Neuromuscular Electrical Stimulation for Jaw-closing Dystonia

Study Overview
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Brief Summary
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6 patients with jaw-closing dystonia will be treated with neuromuscular electrical stimulation over 8 weeks. The distance the mouth can be opened voluntarily and the oro-mandibular dystonia questionnaire (OMDQ-25) will be employed to determine whether there is any objective change in jaw opening or evidence of functional improvement.

Official Title
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Neuromuscular Electrical Stimulation for Jaw-closing Dystonia

Conditions
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Muscle Dystonia

Intervention / Treatment
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* Device: Omnistim® FX²


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Jaw-closing dystonia, which may be primary or secondary to a neurodegenerative disease or medications. Unable to voluntarily open jaw fully on examination. Evidence of functional impairment resulting from dystonia including inability to completely open the jaw during speaking or eating to such an extent that it interferes with these tasks. Patient interested in participating, and willing to attend multiple treatment sessions in the neurology clinic. Exclusion Criteria: Presence of a cardiac pacemaker, implanted defibrillator, or other implanted electronic device. Inability to provide consent (either by the patient, spouse, or an identified power of attorney). Age under 18 years. Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuromuscular electrical stimulation<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jaw Opening | 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. | Change from before starting first treatment to after completing last treatment, usually completed over 8 weeks. | 
| Jaw Opening | 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. | Average change from before to after each 20-minute treatment session. | 
| Oromandibular Dystonia Questionnaire | 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. | Change from before the first treatment to after the last treatment, usually over 8 weeks. |