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Completed

NCT Number: NCT05245409

Stress, EEG, ECG, and Chiropractic

The Life University Center for Chiropractic Research is conducting a study to better understand the relationship between subjective stress measures and brain patterns during resting state and an auditory oddball task. A secondary aim is to evaluate the impact of a single session of chiropractic care on the resting state and P300 time locked response after a one-week wait period. An additional outcome assessment for this study will be the recording of an electrocardiogram (ECG) of each participant that will be used to analyze their heart rate variability (HRV). Eligible individuals will receive a physical exam to ensure safety during all procedures. They will then sit for a 6-minute resting state EEG and an auditory oddball task. They will complete a series of questionnaires assessing stress. They will receive a chiropractic adjustment using a handheld instrument called an Activator. They will return one week later for a follow-up assessment consisting of the 6-minute resting state EEG, auditory oddball task, and the questionnaires assessing stress.

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Key information

Conditions

Stress

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Life University Center for Chiropractic Research

Atlanta, Georgia, 30308, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals between the ages of 18 and 40
  • Individuals who can wear an EEG cap for 40 minutes
  • Individuals who can sit quietly for at least 15 minutes
  • Individuals who have not had a chiropractic adjustment within the last two weeks
  • Individuals who have not received any other interventions, such as osteopathic spinal manipulation, physical therapy rehabilitation or manipulation, massage, body movement therapies or acupuncture within the last 2 weeks.

Exclusion criteria

  • Individuals who have been diagnosed with a serious mental disorder such as schizophrenia or major depressive disorder that could influence EEG results
  • Individuals who do not feel they can sit quietly with limited movement for roughly 15 minutes
  • Individuals who are on psychotropic medications (e.g. Benzodiazepine medications) that influence EEG readings (Benzodiazepine medications include but are not limited to: alprazolam, chlordiazepoxide, clobazam, clonazepam, clorazepate, diazepam, estazolam, flurazepam, lorazepam, midazolam, oxazepam, temazepam, triazolam, etc.)
  • Individuals with any injury or surgery to the skull in the last 6 months, or a history of trauma to the head such as a concussion or stroke
  • Individuals with a hearing impairment (due to the auditory stimulus recording being performed)
  • Individuals who are currently pregnant
  • Individuals with a current litigation related to a physical, health-related injury
  • Individuals with untreated diagnosed osteoporosis or articular instability, such as atlanto-axial instability
  • Individuals with a known heart condition that results in an aberrant ECG recording

Treatment and study plan

Chiropractic adjustment using an activator

Other

Chiropractic adjustment using an activator

Primary outcomes

  1. Electroencephalography Power spectrum

    Time frame: Baseline (Pre)

    6 minutes of resting state EEG with eyes closed. 64 channels of EEG will be recorded. A fast Fourier transform will be computed to provide a power spectrum of frequencies 1-50.

  2. Electroencephalography Power spectrum

    Time frame: one-week (post)

    6 minutes of resting state EEG with eyes closed. 64 channels of EEG will be recorded. A fast Fourier transform will be computed to provide a power spectrum of frequencies 1-50.

  3. Auditory oddball task

    Time frame: Baseline (Pre)

    Auditory oddball task with 200 common and 40 rare stimuli. P300 evoked related potential evaluated through capturing EEG.

  4. Auditory oddball task

    Time frame: one-week (post)

    Auditory oddball task with 200 common and 40 rare stimuli. P300 evoked related potential evaluated through capturing EEG.

  5. Heart rate variability (HRV)

    Time frame: Baseline (Pre)

    ECG recording will be used to evaluate HRV from R-R intervals.

  6. Heart rate variability (HRV)

    Time frame: one-week (post)

    ECG recording will be used to evaluate HRV from R-R intervals.

  7. Weekly Stress Inventory Short Form

    Time frame: Baseline (Pre)

    25 questions. Likert scale: did not happen; happended but not successful; slightly stressful; mildly stressful; moderately stressful; stressful; very stressful; extremely stressful.

  8. Weekly Stress Inventory Short Form

    Time frame: one-week (post)

    25 questions. Likert scale: did not happen; happended but not successful; slightly stressful; mildly stressful; moderately stressful; stressful; very stressful; extremely stressful.

  9. Hamilton Anxiety Rating Scale

    Time frame: Baseline (pre)

    14 questions. Likert scale: not true at all; rarely true; sometimes true; often true; true nearly all the time.

  10. Hamilton Anxiety Rating Scale

    Time frame: one-week (post)

    14 questions. Likert scale: not true at all; rarely true; sometimes true; often true; true nearly all the time.

  11. Connor Davidson Resilience Scale - 25

    Time frame: baseline (pre)

    25 questions. Likert scale: not true at all; rarely true; sometimes true; often true; true nearly all the time.

  12. Connor Davidson Resilience Scale - 25

    Time frame: one-week (post)

    25 questions. Likert scale: not true at all; rarely true; sometimes true; often true; true nearly all the time.

  13. Severity of Acute Stress Symptoms

    Time frame: baseline (pre)

    7 questions. Likert scale: never; almost never; sometimes; fairly often; very often.

  14. Severity of Acute Stress Symptoms

    Time frame: one-week (post)

    7 questions. Likert scale: never; almost never; sometimes; fairly often; very often.

  15. Brief Resilience Scale

    Time frame: baseline (pre)

    6 questions. Likert scale: strongly disagree; disagree; neutral; agree; strongly agree

  16. Brief Resilience Scale

    Time frame: one-week (post)

    6 questions. Likert scale: strongly disagree; disagree; neutral; agree; strongly agree

  17. Daily Stress Scale

    Time frame: baseline (pre)

    6 questions. Numeric rating scale from 0-10. O indicating no stress and 10 indicating extremly stressful.

  18. Daily Stress Scale

    Time frame: one-week (post)

    6 questions. Numeric rating scale from 0-10. O indicating no stress and 10 indicating extremly stressful.

Sponsors and collaborators

Lead sponsor

Life University

Other

Registry information

Official study title

The Relationship Between Stress Scores, a Single-session of Chiropractic Care, Heart Rate Variability, and Electroencephalography Patterns

Acronym: BLI

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 18, 2022
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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