If you know anyone in the Houston, Texas general area; please let them know about this study.
By participating in this study, they will be able to keep a VECTTOR unit, help get this treatment approved for insurance reimbursement, and help prove the effectiveness of this treatment.
Defying Muscular Dystrophy Foundation and the Hope for Gabe Foundation will be sponsoring a double-blind, randomized, placebo-controlled trial of VECTTOR therapy for Duchenne Muscular Dystrophy in Houston, Texas, later this year. This trial will be held in cooperation with Alan Neuromedical Technologies and Dr. Donald A. Rhodes.
What is VECTTOR therapy?
VECTTOR therapy is a form of electrostimulation based upon acupuncture, reflexology, physiology, cellular physiology, and anatomy designed to stimulate the nerves to produce certain vital neuropeptides essential for optimal functioning of the body. VECTTOR therapy is non-invasive and the treatments are not painful. There are no known negative side-effects from VECTTOR therapy. However, the long-term use of electrostimulation has not been studied.
Who is eligible for this study?
The study will include up to 12 individuals with Duchenne Muscular Dystrophy, who are 20 years old or younger and who are non-ambulatory. Further screening criteria may include steroid usage, previous study participation, and prior muscle biopsies. The exclusion criterion includes individuals with a demand type cardiac pacemaker.
What will happen during this study?
Each participant will be randomly assigned either an active or a placebo VECTTOR system. The systems are visually indistinguishable but only the active unit will administer electrostimulation.
Each study participant and/or his caretaker will be trained to properly administer the VECTTOR treatments and will be able to do so in their own home. Support staff will be available for questions or concerns throughout the duration of the study.
How long with this study last?
The study will run for six months with a possible six month extension. For the first six months, the participants will be randomly divided into two equal, blinded groups. The first group will receive active VECTTOR treatments; the second group will receive inactive (placebo) treatments. The participants will receive various testing at weeks: 0, 4, 9, 13, and 26. At the end of the six month period, if the testing shows improvement in those participants receiving active treatment; all participants will receive active treatment for the 6 months extension and all testing will be repeated at the end of the second six months.
What will be required of the participants?
Each participant will be required to report to the testing center(s) in or around the greater Houston area at least 6 times, prior to, and throughout the duration of the study. Participants will be expected to administer VECTTOR therapy treatments twice per day for the first month and at least once per day for the remainder of the study. The units are equipped with tracking software to demonstrate compliancy and to collect treatment data.
Treatment data will be collected on an SD card installed in the VECTTOR system which will be downloaded, by the participants, to the study coordinator.
Where will the study take place?
All testing will be done in or around the greater Houston area.
Is there payment for participation?
There is no payment for participation, nor reimbursement for travel expenses. However, participants will be provided with all equipment, supplies and testing at no cost to them.
What testing will be performed?
Muscle strength testing and joint range of motion testing will be performed prior to beginning VECTTOR therapy and again at weeks: 4, 9, 13, and 26. If there is an extension phase of the study, the same testing will be repeated at the end of the second six months.
The presence of Deep Tendon Reflexes will be assessed prior to beginning treatment and again at weeks: 4, 9, 13, and 26. Provided there is a study extension, this test will be repeated at the end of the second six months.
Bone mineral densities will be obtained prior to beginning treatment and again at 26 weeks. Provided there is a study extension, this test will be repeated at the end of the second six months.
Physiological sleep studies will be obtained twice before beginning the study. The second study will be used as the baseline test. A follow up study will be obtained at week 26. If there is a study extension, this test will be repeated at the end of the second six months.
Echocardiograms will be obtained prior to beginning treatments, and again at week 26. Provided there is a study extension, this test will be repeated at the end of the second six months.
Pulmonary function testing will be obtained prior to beginning treatment and again at week 13 and week 26. Provided there is a study extension, this test will be repeated at the end of the second six months.
Eligible participants should contact VECTTORtrial@gmail.com for more information.