Post-concussion Syndrome and Chiropractic

Study Overview
=================
Brief Summary
-----------------
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.

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

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

Conditions
-----------------
Post-Concussion Syndrome

Intervention / Treatment
-----------------
* Procedure: Chiropractic adjustment


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: The intervention for this proof-of-concept trial is chiropractic manual adjustments. Participants will undergo chiropractic care from a state licensed chiropractor. Each individual's care plan will be determined by that individual and their specific field doctor for frequency of visits and type of chiropractic technique used. Participants will undergo 6 weeks of chiropractic for this study.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Length of time required to recruit target number of participants | through study completion, an average of 1 year | 
| Participant adherence rate | Proportion of participants able to adhere to the testing & treatment schedule | through study completion, an average of 1 year | 
| Participant tolerability rate | Proportion of participants able to perform all aspects of the testing regimen | through study completion, an average of 1 year | 
| Participant retention rate | Proportion of enrolled participants who complete the full testing regimen | through study completion, an average of 1 year | 
| Acceptability of treatment regimen for participants | 8-item Theoretical Framework of Acceptability questionnaire | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Composite Autonomic Symptom Score (COMPASS-31) | 31-item questionnaire | Day 0 | 
| Composite Autonomic Symptom Score (COMPASS-31) | 31-item questionnaire | Day 1 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chiropractic care, spinal manipulation, heart rate variability, autonomic nervous system, electroencephalography, interlimb symmetry, impedance cardiography, electrocardiography, electrodermal activity, chiropractic adjustment