Muscle Dystonia
Conditions
Brief summary
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.
Interventions
DEVICEOmnistim® 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.
Sponsors
Edward Burton
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Jaw Opening | 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. |
| Oromandibular Dystonia Questionnaire | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study terminated due to pandemic | 1 |
Baseline characteristics
| Characteristic | Neuromuscular Electrical Stimulation | — |
|---|---|---|
| Age, Continuous | 72 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 2 participants | — |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
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.
Time frame: Change from before starting first treatment to after completing last treatment, usually completed over 8 weeks.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Neuromuscular Electrical Stimulation | Jaw Opening | 3 tongue depressors |
Primary
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.
Time frame: Average change from before to after each 20-minute treatment session.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Neuromuscular Electrical Stimulation | Jaw Opening | 0.0813 Tongue depressors |
Primary
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.
Time frame: Change from before the first treatment to after the last treatment, usually over 8 weeks.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Neuromuscular Electrical Stimulation | Oromandibular Dystonia Questionnaire | -21 score on a scale (OMDQ25) |