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

NCT03997240 | Completed

• 1 other identifier: l-0012
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Shift Balance Platform

  10 minutes

Study Arms (2)

Wait-list control

OTHER

Six-week wait list control

Procedure: Chiropractic Applied Clinical Neuroscience

Immediate intervention

EXPERIMENTAL

Immediate treatment group

Procedure: Chiropractic Applied Clinical Neuroscience

Interventions

Chiropractic Applied Clinical Neuroscience PROCEDURE

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.

Immediate intervention; Wait-list control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Life University: lead

Study Sites (1)

NeuroLife Institute

Marietta, Georgia, 30060, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Stephanie Sullivan, DC, PhD

  Life University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 25, 2019
• Study Start: June 1, 2019
• Primary Completion: July 11, 2023
• Study Completion: July 11, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)