StressBLINCT05245409
Stress, EEG, ECG, and Chiropractic
A study testing Chiropractic adjustment using an activator in people with Stress, run by Life University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Chiropractic adjustment using an activator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2021to 2 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Life University Center for Chiropractic Research
Atlanta, Georgia, 30308
About this study
Official title: 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.
- Conditions
- Stress
- Being tested
- Chiropractic adjustment using an activator
- Keywords
- stress, chiropractic, EEG, HRV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic adjustment using an activatorOther
Chiropractic adjustment using an activator
| Study group | Role | What they receive |
|---|---|---|
| Stress | Experimental | Individuals under various degrees of stress Receives: Other: Chiropractic adjustment using an activator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalography Power spectrum
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.
Measured: Baseline (Pre)
Electroencephalography Power spectrum
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.
Measured: one-week (post)
Auditory oddball task
Auditory oddball task with 200 common and 40 rare stimuli. P300 evoked related potential evaluated through capturing EEG.
Measured: Baseline (Pre)
Auditory oddball task
Auditory oddball task with 200 common and 40 rare stimuli. P300 evoked related potential evaluated through capturing EEG.
Measured: one-week (post)
Heart rate variability (HRV)
ECG recording will be used to evaluate HRV from R-R intervals.
Measured: Baseline (Pre)
Heart rate variability (HRV)
ECG recording will be used to evaluate HRV from R-R intervals.
Measured: one-week (post)
Weekly Stress Inventory Short Form
25 questions. Likert scale: did not happen; happended but not successful; slightly stressful; mildly stressful; moderately stressful; stressful; very stressful; extremely stressful.
Measured: Baseline (Pre)
Weekly Stress Inventory Short Form
25 questions. Likert scale: did not happen; happended but not successful; slightly stressful; mildly stressful; moderately stressful; stressful; very stressful; extremely stressful.
Measured: one-week (post)
Hamilton Anxiety Rating Scale
14 questions. Likert scale: not true at all; rarely true; sometimes true; often true; true nearly all the time.
Measured: Baseline (pre)
Hamilton Anxiety Rating Scale
14 questions. Likert scale: not true at all; rarely true; sometimes true; often true; true nearly all the time.
Measured: one-week (post)
Connor Davidson Resilience Scale - 25
25 questions. Likert scale: not true at all; rarely true; sometimes true; often true; true nearly all the time.
Measured: baseline (pre)
Connor Davidson Resilience Scale - 25
25 questions. Likert scale: not true at all; rarely true; sometimes true; often true; true nearly all the time.
Measured: one-week (post)
Severity of Acute Stress Symptoms
7 questions. Likert scale: never; almost never; sometimes; fairly often; very often.
Measured: baseline (pre)
Severity of Acute Stress Symptoms
7 questions. Likert scale: never; almost never; sometimes; fairly often; very often.
Measured: one-week (post)
Brief Resilience Scale
6 questions. Likert scale: strongly disagree; disagree; neutral; agree; strongly agree
Measured: baseline (pre)
Brief Resilience Scale
6 questions. Likert scale: strongly disagree; disagree; neutral; agree; strongly agree
Measured: one-week (post)
Daily Stress Scale
6 questions. Numeric rating scale from 0-10. O indicating no stress and 10 indicating extremly stressful.
Measured: baseline (pre)
Daily Stress Scale
6 questions. Numeric rating scale from 0-10. O indicating no stress and 10 indicating extremly stressful.
Measured: one-week (post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start28 Sep 2021
- Primary completion2 Jun 2023
- Study completion2 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Life University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Sullivan, DC, PhD, Study director, Life University Center for Chiropractic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245409
- Sponsor's protocol ID
- I-0016
- Acronym
- BLI
- Status last verified
- Feb 2024
- First submitted
- 27 Jan 2022
- Last updated
- 2 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Stress Scores, a Single-session of Chiropractic Care, Heart Rate Variability, and Electroencephalography Patterns
- ClinicalTrials.gov ID
- NCT05245409
- Acronym / sponsor ID
- BLI / I-0016
- Conditions
- Stress
- Keywords
- stress, chiropractic, EEG, HRV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Life UniversityUniversity, hospital or other
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stress | Experimental | Other: Chiropractic adjustment using an activatorIndividuals under various degrees of stress |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chiropractic adjustment using an activatorChiropractic adjustment using an activator | Other | Stress |
Primary outcome
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.
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.
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.
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.
Heart rate variability (HRV)
Time frame: Baseline (Pre)
ECG recording will be used to evaluate HRV from R-R intervals.
Heart rate variability (HRV)
Time frame: one-week (post)
ECG recording will be used to evaluate HRV from R-R intervals.
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.
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.
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.
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.
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.
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.
Severity of Acute Stress Symptoms
Time frame: baseline (pre)
7 questions. Likert scale: never; almost never; sometimes; fairly often; very often.
Severity of Acute Stress Symptoms
Time frame: one-week (post)
7 questions. Likert scale: never; almost never; sometimes; fairly often; very often.
Brief Resilience Scale
Time frame: baseline (pre)
6 questions. Likert scale: strongly disagree; disagree; neutral; agree; strongly agree
Brief Resilience Scale
Time frame: one-week (post)
6 questions. Likert scale: strongly disagree; disagree; neutral; agree; strongly agree
Daily Stress Scale
Time frame: baseline (pre)
6 questions. Numeric rating scale from 0-10. O indicating no stress and 10 indicating extremly stressful.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Sullivan, DC, PhD study director
Life University Center for Chiropractic Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic adjustment using an activator in people with Stress, run by Life University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalography Power spectrum (time frame: Baseline (Pre)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.