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completed

Duchenne Muscular Dystrophy Clinical Trial

key information

study id #: NCT01874275

condition: Duchenne Muscular Dystrophy

status: completed

purpose:

The primary objective of this investigation is to assess the effectiveness of transcutaneous electrical nerve stimulation applied using VECTTOR to reduce the symptoms of Duchenne Muscular Dystrophy and reduce the impact of DMD upon the participants’ quality of life. The primary outcome measures will include: 1. increased muscle strength, 2. increased range of joint motions and 3. improved sleep parameters of ASI, N3 and REM.

intervention: VECTTOR

mechanism of action: Transcutaneous electrical nerve stimulation applied to reduce the symptoms of muscle weakness

results: https://clinicaltrials.gov/ct2/show/results/NCT01874275

last updated: November 22, 2018

study details

start date: June 2013

estimated completion: September 2014

phase of development: N/A

size / enrollment: 6

study description:
Muscle Strength and Joint Range of Motion Testing - All muscle and joint testing was performed at the MedCenter Therapy clinic in Houston, Texas. JTech computerized testing system was utilized including Goniometry, Grip testing, Inclinometry, Muscle Testing and Joint Range of Motion testing occurred on Day 0, 30, 60, 90, 180, and repeated at 12 months to determine muscular strength and joint Range of Motion. JTech computerized testing system was chosen on the basis of reliability and accuracy. At each of the testing intervals, the testing was administered by the same technician with the same equipment to all of the participants. Inter-and intra-tester reliability of the JTech computerized testing system has been the subject of multiple studies. Each of which found high ICCs (>0.93) for both inter- and intra-tester reliability.
All sleep studies were performed at Sleep Diagnostics of Texas in The Woodlands, Texas. Prior to the clinical trial, all of the participants spent two nights in the sleep unit and their sleep study examinations were performed. The second night was used as the Day 0 data. Sleep, breathing, arousals and limb movements were scored manually according to guidelines set forth by the American Academy of Sleep Medicine. The sleep studies were repeated at 6 months and 1 year.

primary outcomes:

  • Percent Change in Range of Motion From Baseline to 180 Days [ Time Frame: Baseline to 180 days ]
    Range of Motion (ROM) testing (Wireless Tracker System) - All muscle and joint testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90 and 180 days to determine changes in joint Range of Motion. JTech computerized testing system determined the joint range of motion by radio signals from a goniometer measuring movement of the participants' joints. 44 separate tests were performed for Range of Motion for each participant at each time interval. The results from the range of motion tests were averaged the percent change from baseline to 180 days. Efficacy is defined as an increase in range of motion.

secondary outcomes:

  • Percent Change in Muscle Strength [ Time Frame: Baseline to 180 days ]
    Muscle strength testing (Wireless Tracker system) - All muscle strength testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, and 180 days to determine changes in muscle strength. JTech computerized testing system determined the muscle strength by radio signals from a strain gauge measuring strength of the participant's muscles. 44 separate tests were performed for muscle strength for each participant at each time interval. Efficacy is defined as an increase in the strength measurement (pounds) from Baseline to 180 days.
  • Percent Change in Percent Range of Motion From Baseline to 365 Days [ Time Frame: Baseline to 365 days ]
    Range of Motion (ROM) testing (Wireless Tracker System) - All muscle and joint testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, 180 and 365 days to determine changes in joint Range of Motion. JTech computerized testing system determined the joint range of motion by radio signals from a goniometer measuring movement of the participants' joints. 44 separate tests were performed for Range of Motion for each participant at each time interval. The results from the range of motion tests were averaged the percent change from baseline to 365 days. Efficacy is defined as an increase in range of motion.
  • Percent Change in Muscle Strength [ Time Frame: Baseline to 365 days ]
    Muscle strength testing (Wireless Tracker system) - All muscle strength testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, 180 and 365 days to determine changes in muscle strength. JTech computerized testing system determined the muscle strength by radio signals from a strain gauge measuring strength of the participant's muscles. 44 separate tests were performed for muscle strength for each participant at each time interval. Efficacy is defined as an increase in the strength measurement (pounds) from Baseline to 365 days.

inclusion criteria:
Participants must have Duchenne Muscular Dystrophy diagnosis as confirmed by licensed physician, wheelchair bound, & age 8 - 20 years old.

exclusion criteria:
Active cancer in the area of application of the treatment, infection, skin infection, pregnancy, thrombophlebitis, pacemaker, amputation of any part of feet or hands, taking steroids. In addition, the participant may not be in any other clinical trial during the time they are in this study.

study contacts

sponsor: Alan Neuromedical Technologies, LLC

investigators: Charlotte Stelly-Seitz, MD

locations: United States