SubluxationINSNCT05864703
Instantaneous EEG Changes Following Chiropractic Adjustment or Sham
A study testing Adjustment in people with Subluxation, run by Life University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Subluxation
- What is being tested?
- Adjustment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2024to 16 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dr. Sid E. Williams Center for Chiropractic Research
Marietta, Georgia, 30067
About this study
Official title: 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.
- Conditions
- Subluxation
- Being tested
- Adjustment, Sham
- Keywords
- Chiropractic, EEG, ECG, sham
- Medical subject headings
- Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdjustmentProcedure or surgery
Instrument-assisted, high velocity, low amplitude adjustment
ShamProcedure or surgery
Instrument-assisted light touch to neck
| Study group | Role | What they receive |
|---|---|---|
| Adjustment | Experimental | Individuals with a subluxation who receive a true chiropractic adjustment Receives: Procedure: Adjustment |
| Sham | Sham comparator | Individuals with a subluxation who receive a light touch-only sham Receives: Procedure: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG resting state effective connectivity
Baseline EEG recording for the first intervention or sham procedure. A 64-channel hydronet will be on the head to capture EEG.
Measured: 0 minutes
EEG resting state effective connectivity
EEG recording immediately after the first intervention or sham procedure. A 64-channel hydronet will be on the head to capture EEG.
Measured: 8 minutes
EEG resting state effective connectivity
Baseline EEG recording for the second intervention or sham procedure. A 64-channel hydronet will be on the head to capture EEG.
Measured: 15 minutes
EEG resting state effective connectivity
EEG recording immediately after the second intervention or sham procedure. A 64-channel hydronet will be on the head to capture EEG.
Measured: 23 minutes
Secondary outcomes (4)
ECG R-R interval
Baseline recording for the first intervention or sham procedure. Three leads will on the torso to capture a Lead II ECG.
Measured: 0 minutes
ECG R-R interval
ECG recording immediately after the first intervention or sham procedure. Three leads will on the torso to capture a Lead II ECG.
Measured: 8 minutes
ECG R-R interval
Baseline ECG recording for the second intervention or sham procedure. Three leads will on the torso to capture a Lead II ECG.
Measured: 15 minutes
ECG R-R interval
ECG recording immediately after the second intervention or sham procedure. Three leads will on the torso to capture a Lead II ECG.
Measured: 23 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start29 Jun 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion16 Dec 2025 (estimated)
Why it stopped: Reviewing protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SubluxationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, sham-controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Life University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Sullivan, DC, PhD, Study director, Life University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864703
- Sponsor's protocol ID
- I-0024
- Acronym
- INS
- Status last verified
- Aug 2024
- First submitted
- 9 May 2023
- Last updated
- 28 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Instantaneous Changes in EEG Activation Patterns Following Application of a Chiropractic Adjustment to the Cervical Spine
- ClinicalTrials.gov ID
- NCT05864703
- Acronym / sponsor ID
- INS / I-0024
- Conditions
- Subluxation
- Keywords
- Chiropractic, EEG, ECG, sham
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Reviewing protocol
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Life UniversityUniversity, hospital or other
- Study start
- 29 Jun 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 16 Dec 2025 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, sham-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Adjustment | Experimental | Procedure: AdjustmentIndividuals with a subluxation who receive a true chiropractic adjustment |
| Sham | Sham comparator | Procedure: ShamIndividuals with a subluxation who receive a light touch-only sham |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdjustmentInstrument-assisted, high velocity, low amplitude adjustment | Procedure or surgery | Adjustment |
| ShamInstrument-assisted light touch to neck | Procedure or surgery | Sham |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
ECG R-R interval
Time frame: 0 minutes
ECG R-R interval
Time frame: 8 minutes
ECG R-R interval
Time frame: 15 minutes
ECG R-R interval
Time frame: 23 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Sullivan, DC, PhD study director
Life University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjustment in people with Subluxation, run by Life University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG resting state effective connectivity (time frame: 0 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.