Stress, EEG, ECG, and Chiropractic

Stress Clinical Trial

— BLI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05245409
• Other study ID #: I-0016
• Status: Completed
• Phase: N/A
• Start date: September 28, 2021
• Est. completion date: June 2, 2023

Study information

• Verified date: February 2024
• Source: Life University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2, 2023
• Est. primary completion date: June 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress

Intervention

Other:
• Chiropractic adjustment using an activator
Chiropractic adjustment using an activator

Locations

Country	Name	City	State
United States	Life University Center for Chiropractic Research	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Life University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (Pre)
Primary	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.	one-week (post)
Primary	Auditory oddball task	Auditory oddball task with 200 common and 40 rare stimuli. P300 evoked related potential evaluated through capturing EEG.	Baseline (Pre)
Primary	Auditory oddball task	Auditory oddball task with 200 common and 40 rare stimuli. P300 evoked related potential evaluated through capturing EEG.	one-week (post)
Primary	Heart rate variability (HRV)	ECG recording will be used to evaluate HRV from R-R intervals.	Baseline (Pre)
Primary	Heart rate variability (HRV)	ECG recording will be used to evaluate HRV from R-R intervals.	one-week (post)
Primary	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.	Baseline (Pre)
Primary	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.	one-week (post)
Primary	Hamilton Anxiety Rating Scale	14 questions. Likert scale: not true at all; rarely true; sometimes true; often true; true nearly all the time.	Baseline (pre)
Primary	Hamilton Anxiety Rating Scale	14 questions. Likert scale: not true at all; rarely true; sometimes true; often true; true nearly all the time.	one-week (post)
Primary	Connor Davidson Resilience Scale - 25	25 questions. Likert scale: not true at all; rarely true; sometimes true; often true; true nearly all the time.	baseline (pre)
Primary	Connor Davidson Resilience Scale - 25	25 questions. Likert scale: not true at all; rarely true; sometimes true; often true; true nearly all the time.	one-week (post)
Primary	Severity of Acute Stress Symptoms	7 questions. Likert scale: never; almost never; sometimes; fairly often; very often.	baseline (pre)
Primary	Severity of Acute Stress Symptoms	7 questions. Likert scale: never; almost never; sometimes; fairly often; very often.	one-week (post)
Primary	Brief Resilience Scale	6 questions. Likert scale: strongly disagree; disagree; neutral; agree; strongly agree	baseline (pre)
Primary	Brief Resilience Scale	6 questions. Likert scale: strongly disagree; disagree; neutral; agree; strongly agree	one-week (post)
Primary	Daily Stress Scale	6 questions. Numeric rating scale from 0-10. O indicating no stress and 10 indicating extremly stressful.	baseline (pre)
Primary	Daily Stress Scale	6 questions. Numeric rating scale from 0-10. O indicating no stress and 10 indicating extremly stressful.	one-week (post)