Stress, EEG, ECG, and Chiropractic

NCT ID: NCT05245409

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2023-06-02

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.

Conditions

Stress

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Stress

Individuals under various degrees of stress

Group Type: EXPERIMENTAL

Chiropractic adjustment using an activator

Intervention Type: OTHER

Chiropractic adjustment using an activator

Interventions

Chiropractic adjustment using an activator

Chiropractic adjustment using an activator

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Life University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Sullivan, DC, PhD

Role: STUDY_DIRECTOR

Life University Center for Chiropractic Research

Locations

Life University Center for Chiropractic Research

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

I-0016

Identifier Type: -

Identifier Source: org_study_id