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Duchenne Muscular Dystrophy Clinical Trial (DMD)

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ClinicalTrials.gov Identifier: NCT01874275
Recruitment Status : Completed
First Posted : June 11, 2013
Results First Posted : March 13, 2015
Last Update Posted : May 4, 2015
Sponsor:
Information provided by (Responsible Party):
Alan Neuromedical Technologies, LLC

Tracking Information
First Submitted Date  ICMJE June 7, 2013
First Posted Date  ICMJE June 11, 2013
Results First Submitted Date  ICMJE November 4, 2014
Results First Posted Date  ICMJE March 13, 2015
Last Update Posted Date May 4, 2015
Study Start Date  ICMJE June 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2013)
Increased range of motion [ Time Frame: measurements aassessed at intervals of 30, 60, 90, 180 and 360 days ]
Range of motion testing (Wireless Tracker System)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2013)
Increased muscle strength [ Time Frame: measurement assessed at intervals of 30, 60, 90 180 and 360 days ]
Muscle strength testing (Wireless Tracker system)
Current Other Pre-specified Outcome Measures
 (submitted: March 12, 2015)
  • Percent Change in Sleep Quality Arousal Statistics Index (ASI) From Baseline to 180 Days [ Time Frame: Baseline to 180 days ]
    Sleep / Arousal Statistics Index (ASI) description: Sleep Studies were obtained twice before beginning the study. The second sleep study data was used as baseline. A follow up sleep study was obtained after 6 months (180 days) of Active or Placebo VECTTOR treatment. Sleep, breathing, arousal(s), and limb movements were scored manually according to guidelines of the American Academy of Sleep Medicine. The efficacy of the outcome measure of ASI is demonstrated by a percent improvement between Baseline and 180 days. The ASI is measured by the number of times sleep is interrupted per hour.
  • Sleep Arousal Statistics Index at 365 Days [ Time Frame: Baseline to 365 days ]
    Sleep / Arousal Statistics Index (ASI) description: Sleep Studies were obtained twice before beginning the study. The second sleep study data was used as baseline. A follow up sleep study was obtained after 6 months (180 days) of Active or Placebo VECTTOR treatment. Sleep, breathing, arousal(s), and limb movements were scored manually according to guidelines of the American Academy of Sleep Medicine. The efficacy of the outcome measure of ASI is demonstrated by a decrease in the value between Baseline and 180 days. The ASI is measured by the number of times sleep is interrupted per hour. Lower ASI values/numbers indicate improved sleep quality.
Original Other Pre-specified Outcome Measures
 (submitted: June 10, 2013)
improvement of sleep quality [ Time Frame: assessed at 90, 180 and 365 days ]
Sleep Studies will be obtained twice before beginning the study. The second study will be used as the baseline test.
 
Descriptive Information
Brief Title  ICMJE Duchenne Muscular Dystrophy Clinical Trial
Official Title  ICMJE Double-blind, Randomized, Placebo-controlled Study of VECTTOR Treatment for Duchenne Muscular Dystrophy
Brief Summary

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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Duchenne Muscular Dystrophy
Intervention  ICMJE Device: VECTTOR

The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient's feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.

Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence.

Other Name: electrical nerve stimulator
Study Arms  ICMJE
  • Experimental: VECTTOR
    nerve stimulator treatment twice daily for duration of study - 365 days
    Intervention: Device: VECTTOR
  • Placebo Comparator: Device - sham
    placebo treatment - no electrical stimulation treatment twice daily for duration of study, 180 days - if VECTTOR arm experiencing improvement, subjects in Device-Sham arm will be crossed over into the VECTTOR group and followed for an additional 180 days, for a total study involvement (duration) of 365 days>
    Intervention: Device: VECTTOR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2014)
6
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2013)
12
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01874275
Other Study ID Numbers  ICMJE VECTTOR DMD2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alan Neuromedical Technologies, LLC
Study Sponsor  ICMJE Alan Neuromedical Technologies, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Charlotte Stelly-Seitz, MD Pediatric Physical Medicine and Rehabilitation Houston, Texas
PRS Account Alan Neuromedical Technologies, LLC
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP