Effects of Chiropractic Adjustments on Brain Function Using Quantitative Encephalography

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Life University
Sponsor:
Information provided by (Responsible Party):
Life University
ClinicalTrials.gov Identifier:
NCT01953614
First received: August 23, 2013
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Brain Function
Other: Chiropractic adjustment
Other: Sham adjustment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Effects of Chiropractic Adjustments on Brain Function Using Quantitative Encephalography

Further study details as provided by Life University:

Primary Outcome Measures:
  • Changes in quantitative EEG values as compared to a normative database [ Time Frame: Baseline, during adjustment, after adjustment, follow up in 7 days ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Behavioral assessment questionaire [ Time Frame: At baseline, one week after adjustment. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: June 2013
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01953614

Locations
United States, Georgia
Life University Recruiting
Marietta, Georgia, United States, 30060
Contact: Stephanie Sullivan, Doctor of Chiropractic    770-426-2632    stephanie.sullivan@life.edu   
Principal Investigator: Daniel M Tuttle, Masters of Social Work         
Principal Investigator: Jerry I Hochman, Doctor of Chiropractic         
Sponsors and Collaborators
Life University
  More Information

No publications provided

Responsible Party: Life University
ClinicalTrials.gov Identifier: NCT01953614     History of Changes
Other Study ID Numbers: I-0010
Study First Received: August 23, 2013
Last Updated: September 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Life University:
quantitative encephalography
brain computer interface
chiropractic
sacro-occipital technique

ClinicalTrials.gov processed this record on August 28, 2014