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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

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
Enrollment 6

Recruitment Details  
Pre-assignment Details  
Arm/Group Title VECTTOR Device - Sham
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 4 2
Completed 3 2
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Arm/Group Title VECTTOR - Active Device Sham Total
Hide Arm/Group Description nerve stimulator treatment twice daily for duration of study - 365 days ... placebo treatment - no nerve stimulator treatment twice daily for 180 days of study Total of all reporting groups
Overall Number of Baseline Participants 4 2 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 participants
<=18 years
4
 100.0%
2
 100.0%
6
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
4
 100.0%
2
 100.0%
6
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 2 participants 6 participants
4 2 6
1.Primary Outcome
Title Percent Change in Range of Motion From Baseline to 180 Days
Hide 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 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.
Time Frame Baseline to 180 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VECTTOR Device - Sham
Hide Arm/Group Description:
nerve stimulator treatment twice daily for duration of study - assessed at 180 days
placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by cross-over with active treatment for the next 180 days
Overall Number of Participants Analyzed 4 2
Mean (Standard Deviation)
Unit of Measure: percentage of change
67  (44.3) 33  (49.2)
2.Secondary Outcome
Title Percent Change in Muscle Strength
Hide Description 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.
Time Frame Baseline to 180 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VECTTOR Device - Sham
Hide Arm/Group Description:
nerve stimulator treatment twice daily for duration of study
placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by muscle stimulator treatment twice daily for 180 days
Overall Number of Participants Analyzed 4 2
Mean (Standard Deviation)
Unit of Measure: percentage of change
95  (2.16) 48  (1.08)
3.Secondary Outcome
Title Percent Change in Percent Range of Motion From Baseline to 365 Days
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VECTTOR
Hide Arm/Group 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.
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: percentage of change
59  (45.1)
4.Secondary Outcome
Title Percent Change in Muscle Strength
Hide Description 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.
Time Frame Baseline to 365 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VECTTOR
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: percentage of change
110  (1.93)
5.Other Pre-specified Outcome
Title Percent Change in Sleep Quality Arousal Statistics Index (ASI) From Baseline to 180 Days
Hide Description 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.
Time Frame Baseline to 180 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VECTTOR Device - Sham
Hide Arm/Group Description:

nerve stimulator treatment twice daily for duration of study - 180 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.

placebo treatment - no electrical stimulation treatment twice daily for 180 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.

Overall Number of Participants Analyzed 4 2
Mean (Standard Deviation)
Unit of Measure: percentage of change
38  (1.31) -53  (1.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VECTTOR, Device - Sham
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2413
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
6.Other Pre-specified Outcome
Title Sleep Arousal Statistics Index at 365 Days
Hide Description 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.
Time Frame Baseline to 365 days
Outcome Measure Data Not Reported
Time Frame 1 year
Adverse Event Reporting Description "0" means the total number of participants in which Serious and Others (Not including Serious) Adverse Events were not collected/assessed.
 
Arm/Group Title VECTTOR Device - Sham
Hide Arm/Group Description nerve stimulator treatment twice daily for duration of study - 365 days ... placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by cross-over with active treatment for the next 180 days
All-Cause Mortality
VECTTOR Device - Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
VECTTOR Device - Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
VECTTOR Device - Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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
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