Back to resultsApplied Clinical Neuroscience Care for Self-reported Symptoms of Depression and Cerebellar Function in Adults
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chiropractic Applied Clinical Neuroscience
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria:
- Over the age of 18
- Medically diagnosed with depression
- Score at least a 10 on the Depression Anxiety and Stress Scale (DASS)
- Must be taking anti-depressant medication with a minimum three-month history of medication use
- Must be experiencing limited or no relief of symptoms from the medication
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
Sites / Locations
- NeuroLife Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Wait-list control
Immediate intervention
Arm Description
Six-week wait list control
Immediate treatment group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03997240
Brief Title
Applied Clinical Neuroscience Care for Self-reported Symptoms of Depression and Cerebellar Function in Adults
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
July 11, 2023 (Actual)
Study Completion Date
July 11, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Life University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wait-list control
Arm Type
Other
Arm Description
Six-week wait list control
Arm Title
Immediate intervention
Arm Type
Experimental
Arm Description
Immediate treatment group
Intervention Type
Procedure
Intervention Name(s)
Chiropractic Applied Clinical Neuroscience
Intervention Description
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.
Primary Outcome Measure Information:
Title
P300 Auditory Evoked Potential task
Description
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.
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Shift Balance Platform
Description
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.
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Sullivan, DC, PhD
Organizational Affiliation
Life University
Official's Role
Principal Investigator
Facility Information:
Facility Name
NeuroLife Institute
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Applied Clinical Neuroscience Care for Self-reported Symptoms of Depression and Cerebellar Function in Adults
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