Duchenne Muscular Dystrophy Clinical Trial

NCT01874275 | Completed Results

• 1 other identifier: VECTTOR DMD2012
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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. 1.increased muscle strength,
2. 2.increased range of joint motions and
3. 3.improved sleep parameters of ASI, N3 and REM.

Conditions

Duchenne Muscular Dystrophy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 180 days

Secondary Outcomes (3)

• Percent Change in Muscle Strength

  Baseline to 180 days

• Percent Change in Percent Range of Motion From Baseline to 365 Days

  Baseline to 365 days

• Percent Change in Muscle Strength

  Baseline to 365 days

Other Outcomes (2)

• Percent Change in Sleep Quality Arousal Statistics Index (ASI) From Baseline to 180 Days

  Baseline to 180 days

• Sleep Arousal Statistics Index at 365 Days

  Baseline to 365 days

Study Arms (2)

VECTTOR

EXPERIMENTAL

nerve stimulator treatment twice daily for duration of study - 365 days

Device: VECTTOR

Device - sham

PLACEBO COMPARATOR

placebo treatment - no electrical stimulation treatment twice daily for duration of study, 180 days - if VECTTOR arm experiencing improvement, subjects in Device-Sham arm will be crossed over into the VECTTOR group and followed for an additional 180 days, for a total study involvement (duration) of 365 days\>

Device: VECTTOR

Interventions

VECTTOR DEVICE

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.

Also known as: electrical nerve stimulator

Device - sham; VECTTOR

Eligibility Criteria

• Age: 8 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants must have Duchenne Muscular Dystrophy diagnosis as confirmed by licensed physician, wheelchair bound, \& age 8 - 20 years old.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alan Neuromedical Technologies, LLC: lead

Study Sites (1)

Alan Neuromedical

Houston, Texas, 77004, United States

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Charlotte Stelly-Seitz, MD
• Organization: Independent Principal Investigator

drstellyseitzmd@gmail.com

713-523-3463

Study Officials

• Charlotte Stelly-Seitz, MD

  Pediatric Physical Medicine and Rehabilitation Houston, Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2013
• First Posted: June 11, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 4, 2015
• Results First Posted: March 13, 2015

Record last verified: 2015-04

Locations

US (1)