DepressionDEPNCT03997240
Applied Clinical Neuroscience Care for Self-reported Symptoms of Depression and Cerebellar Function in Adults
A study testing Chiropractic Applied Clinical Neuroscience in people with Depression, run by Life University at 1 site in United States.
Trial summary
Pilot study design that operationalizes the multimodal manner of care while evaluating changes in depression symptoms, dysmetria, and balance for medication non-responders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Chiropractic Applied Clinical Neuroscience
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 11 Jul 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You are over the age of 18.
- You have been diagnosed with depression.
- You are currently taking medication for depression or have previously taken medication.
- You have been or were on your depression medication for at least 3 months.
- You feel/felt that the medication is/was not helping.
Who cannot join
- Had a lifetime history of severe neurologic or mental illness (e.g. schizophrenia or substance abuse)
- Are pregnant
- Have pending litigation or a recent history of spinal fracture, metastatic cancer, chiropractic care within the past month
- Present with contraindications to chiropractic care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Wait-list Control Trial Evaluating the Effect of Team-based Applied Clinical Neuroscience Care on Self-reported Symptoms of Depression and Cerebellar Function in Adults With Medication-resistant Depression
Pilot study design that operationalizes the multimodal manner of care while evaluating changes in depression symptoms, dysmetria, and balance for medication non-responders.
Read the detailed description
Pilot study design that operationalizes the multimodal manner of care while evaluating changes in depression symptoms, dysmetria, and balance for medication non-responders. This research will provide an initial first step towards answering the following three research questions:
- Does a multimodal chiropractic applied clinical neuroscience approach to care affect self-reported symptoms of depression?
- Does a multimodal chiropractic applied clinical neuroscience approach to care affect dysmetria and balance control in a clinically depressed population?
- Are changes in dysmetria and balance control correlated with a change in depressive symptoms.
- Conditions
- Depression
- Being tested
- Chiropractic Applied Clinical Neuroscience
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic Applied Clinical NeuroscienceProcedure or surgery
Chiropractic Applied Clinical Neuroscience makes use of chiropractic care in addition to application of therapies designed to stimulate multisensory reintegration and cerebellar coordination. The multisensory reintegration and cerebellar therapies make use of the body's own sensory receptors as a target, with the purpose of realigning the brain's interpretation of different afferent signals. Observation of motor and autonomic output patterns during and after sensory stimulation afford the clinician real-time feedback, providing for adaptation of the sensory based protocol.
| Study group | Role | What they receive |
|---|---|---|
| Wait-list control | Other | Six-week wait list control Receives: Procedure: Chiropractic Applied Clinical Neuroscience |
| Immediate intervention | Experimental | Immediate treatment group Receives: Procedure: Chiropractic Applied Clinical Neuroscience |
What is being measured
The primary outcome is the main question the study is designed to answer.
P300 Auditory Evoked Potential task
Time-locked electroencephalography recording of the P300 event related potential. P300 testing involves placing electrodes on the participant's scalp while the individual is listening to a series to two different tones through headphones.
Measured: 20 minutes
Secondary outcomes (1)
Shift Balance Platform
Limits of stability test: For the limits of stability test the participant will be asked to lean forward, backward, left, and right. The participant will lean slowly in each direction at a self-determined speed and to a point where he or she feels is the maximum leaning distance without falling. The tests should take about 2 minutes but will vary based on the participant.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start1 Jun 2019
- Primary completion11 Jul 2023
- Study completion11 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Life University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Sullivan, DC, PhD, Principal investigator, Life University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997240
- Sponsor's protocol ID
- l-0012
- Acronym
- DEP
- Status last verified
- Feb 2024
- First submitted
- 24 Jun 2019
- Last updated
- 2 Feb 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 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Wait-list Control Trial Evaluating the Effect of Team-based Applied Clinical Neuroscience Care on Self-reported Symptoms of Depression and Cerebellar Function in Adults With Medication-resistant Depression
- ClinicalTrials.gov ID
- NCT03997240
- Acronym / sponsor ID
- DEP / l-0012
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Life UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 11 Jul 2023 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 25 Jun 2019 (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.
Pilot study design that operationalizes the multimodal manner of care while evaluating changes in depression symptoms, dysmetria, and balance for medication non-responders.
Detailed description
Pilot study design that operationalizes the multimodal manner of care while evaluating changes in depression symptoms, dysmetria, and balance for medication non-responders. This research will provide an initial first step towards answering the following three research questions:
- Does a multimodal chiropractic applied clinical neuroscience approach to care affect self-reported symptoms of depression?
- Does a multimodal chiropractic applied clinical neuroscience approach to care affect dysmetria and balance control in a clinically depressed population?
- Are changes in dysmetria and balance control correlated with a change in depressive symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait-list control | Other | Procedure: Chiropractic Applied Clinical NeuroscienceSix-week wait list control |
| Immediate intervention | Experimental | Procedure: Chiropractic Applied Clinical NeuroscienceImmediate treatment group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- You are over the age of 18.
- You have been diagnosed with depression.
- You are currently taking medication for depression or have previously taken medication.
- You have been or were on your depression medication for at least 3 months.
- You feel/felt that the medication is/was not helping.
Key exclusion criteria (4 listed)
- Had a lifetime history of severe neurologic or mental illness (e.g. schizophrenia or substance abuse)
- Are pregnant
- Have pending litigation or a recent history of spinal fracture, metastatic cancer, chiropractic care within the past month
- Present with contraindications to chiropractic care
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 Applied Clinical NeuroscienceChiropractic Applied Clinical Neuroscience makes use of chiropractic care in addition to application of therapies designed to stimulate multisensory reintegration and cerebellar coordination. The multisensory reintegration and cerebellar therapies make use of the body's own sensory receptors as a target, with the purpose of realigning the brain's interpretation of different afferent signals. Observation of motor and autonomic output patterns during and after sensory stimulation afford the clinician real-time feedback, providing for adaptation of the sensory based protocol. | Procedure or surgery | Immediate intervention, Wait-list control |
Primary outcome
P300 Auditory Evoked Potential task
Time frame: 20 minutes
Time-locked electroencephalography recording of the P300 event related potential. P300 testing involves placing electrodes on the participant's scalp while the individual is listening to a series to two different tones through headphones.
1 secondary outcome
Shift Balance Platform
Time frame: 10 minutes
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 2 Feb 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 principal investigator
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 Chiropractic Applied Clinical Neuroscience in people with Depression, 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 4 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 2 Feb 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. 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?
P300 Auditory Evoked Potential task (time frame: 20 minutes). 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 2 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.