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Procedure

Chiropractic Adjustment for Post-Concussion Syndrome (PCS Trial)

N/A
Recruiting
Led By Daimeyon Williams
Research Sponsored by Life University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to make informed decisions without assistance
18 or older
Must not have
Has a known condition that causes syncope with postural changes, such as POTS
Untreated diagnosed osteoporosis or articular instability such as atlanto-axial instability
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months (recruitment period)
Awards & highlights

Summary

This trial will explore the effects of chiropractic care on the nervous system in people with post-concussion syndrome. Participants will wear sensors to measure heart rate, sweat, brain waves, & more.

Who is the study for?
Adults diagnosed with post-concussion syndrome (PCS) or those who believe they've had a concussion, experiencing symptoms like headaches and memory issues for at least 3 months. Participants must be able to wear sensors, walk on a treadmill, and have not received chiropractic adjustments or similar treatments in the last three months. Exclusions include serious mental disorders, certain physical conditions affecting blood pressure or gait, hearing impairments, recent surgeries, pregnancy, and high suicide risk.
What is being tested?
The trial is testing if manual chiropractic adjustments can improve nervous system function in people with PCS. It involves 10 participants receiving chiropractic care over six weeks with assessments using EEG for brain activity and other sensors to monitor heart rate variability and movement patterns during different activities.
What are the potential side effects?
Chiropractic adjustments may cause temporary discomfort or soreness at the adjustment site. Rarely there might be headaches or fatigue following treatment sessions. Serious side effects are uncommon but could include nerve damage or worsening of existing spinal injuries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can make my own healthcare decisions.
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I am 18 years old or older.
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I can wear electrodes on my chest, back, and fingertips.
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I can walk on a treadmill for 10 minutes without stopping.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition that causes fainting when I stand up.
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I have untreated osteoporosis or unstable joints.
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I have a physical disability that affects how I walk.
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I have a condition where my blood pressure suddenly spikes very high.
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I am currently taking short-acting anxiety or sleep medication.
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I have had a stroke in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months (recruitment period)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months (recruitment period) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment acceptability
Data fidelity
Implementation acceptability
+7 more
Secondary study objectives
Composite Autonomic Symptom Score (COMPASS-31)
ECG de-trended fluctuation analysis
ECG mean interbeat interval
+12 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Post-concussion syndrome participantsExperimental Treatment1 Intervention
Post-concussion syndrome participants will all receive manual chiropractic adjustment interventions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chiropractic adjustment
2013
N/A
~80

Find a Location

Who is running the clinical trial?

Life UniversityLead Sponsor
19 Previous Clinical Trials
409 Total Patients Enrolled
Daimeyon WilliamsPrincipal InvestigatorLife University
~1 spots leftby Nov 2024
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