Duchenne Muscular Dystrophy Clinical Trial

NCT01874275 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2015-05-04

Study results available
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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.

Conditions

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Alan Neuromedical Technologies, LLC

    lead INDUSTRY

Principal Investigators

  • Charlotte Stelly-Seitz, MD · Pediatric Physical Medicine and Rehabilitation Houston, Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01874275 on ClinicalTrials.gov