N/A N=6 Randomized Quadruple-blind Treatment

Duchenne Muscular Dystrophy Clinical Trial

Duchenne Muscular Dystrophy

Bottom Line

View on ClinicalTrials.gov: NCT01874275 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Mar 2015

Primary outcome: Primary: Percent Change in Range of Motion From Baseline to 180 Days — 67; 33 percentage of change

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: VECTTOR (Device)
Age: Pediatric, Adult · 8+ yrs
Sex: All
Sponsor: Alan Neuromedical Technologies, LLC
Primary completion: Sep 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Range of Motion From Baseline to 180 Days	67; 33	—
SECONDARY Percent Change in Muscle Strength	110	—
SECONDARY Percent Change in Percent Range of Motion From Baseline to 365 Days	59	—
SECONDARY Percent Change in Muscle Strength	110	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01874275). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.