Clinical trial NCT05245409: Stress, EEG, ECG, and Chiropractic
Official title: The Relationship Between Stress Scores, a Single-session of Chiropractic Care, Heart Rate Variability, and Electroencephalography Patterns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: stress, chiropractic, EEG, HRV
Lead sponsor: Life University
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Electroencephalography Power spectrum
timeFrame: Baseline (Pre)
measure: Electroencephalography Power spectrum
timeFrame: one-week (post)
measure: Auditory oddball task
timeFrame: Baseline (Pre)
measure: Auditory oddball task
timeFrame: one-week (post)
measure: Heart rate variability (HRV)
timeFrame: Baseline (Pre)
measure: Heart rate variability (HRV)
timeFrame: one-week (post)
measure: Weekly Stress Inventory Short Form
timeFrame: Baseline (Pre)
measure: Weekly Stress Inventory Short Form
timeFrame: one-week (post)
measure: Hamilton Anxiety Rating Scale
timeFrame: Baseline (pre)
measure: Hamilton Anxiety Rating Scale
timeFrame: one-week (post)
measure: Connor Davidson Resilience Scale - 25
timeFrame: baseline (pre)
measure: Connor Davidson Resilience Scale - 25
timeFrame: one-week (post)
measure: Severity of Acute Stress Symptoms
timeFrame: baseline (pre)
measure: Severity of Acute Stress Symptoms
timeFrame: one-week (post)
measure: Brief Resilience Scale
timeFrame: baseline (pre)
measure: Brief Resilience Scale
timeFrame: one-week (post)
measure: Daily Stress Scale
timeFrame: baseline (pre)
measure: Daily Stress Scale
timeFrame: one-week (post)
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Life University Center for Chiropractic Research
state: Georgia
Study officials:
affiliation: Life University Center for Chiropractic Research
name: Stephanie Sullivan, DC, PhD
role: STUDY_DIRECTOR
References: