Alan Neuromedical

Technologies

2002 Timberloch Place

The Woodlands, TX 77380

www.VECTTOR.com

VECTTORInfo@gmail.com

Tel: 281-259-8563

Fax: 888-501-5518

 

The VECTTOR

Therapy System

is available by

prescription only

 

 

MKT-003 Rev B

ECN 15-011


 

 

 The VECTTOR Therapy System is indicated in the United States for the treatment of chronic, intractable pain and for the treatment of post-surgical trauma pain.    Any other use of the VECTTOR Therapy System would be considered off-label use.


The results detailed on this page are from the first 6 months of the study (active/placebo). We have been asked to submit these results before submitting the results for the second half of the study (active/active). We will submit these results to ClinicalTrials.gov as soon as we are permitted, and will post the results here as soon as they are accepted. The 12 month results will include additional data including cardiac, and sleep testing.

 

We would like to extend our appreciation to the clinicians who assisted in this clinical trial, and a special thank you to the Hope for Gabe and Defying Muscular Dystrophy foundations for their support. Most importantly, we want to express our heartfelt gratitude to the young men who participated in this study, and to their families. We were honored to come to know each of you, and we are indebted to you for your commitment and dedication to this trial.

 


The 2013-14 double-blind, randomized, placebo controlled clinical trial, utilizing VECTTOR Therapy, for non-ambulatory children with Duchenne Muscular Dystrophy (DMD), completed its first year in September 2014. The trial has been extended for a second year.

 

It is respectfully acknowledged that the study size is very small, as available resources were limited. The intent of this study was to demonstrate the need for further investigation of VECTTOR Therapy for the treatment of Duchenne Muscular Dystrophy.

 

 

Study Details:

 

A total of 5 male children were included in this double-blind, randomized, placebo-controlled study. 6 participants were originally enrolled, however, Participant #6 withdrew due to family difficulties with travel requirements associated with the study.

 

All participants had been previously diagnosed with Duchenne Muscular Dystrophy based upon clinical examination and creatine phosphokinase analysis. The primary end points for the study were joint range of motion and muscle strength. At the beginning of the study, the children’s ages ranged from 8 to 16, with the average age of 11 years old. The participants were randomized 66.7/33.3 Active/Placebo. Utilizing independent randomization, four of the six participants were assigned to the Active group and two were assigned to the Placebo group.

 

Due to randomization, only 2 of the 6 participants were given Placebo treatments. It happened that the Placebo participants were among the youngest in the study. The study was originally intended for older children with DMD. However, resources for recruiting subjects were limited, and decreasing the age requirement became necessary in order to obtain enough participants. 

 

During the first six months, 4 of the children received Active VECTTOR therapy while 2 of the children received Placebo VECTTOR Therapy. All participants received Active VECTTOR Therapy for the second six months of the study.

 

There were no adverse events reported during this study.

 

Demographics of Study Participants
Subject #   Group

 

D.O.B.

 

Steroid Use
1    Active      5/97 Never
2    Active   12/00   5 mg Prednisone/day*
3    Active 12/04 Never
4    Placebo 9/03 24 mg Deflazacort/day
5    Placebo 8/03 Never
6**    Active 1/04 15 mg Prednisone/day

*Subject #2 was taking 20 mg of Prednisone per day, on Day 0. Within the first month of the study, his parents decreased the Prednisone to 5 mg per day, without the knowledge or consent of the principal investigator. This participant continued on 5 mg of Prednisone per day for the duration of the study.

 

**Subject #6 withdrew from the study due to family difficulties associated with travel required for the study.

 

Endpoint Testing and Evaluations

Physical Evaluations

 

At each testing interval, subjects were evaulated by the principal investigator of the study, Dr. Stelly-Seitz. Dr. Stelly-Seitz is a pediatric physiatrist who practices in the Houston area. 

 

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, all of which found high ICCs (>0.93) for both inter- and intra-tester reliability.

 

Sleep Studies

 

All sleep studies were performed at Sleep Diagnostics of Texas in The Woodlands, Texas. Prior to beginning treatment, 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.

 

Pulmonary Monitoring 

 

Pulmonary function testing was performed at the Texas Institute of Pulmonary and Sleep Medicine in Tomball, Texas, by the same Licensed Certified Pulmonary Function Technologist utilizing the same equipment, at each testing interval. The testing was performed utilizing the Collins ”Owl Digital Plethysmography with Diffusion Pulmonary Function Testing System". The Predicated Protocol is from authors used in the Collins “1” Table. The testing included FVC (Forced Vital Capacity), FEV1 (Volume that has been exhaled at the end of the first second of forced expiration), FEV1/VFC (The proportion of vital capacity in the first second of expiration), and FEF Max (The maximum instantaneous flow achieved during a FVC test). 

 

Cardiac Monitoring 

 

Cardiac monitoring was performed at Village Park Cardiology in Houston, Texas. The echo cardiogram testing included ejection fraction, left ventricle, left atrium, right ventricle, right atrium, aortic valve, mitral valve, tricuspid valve, pulmonic valve, pericardium, and aorta.

 

 

 

Strength Testing 

Averaged Results

 

 

Average strength increase of the lower body extremities for those subjects receiving Active and Placebo VECTTOR treatment for six months - The subjects receiving Active VECTTOR treatment averaged lower body muscle strength improved 131% while the subjects receiving Placebo VECTTOR treatment averaged lower body muscle strength only improved 53%. 


Measurements for lower body strength were taken as follows:

 

24 (12 per side) measurements were taken including Hip [Flexion, Extension (Knee Neutral), Abduction (Hip Neutral), Adduction, Internal Rotation, and External Rotation), Knee [Flexion (Leg Neutral) and Extension], Ankle [Plantar Flexion (Knee Neutral) and Dorsiflexion], and Foot (Inversion and Eversion).

 

The sum total of all measurements were averaged according to patient group (active or placebo). 

 

Data from Participant #6 was not included in this graph.

 

Average strength increase of the upper body extremities for those subjects receiving Active and Placebo VECTTOR treatment for six months - The subjects receiving Active VECTTOR treatment averaged upper body muscle strength improved 69% while the subjects receiving Placebo VECTTOR treatment averaged upper body muscle strength only improved 44%. 


Measurements for upper body strength were taken as follows:

 

20 (10 per side) measurements taken including Shoulder (Flexion, Extension, Abduction, Adduction, Internal Rotation, and External Rotation), Elbow [Flexion (Forearm neutral) and Extension], and Wrist (Flexion and Extension).

 

The sum total of all measurements were averaged according to patient group (active or placebo). 

 

Data from Participant #6 was not included in this graph.

 

Range of Motion

Averaged Results

 

Average range of motion increase of lower body extremities for those subjects receiving Active and Placebo VECTTOR treatments for six months -  The subjects receiving Active VECTTOR treatment averaged range of motion for lower body extremities improved 59% while the subjects receiving Placebo VECTTOR treatment averaged range of motion for lower body extremities only improved 33%. 


Measurements for lower body range of motion were taken as follows:

 

24 measurements were taken including Hip (Flexion, Extension, Abduction, Adduction, Internal Rotation, and External Rotation), Knee (Flexion and Extension), Ankle (Plantar Flexion and Dorsiflexion), and Foot (Inversion and Eversion).

 

The sum total of all measurements were averaged according to patient group (active or placebo). 

 

Data from Participant #6 was not included in this graph.

Average range of motion increase of upper body extremities for those subjects receiving Active and Placebo VECTTOR treatments for six months -  The subjects receiving Active VECTTOR treatment averaged range of motion for upper body extremities improved 75% while the subjects receiving Placebo VECTTOR treatment averaged range of motion for upper body extremities only improved 34%. 

 

Upper body Range of Motion Testing for each participant each time tested:

 

20 measurements taken including Shoulder (Flexion, Extension, Abduction, Adduction, Internal Rotation, and External Rotation), Elbow (Flexion and Extension), and Wrist (Flexion and Extension).

 

The sum total of all measurements were averaged according to patient group (active or placebo). 

 

Data from Participant #6 was not included in this graph.

Sleep Studies

Averaged Results

 

 

Averaged Arousal Statistics Index for those subjects receiving Active and Placebo VECTTOR treatment for six months.

 

The subjects receiving Active VECTTOR treatment averaged ASI improved 41% while the subjects receiving Placebo VECTTOR treatment averaged ASI worsened 52%.

 

The Arousal Statistics Index (ASI) is measured by the number of times sleep is interrupted per hour. Lower ASI values/numbers indicate improved sleep quality. (1)

 

 

Averaged percentage of REM sleep for those subjects receiving Active and Placebo VECTTOR treatment for six months - The subjects receiving Active VECTTOR treatment averaged percentage of REM sleep improved 23% while the subjects receiving Placebo VECTTOR treatment averaged percentage of REM sleep worsened 25%. 

 

Rapid-eye movement (REM) sleep allows the muscles in the body to relax. (2)

Averaged percentage of N3 Sleep (Slow Wave Sleep) for those subjects receiving Active and Placebo VECTTOR treatment for six months.

 

The subjects receiving Active VECTTOR treatment averaged percentage of Slow Wave Sleep improved 6%, while the subjects receiving Placebo VECTTOR treatment averaged percentage of Slow Wave Sleep worsened 24%. 

 

N3 Sleep, also known as Slow Wave Sleep (SWS), is the most restorative sleep stage. SWS is associated with decreased heart rate, blood pressure, and sympathetic nervous system activity. (3)

 


Subject #1 (Active)

17 Years Old 

No Steroids

Subject #1

Average lower body strength increase - 67% 

Subject #1

Average upper body strength increase - 63% 

Subject #1

Average lower body range of motion increase - 74%

Subject #1

Average upper body range of motion increase - 165%

 

Subject #1

Arousal Statistics Index - 12% Decline

Subject #1

Percentage of N3 (Slow Wave) Sleep improved 21%

Subject #1 - Percentage of Rapid Eye Movement (REM) Sleep improved 27%

Subject #2 (Active)

13 Years Old 

20 mg Predisone/day

*Decreased steroids from 20mg/day to 5mg/day during month 1 of study

Continued on Prednisone 5 mg/day for duration of the study 

Subject #2

Average lower body strength increase -  285% 

Subject #2

Average upper body strength increase - 82% 

Subject #2

Average lower body range of motion increase - 46%

Subject #2

Average upper body range of motion increase - 27%

Subject #2

Arousal Statistics Index - 73% Improvement

Subject #2

Percentage of N3 (Slow Wave) Sleep declined 4%

Subject #2

Percentage of Rapid Eye Movement (REM) Sleep improved 64%

Subject #3 (Active)

9 Years Old

No Steroids

Subject #3

Average lower body strength increase - 41% 

Subject #3

Average upper body strength increase - 35% 

Subject #3

Average lower body range of motion increase - 56%

Subject #3

Average upper body range of motion increase - 31%

Participant #3

Arousal Statistics Index - 47% Improvement

Subject #3

Percentage of N3 (Slow Wave) Sleep improved 44%

Subject #3

Percentage of Rapid Eye Movement (REM) Sleep improved 16%

Subject #4 (Placebo)

24mg Deflazacort/day

9 Years Old

Subject #4

Average lower body strength increase - 49%

Subject #4

Average upper body strength increase - 50% 


Subject #4

Average lower body range of motion increase  - 19%


Subject #4

Average upper body range of motion improvement - 17%

Subject #4

Arousal Statistics Index - 56% Decline 

Subject #4

Percentage of N3 (Slow Wave) Sleep decreased 27%

Subject #4

Percentage of Rapid Eye Movement (REM) Sleep Decreased 8%

Subject #5 (Placebo)

9 Years Old

Subject #5

Average lower body strength increase - 56%

Subject #5

Average upper body strength increase - 38% 

Subject #5

Average lower body range of motion increase - 47%

Subject #5

Average upper body range of motion increase - 50%

Subject #5 

Arousal Statistic Index - 52 % Decline

Subject #5

Percentage of N3 (Slow Wave) Sleep decreased 28%

Subject #3

Percentage of Rapid Eye Movement (REM) Sleep decreased 54%

 

 

Full and complete data from the trial can be viewed here:

 

https://clinicaltrials.gov/ct2/show/results/NCT01874275?term=vecttor&rank=1&sect=X490156


VECTTOR Therapy has been cleared by the US FDA for the treatment of chronic, intractable pain and for the treatment of post surgical/trauma pain. Any other use is considered “off label”.

 

 

Caution: There are contraindications, warnings, precautions, and guidelines that should be reviewed with your physician prior to using the

VECTTOR Therapy System

 

 

(1) Arousal Sleep Index (ASI) 


The ASI is measured by the number of times sleep is interrupted per hour.  Lower ASI values/numbers indicate improved sleep quality.

It has been demonstrated that sleep fragmentation is disruptive to the rejuvenating value of sleep and causes death at a younger age with cardiomyopathy. (Bianchi MT, Eiseman NA, Cash SS, Mietus J, Peng CK, Thomas RJ. “Probabilistic sleep architecture models in patients with and without sleep apnea.”  J Sleep Res. 2012 Jun;21(3):330-41. dli: 10.1111/j.1365-2869.2011.00937.x. Epub 2011 Sep 28.)    (Martino TA, Oudit GY, Herzenberg AM, Tata N, Koletar MM, Kabir GM, Belsham DD, Backx PH, Ralph MR, Sole MJ.  “Circadian rhythm disorganization produces profound cardiovascular and renal disease in hamsters.”  Am J Physiol Regul Integr Comp Physiol. 2008 May;294(5):R1675-83. doi: 10.1152/ajpregu.00829.2007. Epub 2008 Feb 13.

(2) Rapid Eye Movement (REM) sleep

Rapid-eye movement (REM)  sleep allows the muscles in the body to relax.  In boys with DMD REM sleep as a proportion of total sleep was significantly reduced, compared to normal values.  In addition, the duration of REM sleep was significantly lower in DMD patients using wheelchair (non-ambulatory) as compared to those who were not using wheelchair (ambulatory).   (Redding GJ, Okamoto GA, Guthrie RD, Rollevson D, Milstein JM.  “Sleep patterns in nonambulatory boys with Duchenne muscular dystrophy.”  Arch Phys Med Rehabil. 1985 Dec;66(12):818-21.)

 

(3) N3 Sleep

N3 Sleep also known as Slow Wave Sleep (SWS), is the most restorative sleep stage, is associated with decreased heart rate, blood pressure, and sympathetic nervous activity.  (Van Cauter E1, Spiegel K, Tasali E, Leproult R.  “Metabolic consequences of sleep and sleep loss.”  Sleep Med. 2008 Sep;9 Suppl 1:S23-8. doi: 10.1016/S1389-9457(08)70013-3.)