Post-concussion Syndrome and Chiropractic

NCT06151184 | Terminated

• 1 other identifier: I-0025
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Concussion Syndrome

Keywords

chiropractic care; spinal manipulation; heart rate variability; autonomic nervous system; electroencephalography; interlimb symmetry; impedance cardiography; electrocardiography; electrodermal activity; chiropractic adjustment; chiropractic

Outcome Measures

Primary Outcomes (10)

• Participant recruitment

  Average number of participants recruited/enrolled per month

  24 months (recruitment period)

• Participant scheduling

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

  24 months (recruitment period)

• Participant compliance

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

  24 months (recruitment period)

• Participant adherence

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

  24 months (recruitment period)

• Participant tolerability

  % of participants unable/unwilling to complete a given assessment

  24 months (recruitment period)

• Participant retention

  % of participants completing the trial

  24 months (recruitment period)

• Assessment acceptability

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

  24 months (recruitment period)

• Intervention acceptability

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

  24 months (recruitment period)

• Data fidelity

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

  24 months (recruitment period)

• Implementation acceptability

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

  24 months (recruitment period)

Secondary Outcomes (45)

• EEG resting state broadband power

  Day 1

• EEG resting state broadband power

  Week 2

• EEG resting state broadband power

  Week 6

• EEG resting state functional connectivity

  Day 1

• EEG resting state functional connectivity

  Week 2

Study Arms (1)

Post-concussion syndrome participants

EXPERIMENTAL

Post-concussion syndrome participants will all receive manual chiropractic adjustment interventions.

Procedure: Chiropractic adjustment

Interventions

Chiropractic adjustment PROCEDURE

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

Post-concussion syndrome participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Life University: lead

Study Sites (1)

Dr. Sid E. Williams Center for Chiropractic Research

Marietta, Georgia, 30067, United States

Location

MeSH Terms

Conditions

Post-Concussion Syndrome

Interventions

Manipulation, Chiropractic

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics

Study Officials

• Ahmed Qazi

  Life University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 30, 2023
• Study Start: January 27, 2024
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)