Clinical trial NCT01874275: Duchenne Muscular Dystrophy Clinical Trial
Official title: Double-blind, Randomized, Placebo-controlled Study of VECTTOR Treatment for Duchenne Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Duchenne Muscular Dystrophy
Lead sponsor: Alan Neuromedical Technologies, LLC
Sponsor class: INDUSTRY
First posted: 2013-06-11
Enrollment: 6
Sex: ALL
Minimum age (years): 8
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change in Range of Motion From Baseline to 180 Days
timeFrame: Baseline to 180 days
Secondary outcomes:
measure: Percent Change in Muscle Strength
timeFrame: Baseline to 180 days
measure: Percent Change in Percent Range of Motion From Baseline to 365 Days
timeFrame: Baseline to 365 days
measure: Percent Change in Muscle Strength
timeFrame: Baseline to 365 days
Other outcomes:
measure: Percent Change in Sleep Quality Arousal Statistics Index (ASI) From Baseline to 180 Days
timeFrame: Baseline to 180 days
measure: Sleep Arousal Statistics Index at 365 Days
timeFrame: Baseline to 365 days
Locations:
city: Houston
country: United States
facility: Alan Neuromedical
state: Texas
Study officials:
affiliation: Pediatric Physical Medicine and Rehabilitation Houston, Texas
name: Charlotte Stelly-Seitz, MD
role: PRINCIPAL_INVESTIGATOR
References: