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

Not Applicable

Completed

• Conditions: Depression
• Interventions: Procedure: Chiropractic Applied Clinical Neuroscience

• Registration Number: NCT03997240
• Lead Sponsor: Life University

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:

1. Does a multimodal chiropractic applied clinical neuroscience approach to care affect self-reported symptoms of depression?

2. Does a multimodal chiropractic applied clinical neuroscience approach to care affect dysmetria and balance control in a clinically depressed population?

3. Are changes in dysmetria and balance control correlated with a change in depressive symptoms.

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2019-06-24
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-25
• Primary Completion: 2023-07-11
• Study Completion: 2023-07-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Wait-list control	Chiropractic Applied Clinical Neuroscience	Six-week wait list control
Immediate intervention	Chiropractic Applied Clinical Neuroscience	Immediate treatment group

Primary Outcome Measures

Name	Time	Method
P300 Auditory Evoked Potential task	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.

Secondary Outcome Measures

Name	Time	Method
Shift Balance Platform	10 minutes	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.

Trial Locations

Locations (1)

NeuroLife Institute; 🇺🇸 Marietta, Georgia, United States