Magnetic Resonance and Optical Imaging of Dystrophic and Damaged Muscle

NCT02168114 | Completed

• 3 other identifiers: IRB201602354MD110050536-2012
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine the potential of Optical Imaging techniques to detect muscle damage in boys with Duchenne Muscular Dystrophy and unaffected exercised muscle. Healthy subjects will undergo two different exercises in opposite forearms before any imaging techniques are performed. Boys with Duchenne Muscular Dystrophy will only undergo the imaging techniques without exercise.

Conditions

Duchenne Muscular Dystrophy

Keywords

Duchenne Muscular Dystrophy; Exercise; Optical Imaging; Magnetic Resonance

Outcome Measures

Primary Outcomes (2)

• Indocyanine Green accumulation in forearm muscles

  Percentage of area with elevated Indocyanine Green in muscle will be an indicator of cell membrane damage and will be measured using Optical Imaging in the forearms of study participants.

  Up to 2 days

• Muscle T2 elevation in forearm muscles

  Muscle T2 is a noninvasive marker of muscle damage/inflammation and will be measured using Magnetic Resonance in the forearms of participants of this study.

  Up to 2 days

Secondary Outcomes (2)

• Delayed Onset of Muscle Soreness (DOMS)

  Up to 2 days

• Serum Creatine Kinase

  Up to 2 days

Study Arms (2)

Duchenne Muscular Dystrophy

EXPERIMENTAL

This arm will only include subjects that have a confirmed diagnosis of Duchenne Muscular Dystrophy. Subjects in this arm will not undergo any exercising, and will only be imaged by Optical and Magnetic Resonance Imaging and Spectroscopy techniques at a single time point.

Procedure: Optical and Magnetic Resonance Imaging and Spectroscopy

Non-affected Subjects

EXPERIMENTAL

This arm will contain subjects that are not affected by Duchenne Muscular Dystrophy. These subjects will undergo concentric exercising of one forearm, and eccentric exercising of the contralateral forearm. Two days following the exercising, subjects will undergo Optical Imaging and Magnetic Resonance Imaging and Spectroscopy.

Other: Exercising; Procedure: Optical and Magnetic Resonance Imaging and Spectroscopy

Interventions

Exercising OTHER

This arm will only include subjects that have a confirmed diagnosis of Duchenne Muscular Dystrophy. Subjects in this arm will not undergo any exercising, and will only be imaged by Optical and Magnetic Resonance Imaging and Spectroscopy techniques at a single time point.

Non-affected Subjects

Optical and Magnetic Resonance Imaging and Spectroscopy PROCEDURE

This arm will contain subjects that are not affected by Duchenne Muscular Dystrophy. These subjects will undergo concentric exercising of one forearm, and eccentric exercising of the contralateral forearm. Two days following the exercising, subjects will undergo Optical Imaging and Magnetic Resonance Imaging and Spectroscopy.

Duchenne Muscular Dystrophy; Non-affected Subjects

Eligibility Criteria

• Age: 10 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of Duchenne muscular dystrophy confirmed by 1) clinical history with features before the age of 5 years, 2) physical examination, 3) elevated serum creatine kinase level, and 4) absence of dystrophin expression as determined by immune stain or Wester blot (\<2%) and/or DNA confirmation of dystrophin mutation
• Must be between 10-15 years of age.
• Must be male.
• Must be older than 18 years of age.
• Must be male.

You may not qualify if:

• Contraindication to an Magnetic Resonance examination (e.g. aneurysm clip, severe claustrophobia, magnetic implants)
• Presence of a condition in patients that impacts muscle function or muscle metabolism (e.g. myasthenia gravis, endocrine disorder, mitochondrial disease)
• Medical condition leading to developmental delay or impaired motor control (e.g. cerebral palsy)
• Unstable medical condition (e.g. uncontrolled seizure disorder)
• Behavioral problems causing an inability to cooperate during testing
• Control subjects who are participating in sport specific training 2 times or more per week
• History of allergy to iodides

Sponsors & Collaborators

• University of Florida: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne; Motor Activity

Interventions

Magnetic Resonance Spectroscopy; Spectrum Analysis

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Glenn A Walter, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 20, 2014
• Study Start: July 1, 2014
• Primary Completion: January 8, 2018
• Study Completion: January 8, 2018
• Last Updated: January 12, 2018

Record last verified: 2018-01

Locations

US (1)