Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06151184
Status:
RECRUITING
Last Update Posted:
2024-01-17
First Post:
2023-11-21
Brief Title:
Post-concussion Syndrome and Chiropractic
Sponsor:
Life University
Organization:
Life University
Study Overview
Official Title:
The Effects of Chiropractic Manual Adjustments on Nervous System Function in Individuals With Post-concussion Syndrome a Proof of Concept Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PCS
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
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 25 - 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None