Duchenne Muscular Dystrophy Clinical Trial (DMD)
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:
- increased muscle strength,
- increased range of joint motions and
- improved sleep parameters of ASI, N3 and REM.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Texas
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Houston, Texas, Estados Unidos, 77004
- Alan Neuromedical
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: VECTTOR
nerve stimulator treatment twice daily for duration of study - 365 days
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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.
Outros nomes:
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Comparador de Placebo: 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>
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percent Change in Range of Motion From Baseline to 180 Days
Prazo: Baseline to 180 days
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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.
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Baseline to 180 days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percent Change in Muscle Strength
Prazo: Baseline to 180 days
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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.
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Baseline to 180 days
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Percent Change in Percent Range of Motion From Baseline to 365 Days
Prazo: Baseline to 365 days
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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.
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Baseline to 365 days
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Percent Change in Muscle Strength
Prazo: 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.
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Baseline to 365 days
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percent Change in Sleep Quality Arousal Statistics Index (ASI) From Baseline to 180 Days
Prazo: Baseline to 180 days
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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.
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Baseline to 180 days
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Sleep Arousal Statistics Index at 365 Days
Prazo: Baseline to 365 days
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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.
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Baseline to 365 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Charlotte Stelly-Seitz, MD, Pediatric Physical Medicine and Rehabilitation Houston, Texas
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- VECTTOR DMD2012
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