Effects of Chiropractic Adjustments on Brain Function Using Quantitative Encephalography

April 19, 2016 updated by: Life University

Despite the abundance of theories concerning the effects of chiropractic adjustments on brain function, this remains an understudies area for the profession.

Quantitative Electroencephalography (qEEG)is a technique that allows for an in-depth analysis of brain function. A normative database will be used to compare before, during and after effects of chiropractic adjustments on brain function. This will include usage of Low Resolution Electromagnetic Tomography (LORETA).

This study seeks to objectively document effects of chiropractic adjustments on brain function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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, 30060
        • Life University

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

10 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be able to receive chiropractic adjustments

Exclusion Criteria:

  • No benzodiazepine class drugs in study participants
  • No use of medicines such as Sudafed (pseudoephedrine) or Nyquil (Doxylamine succinate)
  • At least 30 days since last chiropractic adjustment

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: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Placebo group
Ten people. Participants will receive what appears to be a chiropractic adjustment but which actually is not. This is the sham adjustment. Participants will also fill out Achenbach questionnaire. There will be a follow up in 7 days.
Other: Sham adjustment
Active Comparator: Chiropractic adjustment
Ten people. Group will be getting chiropractic adjustments. Participants will be filling out Achenbach questionnaire. There will be a follow up in 7 days.
Other: Chiropractic adjustment
No Intervention: Control group
Ten people. This group will simply have their EEG recorded at baseline and after 7 days. There will be an Achenbach questionnaire like the two other groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in quantitative EEG values as compared to a normative database
Time Frame: Baseline, during adjustment, after adjustment, follow up in 7 days

There will be a baseline measurement. There will be measurements during the adjustment. There will be measurements immediately after the adjustment. There will be measurements 7 days after the adjustment.

Data will then be analyzed comparing values to a normative database. This database is adjusted for age. This will generate z-score values in addition to raw EEG values. Statistical analysis of P-values will then be run to test significance of changes.
Baseline, during adjustment, after adjustment, follow up in 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral assessment questionaire
Time Frame: At baseline, one week after adjustment.
Subject will be asked to complete the Achenbach System of Empirically Based Assessment. This assessment asks questions about subjects adaptive and maladaptive functioning. This information is comparing the subject to other people their age.
At baseline, one week after adjustment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

June 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 23, 2013

First Submitted That Met QC Criteria

September 30, 2013

First Posted (Estimate)

October 1, 2013

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 19, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • I-0010

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.

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