Applied Clinical Neuroscience Care for Self-reported Symptoms of Depression and Cerebellar Function in Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Depression

Intervention / Treatment
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* Procedure: Chiropractic Applied Clinical Neuroscience


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Wait-list control<br>Six-week wait list control | Procedure: Chiropractic Applied Clinical Neuroscience<br>* 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.<br>|
| Experimental: Immediate intervention<br>Immediate treatment group | Procedure: Chiropractic Applied Clinical Neuroscience<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 10 minutes |