RECRUITING

Post-concussion Syndrome and Chiropractic

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-27
Study Completion:2025-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06151184

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 or older
  2. * Diagnosed by a physician with PCS OR self-identifies as having a concussion based on responses to the HELPS screening tool
  3. * 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
  4. * Able to understand and communicate in English
  5. * Able to make informed decisions without assistance
  6. * Can wear an EEG net for 40 minutes
  7. * Can sit quietly for at least 15 minutes
  8. * Capable of walking on a treadmill at a comfortable pace for 10 minutes consecutively
  9. * Capable of moving from a supine to standing to supine position quickly and safely
  10. * Able to wear multiple electrodes placed on chest, back, and fingertips
  11. * Able to wear multiple sensors placed on head, back, pelvis, hands, arms, and legs
  12. * Has not had a chiropractic adjustment within the last one months
  13. * 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
  1. * Diagnosed with a serious mental disorder such as schizophrenia or bipolar disorder
  2. * Has malignant hypertension, which is a condition whereby their blood pressure rises suddenly and quickly
  3. * Has a known condition that causes syncope with postural changes, such as POTS
  4. * Has an implanted device (i.e., pacemaker)
  5. * Has a physical disability affecting their gait
  6. * Has a history of previous surgery or injury to the musculoskeletal structures or skull in the past three months
  7. * Has a prosthetic for any extremity
  8. * Has a hearing impairment or uses a hearing aid
  9. * History of stroke
  10. * Taking short-acting benzodiazepines, which includes midazolam and triazolam
  11. * Involved with current litigation related to a physical health-related injury
  12. * Untreated diagnosed osteoporosis or articular instability such as atlanto-axial instability
  13. * Currently pregnant
  14. * Unwilling to wash hair/head and remove hair products, accessories, braids, or wigs for assessment appointments
  15. * Deemed high-risk using the Columbia-Suicide Severity Rating Scale (C-SSRS) and referred for further evaluation (assessed at initial session in lab)
  16. * Experiences daily/chronic pain \>3 out of 10 on the visual analog scale (VAS)

Contacts and Locations

Study Contact

Daekiara Smith-Ireland, MPH
CONTACT
7704262639
research.studies@life.edu

Principal Investigator

Daimeyon Williams
PRINCIPAL_INVESTIGATOR
Life University

Study Locations (Sites)

Dr. Sid E. Williams Center for Chiropractic Research
Marietta, Georgia, 30067
United States

Collaborators and Investigators

Sponsor: Life University

  • Daimeyon Williams, PRINCIPAL_INVESTIGATOR, Life University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-27
Study Completion Date2025-01-31

Study Record Updates

Study Start Date2024-01-27
Study Completion Date2025-01-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Post-Concussion Syndrome