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Innovative Imaging of Cerebrum and Muscle (iCAM) Repeatability Study (iCAM)

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ClinicalTrials.gov Identifier: NCT03548168
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Ohio University

Brief Summary:
Impairments in postural control are linked to low back pain and reductions in physical function in the elderly. Unfortunately, many techniques to assess the neural control of movement are not feasible, or directly applicable, to the trunk musculature. In a prior pilot study, we developed and optimized innovative approaches to study these muscles. We will continue to develop a reliable, fMRI protocol that investigates the activity of the motor cortical networks of selected trunk muscles (specific aim 1). We will also continue the development a reliable muscle functional MRI (mfMRI) protocol to assess the spatial muscle activation patterns of the deeper lumbopelvic muscles (specific aim 2). We will examine the test-retest reliability of these approaches in four distinct target populations: healthy adults, adults with chronic low back pain, older adults, and older adults with high levels of trunk muscle control (i.e., individuals with expertise in Pilates). By enrolling groups of various levels of trunk muscle control, pathology state and age, we will be able to not only determine the intra-individual reliability, but also the inter-individual reliability as we expect the variability of the measures to be influenced by physical ability, pain state and age. Lastly, in an exploratory aim we will examine the association of our novel neurophysiological measures from Aim 1 and 2 with classic biomechanical and muscle function measures (e.g., trunk extensor strength and trunk extensor steadiness). Successfully developing reliable techniques of this nature will result in new and improved research tools for conducting rigorous studies of therapeutic approaches, such as spinal manipulation and yoga, within the context of trunk muscle control and function.

Condition or disease
Low Back Pain Aging

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 32 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Innovative Neurophysiological Techniques for Assessing Trunk Muscle Control and Function (iCAM)
Actual Study Start Date : May 18, 2018
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Group/Cohort
Healthy Adults
Eligible healthy young adults, aged 18-30 years, will participate in testing experiments to test-retest reliability of the muscle functional magnetic resonance imaging (mfMRI) and functional magnetic resonance imaging (fMRI) techniques that were developed in order to study the neural control of trunk muscles.
Low Back Pain
Eligible young adults, aged 18-30 years, with chronic low back pain will participate in testing experiments to test-retest reliability of the muscle functional magnetic resonance imaging (mfMRI) and functional magnetic resonance imaging (fMRI) techniques that were developed in order to study the neural control of trunk muscles.
Older Adults
Eligible healthy middle aged and older adults, aged 55 years and older, will participate in testing experiments to test-retest reliability of the muscle functional magnetic resonance imaging (mfMRI) and functional magnetic resonance imaging (fMRI) techniques that were developed in order to study the neural control of trunk muscles.
Trunk Experts
Eligible healthy middle aged and older adults, aged 55 years and older, with high levels of trunk muscle control (ie. individuals with expertise in the Pilates Method of exercise) will participate in testing experiments to test-retest reliability of the muscle functional magnetic resonance imaging (mfMRI) and functional magnetic resonance imaging (fMRI) techniques that were developed in order to study the neural control of trunk muscles.



Primary Outcome Measures :
  1. Trunk extensor fMRI signal intensity [ Time Frame: 3 years ]
    Physiological measure of brain efficiency in activating the trunk muscles



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Young healthy adults, young healthy adults with chronic low back pain, healthy middle aged/older adults, and health middle aged/older adults with high levels of trunk muscle control.
Criteria
  1. Healthy young adults Eligible subjects are males and females aged 18-30 years with no significant health issues

    Inclusion Criteria:

    A subject must meet the following criteria to be eligible for inclusion in the study:

    • Men and women aged 18- 30 years, with no significant health issues or conditions that, in the investigator's opinion, would limit the subject's ability to complete the study activities or that would impact the capability to get an accurate measurement of study endpoints.
    • Body mass index (BMI) between 17 and 30 kg/m2.
    • Willing to undergo multiple MRI sessions.
    • Willing and able to return for all visits and complete all study-related activities.
    • Able to read, understand, and complete study-related questionnaires
    • Able to read and understand, and willing to sign the informed consent form (ICF).

    Exclusion criteria:

    A subject who meets any of the following criteria will be excluded from the study:

    • Having body dimensions that exceed the MRI or exercise equipment limits.
    • Unable to undergo MRI (e. g. body containing any metallic medical devices or equipment, including heart pacemakers, metal prostheses, implants or surgical clips, any prior injury from shrapnel or grinding metal, exposure to metallic dusts, metallic shavings or having tattoos containing metallic dyes)
    • Abnormal or uncontrolled blood pressure at the screening visit defined as BP > 180/100 mmHg.
    • Positive pregnancy test.
    • Having a personal history of the following neurological disorders: Alzheimers, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinsons, Stroke
    • Having a personal history of the following cardiorespiratory disorders: Congestive heart failure, Heart attack in past 24 months
    • Having a personal history of the following musculoskeletal disorders: Rheumatoid Arthritis, pathologic fractures of the spine, avascular necrosis or osteonecrosis, severe osteoarthritis. Including a history of spine surgery or a hip arthroplasty.
    • Having neurological symptoms (ie. burning, numbness, tingling sensations into the legs), muscle weakness associated with neural dysfunction (i.e. foot drop), or episodes of incontinence of bowel or bladder.
    • Having active cancer
    • Blindness
    • Having used opioids or muscle relaxants within 30 days prior to study enrollment.
    • Reports being pregnant, lactating, or that they anticipate becoming pregnant in the next 3-months. If a woman becomes pregnant while on study protocol they will be withdrawn from the study.
    • Reports unexplained weight loss over the past month (greater than 10 lbs).
    • Failure to provide informed consent.
  2. Young adults with chronic low back pain (CLBP) Eligible subjects are males and females aged 18- 30 years with no significant health issues except self report of CLBP

    Inclusion Criteria:

    A subject must meet the following criteria to be eligible for inclusion in the study:

    • Men and women aged 18- 30 years, with no significant health issues or conditions that, in the investigator's opinion, would limit the subject's ability to complete the study activities or that would impact the capability to get an accurate measurement of study endpoints.
    • Body mass index (BMI) between 17 and 30 kg/m2.
    • Willing to undergo multiple MRI sessions.
    • Willing and able to return for all visits and complete all study-related activities.
    • Able to read, understand, and complete study-related questionnaires.
    • Able to read and understand, and willing to sign the informed consent form (ICF).
    • Reports average pain intensity (assessed using the Numerical Pain Rating (NPRS) scale) over the past week greater than or equal to 3 on a 0-10 numerical pain scale.
    • Oswestry Low Back Pain Disability Questionnaire score > 20% (moderate disability and above).
    • Answers yes to the following questions:

    Have you had low back pain constantly or on most days for the last three months? Has your back pain caused you to seek care or consultation from a health care provider?

    Exclusion criteria:

    A subject who meets any of the following criteria will be excluded from the study:

    • Having body dimensions that exceed the MRI or exercise equipment limits.
    • Unable to undergo MRI (e. g. body containing any metallic medical devices or equipment, including heart pacemakers, metal prostheses, implants or surgical clips, any prior injury from shrapnel or grinding metal, exposure to metallic dusts, metallic shavings or having tattoos containing metallic dyes)
    • Abnormal or uncontrolled blood pressure at the screening visit defined as BP > 180/100 mmHg.
    • Positive pregnancy test.
    • Having a personal history of the following neurological disorders: Alzheimers, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinsons, Stroke
    • Having a personal history of the following cardiorespiratory disorders: Congestive heart failure, Heart attack in past 24 months
    • Having a personal history of the following musculoskeletal disorders: Rheumatoid Arthritis, pathologic fractures of the spine, avascular necrosis or osteonecrosis, severe osteoarthritis. Including a history of spine surgery or a hip arthroplasty
    • Having neurological symptoms (ie. burning, numbness, tingling sensations into the legs), muscle weakness associated with neural dysfunction (i.e. foot drop), or episodes of incontinence of bowel or bladder
    • Having active cancer
    • Blindness
    • Having used opioids or muscle relaxants within 30 days prior to study enrollment.
    • Reports being pregnant, lactating, or that they anticipate becoming pregnant in the next 3-months. If a woman becomes pregnant while on study protocol they will be withdrawn from the study.
    • Reports unexplained weight loss over the past month (greater than 10 lbs).
    • Reports having pending litigation related to an episode of LBP or are receiving any type of disability services related to low back pain.
    • Reports having received any manual therapy intervention applied to the spine 30 days prior to first study intervention.
    • Reports current drug or alcohol use or dependence that, in the opinion of the PIs, would interfere with adherence to study requirements.
    • Failure to provide informed consent.
  3. Healthy middle-aged and older adults Eligible subjects are males and females aged 55+ years with no significant health issues

    Inclusion Criteria:

    A subject must meet the following criteria to be eligible for inclusion in the study:

    • Men and women over 55 years of age, with no significant health issues or conditions that, in the investigator's opinion, would limit the subject's ability to complete the study activities or that would impact the capability to get an accurate measurement of study endpoints.
    • Body mass index (BMI) between 17 and 30 kg/m2.
    • Willing to undergo multiple MRI sessions.
    • Willing and able to return for all visits and complete all study-related activities.
    • Able to read, understand, and complete study-related questionnaires
    • Able to read and understand, and willing to sign the informed consent form (ICF).

    Exclusion criteria:

    A subject who meets any of the following criteria will be excluded from the study:

    • Having body dimensions that exceed the MRI or exercise equipment limits.
    • Unable to undergo MRI (e. g. body containing any metallic medical devices or equipment, including heart pacemakers, metal prostheses, implants or surgical clips, any prior injury from shrapnel or grinding metal, exposure to metallic dusts, metallic shavings or having tattoos containing metallic dyes)
    • Abnormal or uncontrolled blood pressure at the screening visit defined as BP > 180/100 mmHg.
    • Positive pregnancy test.
    • Having a personal history of the following neurological disorders: Alzheimers, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinsons, Stroke
    • Having a personal history of the following cardiorespiratory disorders: Congestive heart failure, Heart attack in past 24 months
    • Having a personal history of the following musculoskeletal disorders: Rheumatoid Arthritis, pathologic fractures of the spine, avascular necrosis or osteonecrosis, severe osteoarthritis. Including a history of spine surgery or a hip arthroplasty
    • Having neurological symptoms (ie. burning, numbness, tingling sensations into the legs), muscle weakness associated with neural dysfunction (i.e. foot drop), or episodes of incontinence of bowel or bladder
    • Having active cancer
    • Blindness
    • Having used opioids or muscle relaxants within 30 days prior to study enrollment.
    • Reports being pregnant, lactating, or that they anticipate becoming pregnant in the next 3-months. If a woman becomes pregnant while on study protocol they will be withdrawn from the study.
    • Reports unexplained weight loss over the past month (greater than 10 lbs).
    • Failure to provide informed consent.
  4. Healthy middle-aged and older adults with high levels of trunk muscle control (ie. individuals with expertise in the Pilates Method of exercise)

Eligible subjects are males and females aged 55+ years with no significant health issues

Inclusion Criteria:

A subject must meet the following criteria to be eligible for inclusion in the study:

  • Men and women over 55 years of age, with no significant health issues or conditions that, in the investigator's opinion, would limit the subject's ability to complete the study activities or that would impact the capability to get an accurate measurement of study endpoints.
  • Reports being trained in the Pilates method exercises and has been performing these exercises 2 times per week for the past one year.
  • Body mass index (BMI) between 17 and 30 kg/m2.
  • Willing to undergo multiple MRI sessions.
  • Willing and able to return for all visits and complete all study-related activities.
  • Able to read, understand, and complete study-related questionnaires
  • Able to read and understand, and willing to sign the informed consent form (ICF).

Exclusion criteria:

A subject who meets any of the following criteria will be excluded from the study:

  • Having body dimensions that exceed the MRI or exercise equipment limits.
  • Unable to undergo MRI (e. g. body containing any metallic medical devices or equipment, including heart pacemakers, metal prostheses, implants or surgical clips, any prior injury from shrapnel or grinding metal, exposure to metallic dusts, metallic shavings or having tattoos containing metallic dyes)
  • Abnormal or uncontrolled blood pressure at the screening visit defined as BP > 180/100 mmHg.
  • Positive pregnancy test.
  • Having a personal history of the following neurological disorders: Alzheimers, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinsons, Stroke
  • Having a personal history of the following cardiorespiratory disorders: Congestive heart failure, Heart attack in past 24 months
  • Having a personal history of the following musculoskeletal disorders: Rheumatoid Arthritis, pathologic fractures of the spine, avascular necrosis or osteonecrosis, severe osteoarthritis. Including a history of spine surgery or a hip arthroplasty
  • Having neurological symptoms (ie. burning, numbness, tingling sensations into the legs), muscle weakness associated with neural dysfunction (i.e. foot drop), or episodes of incontinence of bowel or bladderHaving active cancer
  • Blindness
  • Having used opioids or muscle relaxants within 30 days prior to study enrollment.
  • Reports being pregnant, lactating, or that they anticipate becoming pregnant in the next 3-months. If a woman becomes pregnant while on study protocol they will be withdrawn from the study.
  • Reports unexplained weight loss over the past month (greater than 10 lbs).
  • Failure to provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548168


Contacts
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Contact: Brian Clark, PhD 740-593-2354 clarkb2@ohio.edu

Locations
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United States, Ohio
Ohio Musculoskeletal and Neurological Institute (OMNI) at Ohio University Recruiting
Athens, Ohio, United States, 45701
Contact: Brian C Clark, PhD    740-593-2354    clarkb2@ohio.edu   
Principal Investigator: Brian Clark, PhD         
Sub-Investigator: Leatha Clark, PT, PhD         
Sub-Investigator: Dustin Grooms, PhD, ATC         
Sub-Investigator: Timothy Law, DO, MBA         
Sub-Investigator: Rachel Clift, MSN, RN         
Sub-Investigator: Dallin Tavoian         
Sub-Investigator: Nathan Wages         
Sub-Investigator: Elizabeth Sares         
Sponsors and Collaborators
Ohio University
Investigators
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Principal Investigator: Brian Clark, PhD Ohio Musculoskeletal and Neurological Institute

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Responsible Party: Ohio University
ClinicalTrials.gov Identifier: NCT03548168     History of Changes
Other Study ID Numbers: 17-F-23
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms