Post-concussion Syndrome and Chiropractic (PCS)

The Effects of Chiropractic Manual Adjustments on Nervous System Function in Individuals With Post-concussion Syndrome: a Proof of Concept Trial

This proof-of-concept trial will explore the effects of manual chiropractic adjustments on nervous system function in individuals with post-concussion syndrome. This study will aim to recruit 10 individuals to receive 6 weeks of chiropractic care with 3 assessment periods. The participants will undergo a baseline assessment, mid-trial assessment, and post-trial assessment. The participants will wear an electroencephalography (EEG) cap for a neural assessment during an event related potential. They will wear electrical diodes to measure electrocardiography (ECG), impedance cardiography (ICG), and electrodermal activity (EDA) throughout the study and during an orthostatic challenge. Additional sensors will be placed on the participant to measure interlimb symmetry patterns during gait while walking on a treadmill.

Study Overview

• Status: Recruiting
• Conditions: Post-Concussion Syndrome
• Intervention / Treatment: Procedure: Chiropractic adjustment

Detailed Description

Participants enrolled in the study will take a screening questionnaire to first determine eligibility. Once qualified, each individual will undergo a physical exam by a state licensed chiropractor to determine if there are any contraindications to undergo chiropractic care throughout the duration of the study. Each participant will receive 6 weeks of chiropractic care and will be assessed at weeks 0, 2, and 6 at the Dr. Sid E Williams Center for Chiropractic Research. Each participant will perform a number of tests to determine the evaluated function of their nervous system. In total, 3 different tests will be performed by the participant during an assessment visit that will take approximately 2.5 - 3 hours. During the assessments, each individual will be wearing electrical diodes to continually monitor ECG, ICG, and EDA. The specific assessments will be as follows:

1. Wearing an EEG net and then perform an event related potential after a baseline recording
2. Performing an orthostatic challenge while measuring ECG, ICG, and EDA
3. Wearing motion sensors while walking at a comfortable pace on a treadmill to evaluate interlimb symmetry and gait dynamics

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Austin Garlinghouse; Phone Number: 7704262639; Email: research.studies@life.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Recruiting
      • Dr. Sid E. Williams Center for Chiropractic Research
      • Contact: Austin Garlinghouse; Phone Number: 770-426-2639; Email: research.studies@life.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 or older
• Diagnosed by a physician with PCS OR self-identifies as having a concussion based on responses to the HELPS screening tool
• Has at least 3 of the following chronic symptoms at least 3 months since concussion: headache; dizziness; insomnia; fatigue; concentration difficulty; memory difficulty; intolerance to stress, emotions, and alcohol; irritability
• Able to understand and communicate in English
• Able to make informed decisions without assistance
• Can wear an EEG net for 40 minutes
• Can sit quietly for at least 15 minutes
• Capable of walking on a treadmill at a comfortable pace for 10 minutes consecutively
• Capable of moving from a supine to standing to supine position quickly and safely
• Able to wear multiple electrodes placed on chest, back, and fingertips
• Able to wear multiple sensors placed on head, back, pelvis, hands, arms, and legs
• Has not had a chiropractic adjustment within the last three months
• Has not received any other interventions within the past three months such as osteopathic spinal manipulation, physical therapy rehabilitation or manipulation, massage, body movement therapies, or acupuncture
• Able to provide the name and contact of a medical care provider (i.e., primary physician, therapist, or neurologist) they have received care from recently or in the past

Exclusion Criteria:

• Diagnosed with a serious mental disorder such as schizophrenia or bipolar disorder
• Has malignant hypertension, which is a condition whereby their blood pressure rises suddenly and quickly
• Has a known condition that causes syncope with postural changes, such as POTS
• Has an implanted device (i.e., pacemaker)
• Has a physical disability affecting their gait
• Has a history of previous surgery or injury to the musculoskeletal structures or skull in the past three months
• Has a prosthetic for any extremity
• Has a hearing impairment or uses a hearing aid
• History of stroke
• Taking short-acting benzodiazepines, which includes midazolam and triazolam
• Involved with current litigation related to a physical health-related injury
• Untreated diagnosed osteoporosis or articular instability such as atlanto-axial instability
• Currently pregnant
• Unwilling to wash hair/head and remove hair products, accessories, braids, or wigs for assessment appointments
• Deemed high-risk using the Columbia-Suicide Severity Rating Scale (C-SSRS) and referred for further evaluation (assessed at initial session in lab)
• Pain on the day of testing rated higher than 3/10 on a visual analog scale (VAS)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Post-concussion syndrome participants; Post-concussion syndrome participants will all receive manual chiropractic adjustment interventions.	Procedure: Chiropractic adjustment; 6 weeks of chiropractic care, with frequency and type of procedures determined by field clinician after initial examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant recruitment	Average number of participants recruited/enrolled per month	6 months (recruitment period)
Participant scheduling	Average time lag between first lab assessment & first chiropractic visit	6 months (recruitment period)
Participant compliance	% of participants violating 1 or more pre-assessment lifestyle restrictions & unable/unwilling to be rescheduled	6 months (recruitment period)
Participant adherence	% of participants not attending ≥80% of their chiropractic sessions	6 months (recruitment period)
Participant tolerability	% of participants unable/unwilling to complete a given assessment	6 months (recruitment period)
Participant retention	% of participants completing the trial	6 months (recruitment period)
Assessment acceptability	Most common participant-rated acceptability score for each assessment process/procedure	6 months (recruitment period)
Intervention acceptability	Most common participant-rated acceptability score for each aspect of the chiropractic care	6 months (recruitment period)
Data fidelity	% of acquisitions from a given assessment that are unsuitable for analysis	6 months (recruitment period)
Implementation acceptability	Most common clinician-rated acceptability score for each trial process/procedure	6 months (recruitment period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrodermal activity (EDA) skin conductance level (SCL)	2 sensors on first and second digits of non-dominant hand	Day 1
Electrodermal activity (EDA) skin conductance level (SCL)	2 sensors on first and second digits of non-dominant hand	Week 2
Electrodermal activity (EDA) skin conductance level (SCL)	2 sensors on first and second digits of non-dominant hand	Week 6
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)	2 sensors on first and second digits of non-dominant hand	Day 1
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)	2 sensors on first and second digits of non-dominant hand	Week 2
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)	2 sensors on first and second digits of non-dominant hand	Week 6
Impedance cardiogram (ICG) pre-ejection period (PEP)	2 sensors on chest and 2 sensors on back	Day 1
Impedance cardiogram (ICG) pre-ejection period (PEP)	2 sensors on chest and 2 sensors on back	Week 2
Impedance cardiogram (ICG) pre-ejection period (PEP)	2 sensors on chest and 2 sensors on back	Week 6
Impedance cardiogram (ICG) initial systolic time interval (ISTI)	2 sensors on chest and 2 sensors on back	Day 1
Impedance cardiogram (ICG) initial systolic time interval (ISTI)	2 sensors on chest and 2 sensors on back	Week 2
Impedance cardiogram (ICG) initial systolic time interval (ISTI)	2 sensors on chest and 2 sensors on back	Week 6
ECG respiratory sinus arrhythmia (RSA)	3 sensors on torso	Day 1
ECG respiratory sinus arrhythmia (RSA)	3 sensors on torso	Week 2
ECG respiratory sinus arrhythmia (RSA)	3 sensors on torso	Week 6
ECG de-trended fluctuation analysis	3 sensors on torso	Day 1
ECG de-trended fluctuation analysis	3 sensors on torso	Week 2
ECG de-trended fluctuation analysis	3 sensors on torso	Week 6
EEG resting state broadband power	64-channel hydronet cap	Day 1
EEG resting state broadband power	64-channel hydronet cap	Week 2
EEG resting state broadband power	64-channel hydronet cap	Week 6
EEG resting state functional connectivity	64-channel hydronet cap	Day 1
EEG resting state functional connectivity	64-channel hydronet cap	Week 2
EEG resting state functional connectivity	64-channel hydronet cap	Week 6
EEG evoked latency	64-channel hydronet cap during auditory oddball task	Day 1
EEG evoked latency	64-channel hydronet cap during auditory oddball task	Week 2
EEG evoked latency	64-channel hydronet cap during auditory oddball task	Week 6
ECG mean interbeat interval	3 sensors on torso	Day 1
ECG mean interbeat interval	3 sensors on torso	Week 2
ECG mean interbeat interval	3 sensors on torso	Week 6
Composite Autonomic Symptom Score (COMPASS-31)	31-item questionnaire	Day 0
Composite Autonomic Symptom Score (COMPASS-31)	31-item questionnaire	Week 2
Composite Autonomic Symptom Score (COMPASS-31)	31-item questionnaire	Week 6
Patient-Reported Outcomes Measurement Information System (PROMIS-29)	29-item questionnaire	Day 0
Patient-Reported Outcomes Measurement Information System (PROMIS-29)	29-item questionnaire	Day 1
Patient-Reported Outcomes Measurement Information System (PROMIS-29)	29-item questionnaire	Week 2
Patient-Reported Outcomes Measurement Information System (PROMIS-29)	29-item questionnaire	Week 6
Perceived Stress Scale (PSS)	10-item questionnaire	Day 0
Perceived Stress Scale (PSS)	10-item questionnaire	Day 1
Perceived Stress Scale (PSS)	10-item questionnaire	Week 2
Perceived Stress Scale (PSS)	10-item questionnaire	Week 6
Composite Autonomic Symptom Score (COMPASS-31)	31-item questionnaire	Day 1
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8)	8-item questionnaire	Day 0
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8)	8-item questionnaire	Day 1
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8)	8-item questionnaire	Week 2
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8)	8-item questionnaire	Week 6
Post-Concussion Symptom Scale	22-item questionnaire	Day 0
Post-Concussion Symptom Scale	22-item questionnaire	Day 1
Post-Concussion Symptom Scale	22-item questionnaire	Week 2
Post-Concussion Symptom Scale	22-item questionnaire	Week 6

Collaborators and Investigators

• Sponsor: Life University
• Investigators: Principal Investigator: Daimeyon Williams, Life University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): July 15, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: spinal manipulation; autonomic nervous system; heart rate variability; electroencephalography; impedance cardiography; chiropractic; electrocardiography; electrodermal activity; chiropractic care; interlimb symmetry; chiropractic adjustment
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Craniocerebral Trauma; Trauma, Nervous System; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating; Syndrome; Post-Concussion Syndrome
• Other Study ID Numbers: I-0025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No