Instantaneous EEG Changes Following Chiropractic Adjustment or Sham (INS)

August 27, 2024 updated by: Life University

Evaluation of Instantaneous Changes in EEG Activation Patterns Following Application of a Chiropractic Adjustment to the Cervical Spine

The project is a randomized, two-arm trial assessing the immediate impact of upper and lower cervical chiropractic adjustments on brain and heart patterns. Thirty individuals (15 per arm) will be recruited from the general population to participate in the study. Qualified participants will undergo a chiropractic physical exam, assessing for cervical subluxations, and a health history review with a Georgia licensed chiropractor. Individuals will be randomized to either an adjustment group or sham group. The adjustment group will receive an upper and lower cervical adjustment with an instrument designed to provide a gentle, targeted adjustment. The sham group will receive a touch sham at similar cervical locations with the same instrument. Both groups will have a 1-hour recording session with an EEG and ECG set-up plus a series of baseline recordings, interventions, and post recordings.

Study Overview

Status

Status

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

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 (Estimated)

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
      • Marietta, Georgia, United States, 30067
        • Dr. Sid E. Williams 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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Individuals between the ages of 18 and 50
  • Individuals who can wear an EEG net for 60 minutes Individuals who can sit quietly for at least 20 minutes
  • Individuals who can rest on their knees on a massage chair.
  • 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 two 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 20 minutes
  • Individuals who cannot rest on their knees on a massage chair.
  • 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 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 who may require x-rays. Since a single session of chiropractic care is being performed, if at any point the attending chiropractor has any concerns about the ability of the participant to tolerate care or require x-rays, the chiropractor will have the authority to remove the participant from the study.
  • Individuals who do not present with a subluxation in the upper cervical region (C1/C2) and in the lower cervical region (C3-C7). The attending chiropractor will determine the presence of the two subluxations during the chiropractic physical exam.
  • 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: Adjustment
Individuals with a subluxation who receive a true chiropractic adjustment
Procedure: Adjustment
Instrument-assisted, high velocity, low amplitude adjustment
Sham Comparator: Sham
Individuals with a subluxation who receive a light touch-only sham
Procedure: Sham
Instrument-assisted light touch to neck

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
EEG resting state effective connectivity
Time Frame: 0 minutes
Baseline EEG recording for the first intervention or sham procedure. A 64-channel hydronet will be on the head to capture EEG.
0 minutes
EEG resting state effective connectivity
Time Frame: 8 minutes
EEG recording immediately after the first intervention or sham procedure. A 64-channel hydronet will be on the head to capture EEG.
8 minutes
EEG resting state effective connectivity
Time Frame: 15 minutes
Baseline EEG recording for the second intervention or sham procedure. A 64-channel hydronet will be on the head to capture EEG.
15 minutes
EEG resting state effective connectivity
Time Frame: 23 minutes
EEG recording immediately after the second intervention or sham procedure. A 64-channel hydronet will be on the head to capture EEG.
23 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ECG R-R interval
Time Frame: 0 minutes
Baseline recording for the first intervention or sham procedure. Three leads will on the torso to capture a Lead II ECG.
0 minutes
ECG R-R interval
Time Frame: 8 minutes
ECG recording immediately after the first intervention or sham procedure. Three leads will on the torso to capture a Lead II ECG.
8 minutes
ECG R-R interval
Time Frame: 15 minutes
Baseline ECG recording for the second intervention or sham procedure. Three leads will on the torso to capture a Lead II ECG.
15 minutes
ECG R-R interval
Time Frame: 23 minutes
ECG recording immediately after the second intervention or sham procedure. Three leads will on the torso to capture a Lead II ECG.
23 minutes

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

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.
June 29, 2024

Primary Completion (Estimated)

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.
July 1, 2025

Study Completion (Estimated)

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.
December 16, 2025

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).
May 9, 2023

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.
May 9, 2023

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.
May 18, 2023

Study Record Updates

Last Update Posted (Actual)

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.
August 28, 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.
August 27, 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.
August 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-0024

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