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

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Life University

Investigators

  • 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)

June 29, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

December 16, 2025

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID 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.

Subscribe