Duchenne Muscular Dystrophy
Conditions
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.
Interventions
DEVICEVECTTOR
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.
Sponsors
Alan Neuromedical Technologies, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 20 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Range of Motion From Baseline to 180 Days | 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
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Muscle Strength | 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Sleep Quality Arousal Statistics Index (ASI) From Baseline to 180 Days | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VECTTOR - Active nerve stimulator treatment twice daily for duration of study - 365 days ... | 4 |
| Device Sham placebo treatment - no nerve stimulator treatment twice daily for 180 days of study | 2 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | VECTTOR - Active | Device Sham | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 2 Participants | 6 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 4 participants | 2 participants | 6 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Percent Change in Range of Motion From 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.
Time frame: Baseline to 180 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VECTTOR | Percent Change in Range of Motion From Baseline to 180 Days | 67 percentage of change | Standard Deviation 44.3 |
| Device - Sham | Percent Change in Range of Motion From Baseline to 180 Days | 33 percentage of change | Standard Deviation 49.2 |
Secondary
Percent Change in Muscle Strength
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VECTTOR | Percent Change in Muscle Strength | 95 percentage of change | Standard Deviation 2.16 |
| Device - Sham | Percent Change in Muscle Strength | 48 percentage of change | Standard Deviation 1.08 |
Secondary
Percent Change in Muscle Strength
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VECTTOR | Percent Change in Muscle Strength | 110 percentage of change | Standard Deviation 1.93 |
Secondary
Percent Change in Percent Range of Motion From 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.
Time frame: Baseline to 365 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VECTTOR | Percent Change in Percent Range of Motion From Baseline to 365 Days | 59 percentage of change | Standard Deviation 45.1 |
Other Pre-specified
Percent Change in Sleep Quality Arousal Statistics Index (ASI) From 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.
Time frame: Baseline to 180 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VECTTOR | Percent Change in Sleep Quality Arousal Statistics Index (ASI) From Baseline to 180 Days | 38 percentage of change | Standard Deviation 1.31 |
| Device - Sham | Percent Change in Sleep Quality Arousal Statistics Index (ASI) From Baseline to 180 Days | -53 percentage of change | Standard Deviation 1.77 |
p-value: 0.2413Mixed Models Analysis
Other Pre-specified
Sleep Arousal Statistics Index at 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.
Time frame: Baseline to 365 days