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

Depression Clinical Trial

— DEP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03997240
• Other study ID #: l-0012
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: July 11, 2023

Study information

• Verified date: February 2024
• Source: Life University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pilot study design that operationalizes the multimodal manner of care while evaluating changes in depression symptoms, dysmetria, and balance for medication non-responders.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 11, 2023
• Est. primary completion date: July 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	NeuroLife Institute	Marietta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Life University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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