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

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ClinicalTrials.gov Identifier: NCT03997240
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Stephanie Sullivan, DC, 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. 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.

Condition or disease Intervention/treatment Phase
Depression Procedure: Chiropractic Applied Clinical Neuroscience Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chiropractic

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Shift Balance Platform [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997240


Contacts
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Contact: Stephanie Sullivan, DC, PhD 770-426-2636 stephanie.sullivan@life.edu

Locations
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United States, Georgia
NeuroLife Institute Recruiting
Marietta, Georgia, United States, 30060
Contact: Ruby Jordan    770-426-2829    ruby.jordan@life.edu   
Sponsors and Collaborators
Life University
Investigators
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Principal Investigator: Stephanie Sullivan Life University

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Responsible Party: Stephanie Sullivan, DC, Director, Dr. Sid E. Williams Center for Chiropractic Research, Life University
ClinicalTrials.gov Identifier: NCT03997240     History of Changes
Other Study ID Numbers: l-0012
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders