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Trial record 1 of 1 for:    vecttor
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Duchenne Muscular Dystrophy Clinical Trial (DMD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01874275
First Posted: June 11, 2013
Last Update Posted: May 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alan Neuromedical Technologies, LLC
Results First Submitted: November 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Duchenne Muscular Dystrophy
Intervention: Device: VECTTOR

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
VECTTOR

muscle stimulator treatment twice daily for duration of study - 365 days

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.

Device - Sham

placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by active treatment for the duration of study, 365 days

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.


Participant Flow:   Overall Study
    VECTTOR   Device - Sham
STARTED   4   2 
COMPLETED   3   2 
NOT COMPLETED   1   0 
Lost to Follow-up                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
VECTTOR - Active nerve stimulator treatment twice daily for duration of study - 365 days ...
Device Sham placebo treatment - no nerve stimulator treatment twice daily for 180 days of study
Total Total of all reporting groups

Baseline Measures
   VECTTOR - Active   Device Sham   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   2   6 
Age 
[Units: Participants]
     
<=18 years   4   2   6 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   4   2   6 
Region of Enrollment 
[Units: Participants]
     
United States   4   2   6 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change in Range of Motion From Baseline to 180 Days   [ Time Frame: Baseline to 180 days ]

2.  Secondary:   Percent Change in Muscle Strength   [ Time Frame: Baseline to 180 days ]

3.  Secondary:   Percent Change in Percent Range of Motion From Baseline to 365 Days   [ Time Frame: Baseline to 365 days ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title Percent Change in Percent Range of Motion From Baseline to 365 Days
Measure Description 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.
Time Frame Baseline to 365 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
VECTTOR 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.

Measured Values
   VECTTOR 
Participants Analyzed 
[Units: Participants]
 4 
Percent Change in Percent Range of Motion From Baseline to 365 Days 
[Units: Percentage of change]
Mean (Standard Deviation)
 59  (45.1) 

No statistical analysis provided for Percent Change in Percent Range of Motion From Baseline to 365 Days



4.  Secondary:   Percent Change in Muscle Strength   [ Time Frame: Baseline to 365 days ]

5.  Other Pre-specified:   Percent Change in Sleep Quality Arousal Statistics Index (ASI) From Baseline to 180 Days   [ Time Frame: Baseline to 180 days ]

6.  Other Pre-specified:   Sleep Arousal Statistics Index at 365 Days   [ Time Frame: Baseline to 365 days ]
Results not yet reported.   Anticipated Reporting Date:   03/2015  


  Serious Adverse Events


  Other Adverse Events
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Time Frame 1 year
Additional Description "0" means the total number of participants in which Serious and Others (Not including Serious) Adverse Events were not collected/assessed.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
VECTTOR nerve stimulator treatment twice daily for duration of study - 365 days ...
Device - Sham placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by cross-over with active treatment for the next 180 days

Other Adverse Events
    VECTTOR   Device - Sham
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   0/0   0/0 



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Charlotte Stelly-Seitz, MD
Organization: Independent Principal Investigator
phone: 713-523-3463
e-mail: drstellyseitzmd@gmail.com



Responsible Party: Alan Neuromedical Technologies, LLC
ClinicalTrials.gov Identifier: NCT01874275     History of Changes
Other Study ID Numbers: VECTTOR DMD2012
First Submitted: June 7, 2013
First Posted: June 11, 2013
Results First Submitted: November 4, 2014
Results First Posted: March 13, 2015
Last Update Posted: May 4, 2015