Clinical trial NCT05884437: The Effects of Chiropractic in Adults With Metabolic Syndrome
Official title: The Effects of Chiropractic Care on the Brain, Autonomic Nervous System, Gait, and Patient Reported Outcomes in Adults With Diagnosed or Suspected Metabolic Syndrome: a Proof-of-concept Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Chiropractic
Metabolic syndrome
Spinal manipulation
autonomic nervous system
EEG
patient reported outcomes
Lead sponsor: Life University
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm pilot
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the feasibility of our study procedures/protocols and to look at the potential effects of chiropractic care on people with metabolic syndrome.

Detailed description: After providing informed consent, individuals will undergo 6 weeks of chiropractic care. Throughout these 6 weeks there will be three assessments (Day 0, Week 2, and Week 6) that each include the following:

1. Seated resting recording
2. Auditory oddball task
3. Isometric hand grip
4. Postural challenge
5. Treadmill walking
6. Patient-reported outcome surveys

Each assessment will consist of the following recordings:

1. Electroencephalography \[EEG\]
2. Electrodermal activity \[EDA\]
3. Impedance cardiography \[ICG\]
4. Electrocardiogram \[ECG\]

Eligibility criteria: Inclusion Criteria:

* Individuals over the age of 18
* Individuals who can wear an EEG net for 30 minutes
* Individuals who can sit quietly for at least 15 minutes
* Individuals who can walk unassisted for up to 10 minutes
* Individuals who can provide informed consent
* Individuals who meet 3 of the 5 following criteria:

  * Elevated waist circumference (\>40 in/102 cm if male and \>35 in/88cm if female)
  * Elevated triglycerides (\>150 mg/dL) or drug treatment for elevated triglycerides
  * Reduced HDL-cholesterol (\<40mg/dL if male and \<50 mg/dL if female) or drug treatment to increase HDL-C
  * Elevated blood pressure (\>130 mm Hg systolic BP or \>85 mm Hg diastolic BP) or drug treatment to reduce blood pressure
  * Elevated fasting glucose (\>100 mg/dL) or drug treatment to reduce blood glucose

Exclusion Criteria:

* Individuals with a known disorder resulting in syncope/fainting during postural changes (e.g., POTS, orthostatic hypotension)
* Individuals with impaired function of the dominant hand
* Individuals with malignant hypertension
* Individuals with a known heart condition such as arrhythmia that results in an aberrant ECG recording
* Individuals with any implanted devices (i.e., pacemakers)
* Individuals with brain aneurysms
* Individuals with a history of epilepsy or stroke that would influence EEG readings
* Individuals with a diagnosed externalizing or thought disorder (i.e., anti-social disorder, any major personality disorder such as borderline personality disorder, or schizophrenia)
* Individuals who are on short-acting benzodiazepines which include midazolam \& triazolam
* Individuals with any serious injury or surgery to the head or torso, or lower body in the last 6 months
* Individuals with a hearing impairment or hearing aids (due to the auditory stimulus recording being performed)
* Individuals who are currently pregnant
* Individuals with current litigation related to a physical, health-related injury
* Individuals who have been diagnosed with rheumatoid arthritis, osteoporosis or instability of the neck.
* Individuals with moderate to severe pain on a daily basis
* Pain on the day of testing rated greater than 3/10 on a visual analog scale (VAS)

Primary outcomes:
measure: Recruitment rate
timeFrame: through study completion, an average of 1 year
measure: Participant adherence rate
timeFrame: through study completion, an average of 1 year
measure: Participant tolerability rate
timeFrame: through study completion, an average of 1 year
measure: Participant retention rate
timeFrame: through study completion, an average of 1 year
measure: Acceptability of treatment regimen for participants
timeFrame: Week 6
Secondary outcomes:
measure: EEG resting state broadband power
timeFrame: Day 1
measure: EEG resting state broadband power
timeFrame: Week 2
measure: EEG resting state broadband power
timeFrame: Week 6
measure: EEG resting state functional connectivity
timeFrame: Day 1
measure: EEG resting state functional connectivity
timeFrame: Week 2
measure: EEG resting state functional connectivity
timeFrame: Week 6
measure: EEG evoked latency
timeFrame: Day 1
measure: EEG evoked latency
timeFrame: Week 2
measure: EEG evoked latency
timeFrame: Week 6
measure: EEG evoked amplitude
timeFrame: Day 1
measure: EEG evoked amplitude
timeFrame: Week 2
measure: EEG evoked amplitude
timeFrame: Week 6
measure: skin conductance level (SCL)
timeFrame: Day 1
measure: skin conductance level (SCL)
timeFrame: Week 2
measure: skin conductance level (SCL)
timeFrame: Week 6
measure: Impedance cardiogram (ICG) pre-ejection period (PEP)
timeFrame: Day 1
measure: Impedance cardiogram (ICG) pre-ejection period (PEP)
timeFrame: Week 2
measure: Impedance cardiogram (ICG) pre-ejection period (PEP)
timeFrame: Week 6
measure: ECG mean interbeat interval
timeFrame: Day 1
measure: ECG mean interbeat interval
timeFrame: Week 2
measure: ECG mean interbeat interval
timeFrame: Week 6
measure: ECG respiratory sinus arrhythmia (RSA)
timeFrame: Day 1
measure: ECG respiratory sinus arrhythmia (RSA)
timeFrame: Week 2
measure: ECG respiratory sinus arrhythmia (RSA)
timeFrame: Week 6
measure: ECG de-trended fluctuation analysis
timeFrame: Day 1
measure: ECG de-trended fluctuation analysis
timeFrame: Week 2
measure: ECG de-trended fluctuation analysis
timeFrame: Week 6
measure: Impedance cardiogram (ICG) initial systolic time interval (ISTI)
timeFrame: Day 1
measure: Impedance cardiogram (ICG) initial systolic time interval (ISTI)
timeFrame: Week 2
measure: Impedance cardiogram (ICG) initial systolic time interval (ISTI)
timeFrame: Week 6
measure: Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
timeFrame: Day 1
measure: Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
timeFrame: Week 2
measure: Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
timeFrame: Week 6
measure: Electrodermal activity (EDA) power spectral density (PSD)
timeFrame: Day 1
measure: Electrodermal activity (EDA) power spectral density (PSD)
timeFrame: Week 2
measure: Electrodermal activity (EDA) power spectral density (PSD)
timeFrame: Week 6
measure: Composite Autonomic Symptom Score (COMPASS-31)
timeFrame: Day 0
measure: Composite Autonomic Symptom Score COMPASS-31)
timeFrame: Day 1
measure: Composite Autonomic Symptom Score (COMPASS-31)
timeFrame: Week 2
measure: Composite Autonomic Symptom Score (COMPASS-31)
timeFrame: Week 6
measure: Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)
timeFrame: Day 0
measure: Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)
timeFrame: Day 1
measure: Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)
timeFrame: Week 2
measure: Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)
timeFrame: Week 6
measure: Perceived Stress Scale (PSS)
timeFrame: Day 0
measure: Perceived Stress Scale (PSS)
timeFrame: Day 1
measure: Perceived Stress Scale (PSS)
timeFrame: Week 2
measure: Perceived Stress Scale (PSS)
timeFrame: Week 6
Other outcomes:
Locations:
city: Marietta
country: United States
facility: Dr. Sid E. Williams Center for Chiropractic Research
state: Georgia
Study officials:
affiliation: Life University
name: Tyson Perez, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References: