Duchenne Muscular Dystrophy Clinical Trial (DMD)

Alan Neuromedical Technologies

Status: Completed

Conditions: Duchenne Muscular Dystrophy

Treatments: Device: VECTTOR

Study type: Interventional

Funder types: Industry

Identifiers

NCT01874275

VECTTOR DMD2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 8 to 20 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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6 participants in 2 patient groups, including a placebo group

VECTTOR

Experimental group

Description:

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

Treatment:

Device: VECTTOR

Device - sham

Placebo Comparator group

Description:

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\>

Treatment:

Device: VECTTOR