Clinical trial NCT05864703: Instantaneous EEG Changes Following Chiropractic Adjustment or Sham
Official title: Evaluation of Instantaneous Changes in EEG Activation Patterns Following Application of a Chiropractic Adjustment to the Cervical Spine
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Subluxation
Keywords: Chiropractic
EEG
ECG
sham
Lead sponsor: Life University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, sham-controlled trial
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: EEG resting state effective connectivity
timeFrame: 0 minutes
measure: EEG resting state effective connectivity
timeFrame: 8 minutes
measure: EEG resting state effective connectivity
timeFrame: 15 minutes
measure: EEG resting state effective connectivity
timeFrame: 23 minutes
Secondary outcomes:
measure: ECG R-R interval
timeFrame: 0 minutes
measure: ECG R-R interval
timeFrame: 8 minutes
measure: ECG R-R interval
timeFrame: 15 minutes
measure: ECG R-R interval
timeFrame: 23 minutes
Other outcomes:
Locations:
city: Marietta
country: United States
facility: Dr. Sid E. Williams Center for Chiropractic Research
state: Georgia
Study officials:
affiliation: Life University
name: Stephanie Sullivan, DC, PhD
role: STUDY_DIRECTOR
References: