Evidence map›Paper›PMID 29502530›Full record

Trial reportMilitary Medical Research2017

Successful use of closed-loop allostatic neurotechnology for post-traumatic stress symptoms in military personnel: self-reported and autonomic improvements.

Catherine L Tegeler, Lee Gerdes, Hossam A Shaltout, Jared F Cook, Sean L Simpson, Sung W Lee, Charles H Tegeler

5 registry-linked trialsOpen access · diamondAbstract readClinical Trial
In one paragraph

Trial report in Military Medical Research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
1.6field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03230890 nacompletednot on this map

HIRREM for Mitigation of PTSD Symptoms in Military Personnel

TypeinterventionalSponsorWake Forest University Health SciencesRan2015 to 2021Enrolled32ConditionsStress Disorders, Post-TraumaticArmsHIRREM
NCT03777267 narecruitingnot on this mapstarted 2019, after this paper: background citation

Cereset Research Exploratory Study

TypeinterventionalSponsorWake Forest University Health SciencesRan2019 to 2028Enrolled200ConditionsNeurological Diseases or Conditions, Cardiovascular Conditions After Birth, Psychophysiologic DisordersArmsActive CR
NCT04682197 nacompletednot on this mapstarted 2021, after this paper: background citation

Cereset Research To Reduce Stress In Healthcare Workers In The Time Of COVID-19

TypeinterventionalSponsorWake Forest University Health SciencesRan2021 to 2023Enrolled144ConditionsHealth Personnel, Stress, Anxiety, InsomniaArmsCereset Research
NCT05209438 narecruitingnot on this mapstarted 2022, after this paper: background citation

Cereset Research for Caregivers: A Randomized, Controlled Trial

TypeinterventionalSponsorWake Forest University Health SciencesRan2022 to 2027Enrolled20ConditionsCaregiversArmsCereset Research
NCT05229107 nawithdrawnnot on this mapstarted 2024, after this paper: background citation

Randomized Controlled Pilot Trial of Cereset Research For Chronic Nausea

TypeinterventionalSponsorWake Forest University Health SciencesRan2024 to 2024Enrolled0ConditionsNausea, Gastroparesis, Stress, AnxietyArmsCereset Research
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Review
  15. Review
  16. Article
  17. Article
  18. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Catherine L TegelerDepartment of Neurology, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC, 27157, USA.
Lee GerdesBrain State Technologies, LLC, 15150 North Hayden Road, Scottsdale, AZ, 85260, USA.
Hossam A ShaltoutHypertension and Vascular Research Center, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC, 27157, USA.
Jared F CookDepartment of Neurology, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC, 27157, USA.
Sean L SimpsonDepartment of Biostatistical Sciences, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC, 27157, USA.
Sung W LeeBrain State Technologies, LLC, 15150 North Hayden Road, Scottsdale, AZ, 85260, USA.
Charles H TegelerDepartment of Neurology, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC, 27157, USA. ctegeler@wakehealth.edu.
Wake Forest University · US

Funding

Statistical Methods for Whole-Brain Connectivety NetworksK25EB012236 · NIBIB · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI SIMPSON, SEAN L · 2012 to 2016
$796k
Joint Capability Technology Demonstration Program within the Office of the Under Secretary of Defense (Acquisition, Technology, and Logistics) via a contract with the U.S. Special Operations Command H92222-14-P-0012NIBIB NIH HHS K25 EB012236-01A1
6 · The paper itself

Abstract

backgroundMilitary-related post-traumatic stress (PTS) is associated with numerous symptom clusters and diminished autonomic cardiovascular regulation. High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®) is a noninvasive, closed-loop, allostatic, acoustic stimulation neurotechnology that produces real-time translation of dominant brain frequencies into audible tones of variable pitch and timing to support the auto-calibration of neural oscillations. We report clinical, autonomic, and functional effects after the use of HIRREM® for symptoms of military-related PTS.

methodsEighteen service members or recent veterans (15 active-duty, 3 veterans, most from special operations, 1 female), with a mean age of 40.9 (SD = 6.9) years and symptoms of PTS lasting from 1 to 25 years, undertook 19.5 (SD = 1.1) sessions over 12 days. Inventories for symptoms of PTS (Posttraumatic Stress Disorder Checklist - Military version, PCL-M), insomnia (Insomnia Severity Index, ISI), depression (Center for Epidemiologic Studies Depression Scale, CES-D), and anxiety (Generalized Anxiety Disorder 7-item scale, GAD-7) were collected before (Visit 1, V1), immediately after (Visit 2, V2), and at 1 month (Visit 3, V3), 3 (Visit 4, V4), and 6 (Visit 5, V5) months after intervention completion. Other measures only taken at V1 and V2 included blood pressure and heart rate recordings to analyze heart rate variability (HRV) and baroreflex sensitivity (BRS), functional performance (reaction and grip strength) testing, blood and saliva for biomarkers of stress and inflammation, and blood for epigenetic testing. Paired t-tests, Wilcoxon signed-rank tests, and a repeated-measures ANOVA were performed.

resultsClinically relevant, significant reductions in all symptom scores were observed at V2, with durability through V5. There were significant improvements in multiple measures of HRV and BRS [Standard deviation of the normal beat to normal beat interval (SDNN), root mean square of the successive differences (rMSSD), high frequency (HF), low frequency (LF), and total power, HF alpha, sequence all, and systolic, diastolic and mean arterial pressure] as well as reaction testing. Trends were seen for improved grip strength and a reduction in C-Reactive Protein (CRP), Angiotensin II to Angiotensin 1-7 ratio and Interleukin-10, with no change in DNA n-methylation. There were no dropouts or adverse events reported.

conclusionsService members or veterans showed reductions in symptomatology of PTS, insomnia, depressive mood, and anxiety that were durable through 6 months after the use of a closed-loop allostatic neurotechnology for the auto-calibration of neural oscillations. This study is the first to report increased HRV or BRS after the use of an intervention for service members or veterans with PTS. Ongoing investigations are strongly warranted.

trial registrationNCT03230890 , retrospectively registered July 25, 2017.

Indexed as

Self ReportAdultAllostasisAngiotensin IAngiotensin IIBiomarkersC-Reactive ProteinElectroencephalographyEpinephrineHeart RateHumansInterleukin-1Interleukin-10Interleukin-6MaleMiddle AgedAngiotensin Iangiotensin I (1-7)Angiotensin IIBiomarkersC-Reactive ProteinEpinephrineIL10 protein, humanIL6 protein, humanInterleukin-1Interleukin-10Interleukin-6NorepinephrinePeptide FragmentsVasopressinsAcoustic stimulationAllostasisAutonomicBaroreflex sensitivityClosed-loopHeart rate variabilityHIRREMMilitaryNeurotechnologyPost-traumatic stress disorder

Identifiers

PMID29502530
PMCPMC5740870
OpenAlexW2776019393

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.