Brain FunctionNCT01953614
Effects of Chiropractic Adjustments on Brain Function Using Quantitative Encephalography
A study testing Chiropractic adjustment in people with Brain Function, run by Life University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Function
- What is being tested?
- Chiropractic adjustment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Dec 2015
- 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 10 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Must be able to receive chiropractic adjustments
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Brain Function
- Being tested
- Chiropractic adjustment, Sham adjustment
- Keywords
- quantitative encephalography, brain computer interface, chiropractic, sacro-occipital technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic adjustmentOther
Sham adjustmentOther
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Sham comparator | 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. Receives: Other: Sham adjustment |
| Chiropractic adjustment | Active comparator | Ten people. Group will be getting chiropractic adjustments. Participants will be filling out Achenbach questionnaire. There will be a follow up in 7 days. Receives: Other: Chiropractic adjustment |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, during adjustment, after adjustment, follow up in 7 days
Secondary outcomes (1)
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.
Measured: At baseline, one week after adjustment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain FunctionStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Life University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953614
- Sponsor's protocol ID
- I-0010
- Status last verified
- Apr 2016
- First submitted
- 23 Aug 2013
- Last updated
- 20 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chiropractic Adjustments on Brain Function Using Quantitative Encephalography
- ClinicalTrials.gov ID
- NCT01953614
- Acronym / sponsor ID
- I-0010
- Conditions
- Brain Function
- Keywords
- quantitative encephalography, brain computer interface, chiropractic, sacro-occipital technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Life UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Oct 2013 (estimated)
- 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Sham comparator | Other: Sham adjustmentTen 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. |
| Chiropractic adjustment | Active comparator | Other: Chiropractic adjustmentTen people. Group will be getting chiropractic adjustments. Participants will be filling out Achenbach questionnaire. There will be a follow up in 7 days. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 10 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Must be able to receive chiropractic adjustments
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Chiropractic adjustment | Other | Chiropractic adjustment |
| Sham adjustment | Other | Placebo group |
Primary outcome
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.
1 secondary outcome
Behavioral assessment questionaire
Time frame: At baseline, one week after adjustment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic adjustment in people with Brain Function, 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 20 Apr 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in quantitative EEG values as compared to a normative database (time frame: Baseline, during adjustment, after adjustment, follow up in 7 days). 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 20 Apr 2016.