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

• Sponsor: Life University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03997240
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 42
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Procedure: Chiropractic Applied Clinical Neuroscience	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 1, 2019
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Wait-list control Six-week wait list control	Procedure: Chiropractic Applied Clinical Neuroscience; 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.
Experimental: Immediate intervention Immediate treatment group	Procedure: Chiropractic Applied Clinical Neuroscience; 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NeuroLife Institute	Marietta	Georgia	United States	30060

Sponsors and Collaborators

• Life University

Investigators

• Principal Investigator: Stephanie Sullivan, Life University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stephanie Sullivan, DC, Director, Dr. Sid E. Williams Center for Chiropractic Research, Life University
• ClinicalTrials.gov Identifier: NCT03997240
• Other Study ID Numbers: l-0012
• First Posted: Jun 25, 2019
• Last Update Posted: Jan 19, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

No Results Posted as of Jan 19, 2022