Stress, EEG, ECG, and Chiropractic (BLI)

February 1, 2024 updated by: Life University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Life University Center for Chiropractic Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Stress
Individuals under various degrees of stress
Other: Chiropractic adjustment using an activator
Chiropractic adjustment using an activator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (Pre)
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.
one-week (post)
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.
Baseline (Pre)
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.
one-week (post)
Heart rate variability (HRV)
Time Frame: Baseline (Pre)
ECG recording will be used to evaluate HRV from R-R intervals.
Baseline (Pre)
Heart rate variability (HRV)
Time Frame: one-week (post)
ECG recording will be used to evaluate HRV from R-R intervals.
one-week (post)
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.
Baseline (Pre)
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.
one-week (post)
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.
Baseline (pre)
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.
one-week (post)
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.
baseline (pre)
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.
one-week (post)
Severity of Acute Stress Symptoms
Time Frame: baseline (pre)
7 questions. Likert scale: never; almost never; sometimes; fairly often; very often.
baseline (pre)
Severity of Acute Stress Symptoms
Time Frame: one-week (post)
7 questions. Likert scale: never; almost never; sometimes; fairly often; very often.
one-week (post)
Brief Resilience Scale
Time Frame: baseline (pre)
6 questions. Likert scale: strongly disagree; disagree; neutral; agree; strongly agree
baseline (pre)
Brief Resilience Scale
Time Frame: one-week (post)
6 questions. Likert scale: strongly disagree; disagree; neutral; agree; strongly agree
one-week (post)
Daily Stress Scale
Time Frame: baseline (pre)
6 questions. Numeric rating scale from 0-10. O indicating no stress and 10 indicating extremly stressful.
baseline (pre)
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.
one-week (post)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Life University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Stephanie Sullivan, DC, PhD, Life University Center for Chiropractic Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 2, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 2, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • I-0016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings