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Duchenne Muscular Dystrophy Clinical Trial (DMD)

14. april 2015 oppdatert av: Alan Neuromedical Technologies, LLC

Double-blind, Randomized, Placebo-controlled Study of VECTTOR Treatment for Duchenne Muscular Dystrophy

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

6

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Texas
      • Houston, Texas, Forente stater, 77004
        • Alan Neuromedical

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

8 år til 20 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: VECTTOR
nerve stimulator treatment twice daily for duration of study - 365 days
Enhet: 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.

Andre navn:
  • electrical nerve stimulator
Placebo komparator: Device - sham
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>
Enhet: 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.

Andre navn:
  • electrical nerve stimulator

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent Change in Range of Motion From Baseline to 180 Days
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent Change in Muscle Strength
Tidsramme: Baseline to 180 days
Muscle strength testing (Wireless Tracker system) - All muscle strength 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 muscle strength. JTech computerized testing system determined the muscle strength by radio signals from a strain gauge measuring strength of the participant's muscles. 44 separate tests were performed for muscle strength for each participant at each time interval. Efficacy is defined as an increase in the strength measurement (pounds) from Baseline to 180 days.
Baseline to 180 days
Percent Change in Percent Range of Motion From Baseline to 365 Days
Tidsramme: Baseline to 365 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, 180 and 365 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 365 days. Efficacy is defined as an increase in range of motion.
Baseline to 365 days
Percent Change in Muscle Strength
Tidsramme: Baseline to 365 days
Muscle strength testing (Wireless Tracker system) - All muscle strength 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, 180 and 365 days to determine changes in muscle strength. JTech computerized testing system determined the muscle strength by radio signals from a strain gauge measuring strength of the participant's muscles. 44 separate tests were performed for muscle strength for each participant at each time interval. Efficacy is defined as an increase in the strength measurement (pounds) from Baseline to 365 days.
Baseline to 365 days

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent Change in Sleep Quality Arousal Statistics Index (ASI) From Baseline to 180 Days
Tidsramme: Baseline to 180 days
Sleep / Arousal Statistics Index (ASI) description: Sleep Studies were obtained twice before beginning the study. The second sleep study data was used as baseline. A follow up sleep study was obtained after 6 months (180 days) of Active or Placebo VECTTOR treatment. Sleep, breathing, arousal(s), and limb movements were scored manually according to guidelines of the American Academy of Sleep Medicine. The efficacy of the outcome measure of ASI is demonstrated by a percent improvement between Baseline and 180 days. The ASI is measured by the number of times sleep is interrupted per hour.
Baseline to 180 days
Sleep Arousal Statistics Index at 365 Days
Tidsramme: Baseline to 365 days
Sleep / Arousal Statistics Index (ASI) description: Sleep Studies were obtained twice before beginning the study. The second sleep study data was used as baseline. A follow up sleep study was obtained after 6 months (180 days) of Active or Placebo VECTTOR treatment. Sleep, breathing, arousal(s), and limb movements were scored manually according to guidelines of the American Academy of Sleep Medicine. The efficacy of the outcome measure of ASI is demonstrated by a decrease in the value between Baseline and 180 days. The ASI is measured by the number of times sleep is interrupted per hour. Lower ASI values/numbers indicate improved sleep quality.
Baseline to 365 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alan Neuromedical Technologies, LLC

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2013

Primær fullføring (Faktiske)

1. september 2014

Studiet fullført (Faktiske)

1. september 2014

Datoer for studieregistrering

Først innsendt

7. juni 2013

Først innsendt som oppfylte QC-kriteriene

10. juni 2013

Først lagt ut (Anslag)

11. juni 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

4. mai 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. april 2015

Sist bekreftet

1. april 2015

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • VECTTOR DMD2012

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