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Post-Concussion SyndromePCSNCT06151184

Post-concussion Syndrome and Chiropractic

A study testing Chiropractic adjustment in people with Post-Concussion Syndrome, run by Life University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post-Concussion Syndrome
What is being tested?
Chiropractic adjustment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
27 Jan 2024to 31 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 or older
  • Diagnosed by a physician with post-concussion syndrome 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
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  • 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 one month
  • Has not received any other interventions within the past one month such as osteopathic spinal manipulation, physical therapy rehabilitation or manipulation, massage, body movement therapies, or acupuncture

Who cannot join

  • 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
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  • 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)
  • Experiences daily/chronic pain >3 out of 10 on the visual analog scale (VAS)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Dr. Sid E. Williams Center for Chiropractic Research

    Marietta, Georgia, 30067

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested
Chiropractic adjustment
Keywords
chiropractic care, spinal manipulation, heart rate variability, autonomic nervous system, electroencephalography, interlimb symmetry, impedance cardiography, electrocardiography, electrodermal activity, chiropractic adjustment, chiropractic
Medical subject headings
Post-Concussion Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chiropractic adjustmentProcedure or surgery

    6 weeks of chiropractic care, with frequency and type of procedures determined by field clinician after initial examination.

Study groups in NCT06151184
Study groupRoleWhat they receive
Post-concussion syndrome participantsExperimentalPost-concussion syndrome participants will all receive manual chiropractic adjustment interventions.
Receives: Procedure: Chiropractic adjustment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participant recruitment

    Average number of participants recruited/enrolled per month

    Measured: 24 months (recruitment period)

  2. Participant scheduling

    Average time lag between first lab assessment \& first chiropractic visit

    Measured: 24 months (recruitment period)

  3. Participant compliance

    % of participants violating 1 or more pre-assessment lifestyle restrictions \& unable/unwilling to be rescheduled

    Measured: 24 months (recruitment period)

  4. Participant adherence

    % of participants not attending ≥80% of their chiropractic sessions

    Measured: 24 months (recruitment period)

  5. Participant tolerability

    % of participants unable/unwilling to complete a given assessment

    Measured: 24 months (recruitment period)

  6. Participant retention

    % of participants completing the trial

    Measured: 24 months (recruitment period)

  7. Assessment acceptability

    Most common participant-rated acceptability score for each assessment process/procedure

    Measured: 24 months (recruitment period)

  8. Intervention acceptability

    Most common participant-rated acceptability score for each aspect of the chiropractic care

    Measured: 24 months (recruitment period)

  9. Data fidelity

    % of acquisitions from a given assessment that are unsuitable for analysis

    Measured: 24 months (recruitment period)

  10. Implementation acceptability

    Most common clinician-rated acceptability score for each trial process/procedure

    Measured: 24 months (recruitment period)

Secondary outcomes (45)
  1. EEG resting state broadband power

    64-channel hydronet cap

    Measured: Day 1

  2. EEG resting state broadband power

    64-channel hydronet cap

    Measured: Week 2

  3. EEG resting state broadband power

    64-channel hydronet cap

    Measured: Week 6

  4. EEG resting state functional connectivity

    64-channel hydronet cap

    Measured: Day 1

  5. EEG resting state functional connectivity

    64-channel hydronet cap

    Measured: Week 2

  6. EEG resting state functional connectivity

    64-channel hydronet cap

    Measured: Week 6

  7. EEG evoked latency

    64-channel hydronet cap during auditory oddball task

    Measured: Day 1

  8. EEG evoked latency

    64-channel hydronet cap during auditory oddball task

    Measured: Week 2

  9. EEG evoked latency

    64-channel hydronet cap during auditory oddball task

    Measured: Week 6

  10. ECG mean interbeat interval

    3 sensors on torso

    Measured: Day 1

  11. ECG mean interbeat interval

    3 sensors on torso

    Measured: Week 2

  12. ECG mean interbeat interval

    3 sensors on torso

    Measured: Week 6

  13. ECG respiratory sinus arrhythmia (RSA)

    3 sensors on torso

    Measured: Day 1

  14. ECG respiratory sinus arrhythmia (RSA)

    3 sensors on torso

    Measured: Week 2

  15. ECG respiratory sinus arrhythmia (RSA)

    3 sensors on torso

    Measured: Week 6

  16. ECG de-trended fluctuation analysis

    3 sensors on torso

    Measured: Day 1

  17. ECG de-trended fluctuation analysis

    3 sensors on torso

    Measured: Week 2

  18. ECG de-trended fluctuation analysis

    3 sensors on torso

    Measured: Week 6

  19. Impedance cardiogram (ICG) pre-ejection period (PEP)

    2 sensors on chest and 2 sensors on back

    Measured: Day 1

  20. Impedance cardiogram (ICG) pre-ejection period (PEP)

    2 sensors on chest and 2 sensors on back

    Measured: Week 2

  21. Impedance cardiogram (ICG) pre-ejection period (PEP)

    2 sensors on chest and 2 sensors on back

    Measured: Week 6

  22. Impedance cardiogram (ICG) initial systolic time interval (ISTI)

    2 sensors on chest and 2 sensors on back

    Measured: Day 1

  23. Impedance cardiogram (ICG) initial systolic time interval (ISTI)

    2 sensors on chest and 2 sensors on back

    Measured: Week 2

  24. Impedance cardiogram (ICG) initial systolic time interval (ISTI)

    2 sensors on chest and 2 sensors on back

    Measured: Week 6

  25. Electrodermal activity (EDA) non-specific skin conductance responses (SCR)

    2 sensors on first and second digits of non-dominant hand

    Measured: Day 1

  26. Electrodermal activity (EDA) non-specific skin conductance responses (SCR)

    2 sensors on first and second digits of non-dominant hand

    Measured: Week 2

  27. Electrodermal activity (EDA) non-specific skin conductance responses (SCR)

    2 sensors on first and second digits of non-dominant hand

    Measured: Week 6

  28. Electrodermal activity (EDA) skin conductance level (SCL)

    2 sensors on first and second digits of non-dominant hand

    Measured: Day 1

  29. Electrodermal activity (EDA) skin conductance level (SCL)

    2 sensors on first and second digits of non-dominant hand

    Measured: Week 2

  30. Electrodermal activity (EDA) skin conductance level (SCL)

    2 sensors on first and second digits of non-dominant hand

    Measured: Week 6

  31. Composite Autonomic Symptom Score (COMPASS-31)

    31-item questionnaire

    Measured: Day 1

  32. Composite Autonomic Symptom Score (COMPASS-31)

    31-item questionnaire

    Measured: Week 2

  33. Composite Autonomic Symptom Score (COMPASS-31)

    31-item questionnaire

    Measured: Week 6

  34. Patient-Reported Outcomes Measurement Information System (PROMIS-29)

    29-item questionnaire

    Measured: Day 1

  35. Patient-Reported Outcomes Measurement Information System (PROMIS-29)

    29-item questionnaire

    Measured: Week 2

  36. Patient-Reported Outcomes Measurement Information System (PROMIS-29)

    29-item questionnaire

    Measured: Week 6

  37. Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8)

    8-item questionnaire

    Measured: Day 1

  38. Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8)

    8-item questionnaire

    Measured: Week 2

  39. Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8)

    8-item questionnaire

    Measured: Week 6

  40. Perceived Stress Scale (PSS)

    10-item questionnaire

    Measured: Day 1

  41. Perceived Stress Scale (PSS)

    10-item questionnaire

    Measured: Week 2

  42. Perceived Stress Scale (PSS)

    10-item questionnaire

    Measured: Week 6

  43. Post-Concussion Symptom Scale

    22-item questionnaire

    Measured: Day 1

  44. Post-Concussion Symptom Scale

    22-item questionnaire

    Measured: Week 2

  45. Post-Concussion Symptom Scale

    22-item questionnaire

    Measured: Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2023
  2. Study start27 Jan 2024
  3. Primary completion31 Jan 2026
  4. Study completion31 Jan 2026

Why it stopped: Resource constraints (i.e., lab budget cuts)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06151184
Sponsor's protocol ID
I-0025
Acronym
PCS
Status last verified
Mar 2026
First submitted
21 Nov 2023
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Chiropractic adjustment in people with Post-Concussion Syndrome, run by Life University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Resource constraints (i.e., lab budget cuts)). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant recruitment (time frame: 24 months (recruitment period)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.

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