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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01953614
Other study ID # I-0010
Secondary ID
Status Completed
Phase N/A
First received August 23, 2013
Last updated April 19, 2016
Start date June 2013
Est. completion date December 2015

Study information

Verified date April 2016
Source Life University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 10 Years to 99 Years
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Other:
Chiropractic adjustment

Sham adjustment


Locations

Country Name City State
United States Life University Marietta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Life University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in quantitative EEG values as compared to a normative database 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 No
Secondary Behavioral assessment questionaire 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. No
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