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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
6 weeks of chiropractic care, with frequency and type of procedures determined by field clinician after initial examination.
Dr. Sid E. Williams Center for Chiropractic Research
Marietta, Georgia, United States
Participant recruitment
Average number of participants recruited/enrolled per month
Time frame: 24 months (recruitment period)
Participant scheduling
Average time lag between first lab assessment \& first chiropractic visit
Time frame: 24 months (recruitment period)
Participant compliance
% of participants violating 1 or more pre-assessment lifestyle restrictions \& unable/unwilling to be rescheduled
Time frame: 24 months (recruitment period)
Participant adherence
% of participants not attending ≥80% of their chiropractic sessions
Time frame: 24 months (recruitment period)
Participant tolerability
% of participants unable/unwilling to complete a given assessment
Time frame: 24 months (recruitment period)
Participant retention
% of participants completing the trial
Time frame: 24 months (recruitment period)
Assessment acceptability
Most common participant-rated acceptability score for each assessment process/procedure
Time frame: 24 months (recruitment period)
Intervention acceptability
Most common participant-rated acceptability score for each aspect of the chiropractic care
Time frame: 24 months (recruitment period)
Data fidelity
% of acquisitions from a given assessment that are unsuitable for analysis
Time frame: 24 months (recruitment period)
Implementation acceptability
Most common clinician-rated acceptability score for each trial process/procedure
Time frame: 24 months (recruitment period)
EEG resting state broadband power
64-channel hydronet cap
Time frame: Day 1
EEG resting state broadband power
64-channel hydronet cap
Time frame: Week 2
EEG resting state broadband power
64-channel hydronet cap
Time frame: Week 6
EEG resting state functional connectivity
64-channel hydronet cap
Time frame: Day 1
EEG resting state functional connectivity
64-channel hydronet cap
Time frame: Week 2
EEG resting state functional connectivity
64-channel hydronet cap
Time frame: Week 6
EEG evoked latency
64-channel hydronet cap during auditory oddball task
Time frame: Day 1
EEG evoked latency
64-channel hydronet cap during auditory oddball task
Time frame: Week 2
EEG evoked latency
64-channel hydronet cap during auditory oddball task
Time frame: Week 6
ECG mean interbeat interval
3 sensors on torso
Time frame: Day 1
ECG mean interbeat interval
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3 sensors on torso
Time frame: Week 2
ECG mean interbeat interval
3 sensors on torso
Time frame: Week 6
ECG respiratory sinus arrhythmia (RSA)
3 sensors on torso
Time frame: Day 1
ECG respiratory sinus arrhythmia (RSA)
3 sensors on torso
Time frame: Week 2
ECG respiratory sinus arrhythmia (RSA)
3 sensors on torso
Time frame: Week 6
ECG de-trended fluctuation analysis
3 sensors on torso
Time frame: Day 1
ECG de-trended fluctuation analysis
3 sensors on torso
Time frame: Week 2
ECG de-trended fluctuation analysis
3 sensors on torso
Time frame: Week 6
Impedance cardiogram (ICG) pre-ejection period (PEP)
2 sensors on chest and 2 sensors on back
Time frame: Day 1
Impedance cardiogram (ICG) pre-ejection period (PEP)
2 sensors on chest and 2 sensors on back
Time frame: Week 2
Impedance cardiogram (ICG) pre-ejection period (PEP)
2 sensors on chest and 2 sensors on back
Time frame: Week 6
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
2 sensors on chest and 2 sensors on back
Time frame: Day 1
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
2 sensors on chest and 2 sensors on back
Time frame: Week 2
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
2 sensors on chest and 2 sensors on back
Time frame: Week 6
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
2 sensors on first and second digits of non-dominant hand
Time frame: Day 1
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
2 sensors on first and second digits of non-dominant hand
Time frame: Week 2
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
2 sensors on first and second digits of non-dominant hand
Time frame: Week 6
Electrodermal activity (EDA) skin conductance level (SCL)
2 sensors on first and second digits of non-dominant hand
Time frame: Day 1
Electrodermal activity (EDA) skin conductance level (SCL)
2 sensors on first and second digits of non-dominant hand
Time frame: Week 2
Electrodermal activity (EDA) skin conductance level (SCL)
2 sensors on first and second digits of non-dominant hand
Time frame: Week 6
Composite Autonomic Symptom Score (COMPASS-31)
31-item questionnaire
Time frame: Day 1
Composite Autonomic Symptom Score (COMPASS-31)
31-item questionnaire
Time frame: Week 2
Composite Autonomic Symptom Score (COMPASS-31)
31-item questionnaire
Time frame: Week 6
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
29-item questionnaire
Time frame: Day 1
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
29-item questionnaire
Time frame: Week 2
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
29-item questionnaire
Time frame: Week 6
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8)
8-item questionnaire
Time frame: Day 1
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8)
8-item questionnaire
Time frame: Week 2
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8)
8-item questionnaire
Time frame: Week 6
Perceived Stress Scale (PSS)
10-item questionnaire
Time frame: Day 1
Perceived Stress Scale (PSS)
10-item questionnaire
Time frame: Week 2
Perceived Stress Scale (PSS)
10-item questionnaire
Time frame: Week 6
Post-Concussion Symptom Scale
22-item questionnaire
Time frame: Day 1
Post-Concussion Symptom Scale
22-item questionnaire
Time frame: Week 2
Post-Concussion Symptom Scale
22-item questionnaire
Time frame: Week 6