Neuromuscular Electrical Stimulation for Jaw-closing Dystonia
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|ClinicalTrials.gov Identifier: NCT03889704|
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : May 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Muscle Dystonia||Device: Omnistim® FX²||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neuromuscular Electrical Stimulation for Jaw-closing Dystonia|
|Estimated Study Start Date :||May 16, 2019|
|Estimated Primary Completion Date :||December 15, 2019|
|Estimated Study Completion Date :||February 1, 2020|
Experimental: Neuromuscular electrical stimulation
The Omnistim® FX² is a neuromuscular stimulation device that provides patterned electrical neuromuscular stimulation (PENS) via cutaneous electrodes placed over relevant musculature. It will be applied for 20 minutes per session. For each patient, there will be 2 sessions per week, spaced 3 to 4 days apart. Each patient will participate in 16 sessions over the 8 weeks of the study. There will be 6 patients total.
Device: Omnistim® FX²
The Omnistim® FX² is a neuromuscular stimulation device that provides patterned electrical neuromuscular stimulation (PENS) via cutaneous electrodes placed over relevant musculature. The device mimics physiologic patterns of neuron firing.
- Jaw opening [ Time Frame: Change from before starting first treatment to after completing last treatment, usually completed over 8 weeks. ]Measured via tongue depressor quantity, which is the number of stacked tongue depressors the patient is able to safely fit between his or her incisors.
- Jaw opening [ Time Frame: Average change from before to after each 20-minute treatment session. ]Measured via tongue depressor quantity, which is the number of stacked tongue depressors the patient is able to safely fit between his or her incisors.
- Oromandibular dystonia questionnaire [ Time Frame: Change from before the first treatment to after the last treatment, usually over 8 weeks. ]Questionnaire that assesses quality of life in oromandibular dystonia patients. There are 25 questions total, and each question may be answered as never, seldom, sometimes, often, always. Minimum score is 0, maximum score is 100. A higher score indicates worse quality of life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889704
|Contact: Cameron Miller-Patterson, MDemail@example.com|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Cameron Miller-Patterson, MD|
|Principal Investigator:||Edward Burton, MD, DPhil||University of Pittsburgh|