing financial support for this research.
BACKGROUND: Chronic headache following traumatic brain injury (TBI) sustained in military service, while common, is highly challenging to treat with existing pharmacologic and non-pharmacologic interventions and may be complicated by co-morbid post-traumatic stress. Recently, a novel form of brainwave-based intervention known as the Flexyx Neurotherapy System (FNS), now known as NeuroRecalibration, that involves minute pulses of electromagnetic energy stimulation of brainwave activity has been suggested as a means to address symptoms of TBI. This study reports on a clinical series of patients with chronic headache following service-connected TBI treated with FNS.
RESULTS: All beginning to end of treatment t-test comparisons for the BPI-HA, PCL-M, and cognitive dysfunction NRS indicated statistically significant decreases. All but one participant experienced reduction in headaches along with reductions in posttraumatic stress and perceived cognitive dysfunction, with a subset experiencing virtual elimination of headaches. One of the nine participants in this study did not report any symptom improvement; and another did not report improvement in post-traumatic stress symptoms or cognitive dysfunction, although he did experience some reduction in headache intensity ratings down to low moderate/mild levels.
CONCLUSIONS: FNS may be a potentially efficacious treatment for chronic post-traumatic headache sustained in military service. Further research is needed to investigate the efficacy of FNS within a randomized, controlled clinical trial, to identify characteristics of those most likely to respond, and to explore underlying mechanisms that may contribute to improvement.
(Nelson, D. V., and M. L. Esty (2015). "Neurotherapy for chronic headache following traumatic brain injury" Military Medical Research, 2:22. DOI 10.1186/s40779-015-0049-y)
Of the seven, five completed the study, with two dropping out after significant symptom reduction. The Flexyx Neurotherapy System (FNS), a novel variant of EEG biofeedback, now known as NeuroRecalibration, was adapted for intervention with seven treatment-refractory Afghanistan/Iraq war veterans, and brought about significant decreases on four NFI dimensions and strong trends on the other two, and significant decreases in PSS Total scores as well as the re- experiencing and avoidance symptoms clusters and a strong trend in evidence for decrease in arousal symptoms. FNS may help ameliorate mixed trauma spectrum syndromes.*These veterans were also part of the 2015 study subject pool.
(Nelson, D. V., and M. L. Esty. "Neurotherapy of Traumatic Brain Injury/Post-traumatic Stress Symptoms in OEF/OIF Veterans." J Neuropsychiatry Clin Neurosci 24, no. 2 (Spring 2012): 237-40.) *These veterans were also part of the 2015 study subject pool.
There is a critical need to develop more effective treatments to reduce the morbidity associated with persistently bothersome symptoms following traumatic brain injury (TBI). Recent developments within the bio-energy domain of complementary and alternative medicine
Complementary and alternative medicine (CAM) utilizing EEG information have suggested some promise for application to TBI. A novel approach known as the Flexyx Neurotherapy System (FNS), now known as NeuroRecalibration, that involves minute pulses of electromagnetic (EM) energy to stimulate changes in brainwave patterns has been adapted for this purpose. The present study reports on a series of patients seen in a clinical practice who underwent this intervention as an initial step in documenting the potential promise of this approach. Results Curve estimation regression analyses indicated linear trends in evidence for significant decreases in all bothersome symptom ratings over the course of treatment sessions, including attention (beta = -.13; R2 = 0.14, F[1,227] = 37.31, P< .001), other cognitive problems (beta = - 0.17; R2 = 0.24, F[1,333] = 104.46, P = .001), difficulty following conversations (beta = -.07, R2 = .07, F[1,107], P =.005), fatigue (beta =-0.13; R2 = 0.16, F[1,296] = 57.49, P < .001), headache (beta = -.21; R2 = .24, F[1,100] =31.66, P < .001), anger (beta = -.24; R2 = .47, F[1,177] = 160.20, P < .001), anxiety (beta= -.20; R2 = .22, F[1,387] = 107.12, P < .001), mood swings (beta = -.05; R2 = .02, F[1,237]= 4.69, P = .03), motivation problems (beta = -.10; R2 = .06, F[1,228] = 14.94, P < .001), and sleep disturbance (beta = -.12; R2 = .08, F[1,264] = 8.41, P = .005). Reported side effects were minimal.
(Nelson, D. V., and M.L. Esty. "Neurotherapy for TBI: A CAM Intervention." 2010, Brain Injury. Vol. 24 (3) 366. March.)
Previous report suggested the beneficial effects of an adaptation of the Flexyx Neurotherapy System (FNS), now known as NeuroRecalibration, for the amelioration of mixed traumatic brain injury/post-traumatic stress symptoms in veterans of the Afghanistan and Iraq wars. As a novel variant of electroencephalograph biofeedback, FNS falls within the bioenergy domain of complementary and alternative medicine. Rather than learning voluntary control over the production/inhibition of brain wave patterns,
FNS involves offsetting stimulation of brain wave activity by means of an external energy source, specifically, the conduction of electromagnetic energy stimulation via the connecting electroencephalograph cables. Essentially, these procedures subliminally induce strategic distortion of ongoing brain wave activity to presumably facilitate resetting of more adaptive patterns of activity. Reported herein are two cases of Vietnam veterans with mixed traumatic brain injury/post-traumatic stress symptoms, each treated with FNS for 25 sessions.
Comparisons of pre- and post-treatment questionnaire assessments revealed notable decreases for all symptoms, suggesting improvements across the broad domains of cognition, pain, sleep, fatigue, and mood/emotion, including post-traumatic stress symptoms, as well as for overall activity levels.
Findings suggest FNS treatment may be of potential benefit for the partial amelioration of symptoms, even in some individuals for whom symptoms have been present for decades.
(Nelson, D. V., and M. L. Esty. "Neurotherapy for Chronic TBI/PTSD Symptoms in Vietnam Veterans." Journal of Head Trauma Rehabilitation 24, no. 5 (Sep-Oct 2009): 403-03; study fully published in 2015: Nelson, D. V., and M. L. Esty. "Neurotherapy of Traumatic Brain Injury/Post-Traumatic Stress Symptoms in Vietnam Veterans." Mil Med 180, no. 10 (Oct 2015): e1111-4.)
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