Neuromuscular Electrical Stimulation for Jaw-closing Dystonia
Phase: NA
Conditions: Muscle Dystonia
Sponsor: Edward Burton

Neuromuscular electrical stimulation for the treatment of jaw-closing dystonia 
 
 
NCT03889704 
STUDY18120054 
 
Edward A. Burton, MD, DPhil, FRCP 
University of Pittsburgh 
15 June 2021 
 
 
 

Study Title 
Neuromuscular electrical stimulation for the treatment of 
jaw-closing dystonia 
Study Design 
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 
oromandibular dystonia questionnaire (OMDQ-25) will be 
employed to determine whether there is any objective 
change in jaw opening or evidence of functional 
improvement. 
Primary Objective 
(1) Measure whether neuromuscular electrical stimulation 
increases inter-incisor (or inter-gum) distance in patients 
with jaw-closing dystonia as an objective measurement of 
jaw opening. 
(2) Assess whether neuromuscular electrical stimulation 
alters quality-of-life in patients with jaw-closing dystonia.  
 
Secondary Objective(s) 
(1) Determine effect size, variability and distribution of data 
to allow rational design of a larger study if the intervention 
looks promising. 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Omnistim® FX² 
IND/IDE #  
 
Study Population 
Adult male and female patients with jaw-closing dystonia 
Sample Size 
6 
Study Duration for 
individual participants 
8 weeks 
Study Specific 
Abbreviations/ 
Definitions  
NMES: neuromuscular electrical stimulation 
PNES: patterned electrical neuromuscular stimulation 
PD: Parkinson’s disease 
PSP: progressive supranuclear palsy 
AD: Alzheimer’s disease 
TDQ: tongue depressor quantity 
OMDQ-25: oromandibular dystonia questionnaire 
 
 
 
 

Objectives 
 
1. Measure whether neuromuscular electrical stimulation increases inter-incisor (or inter-
gum) distance in patients with jaw-closing dystonia as an objective measurement of jaw 
opening. 
2. Assess whether neuromuscular electrical stimulation alters quality-of-life in patients 
with jaw-closing dystonia.  
3. Determine effect size, variability and distribution of data to allow rational design of a 
larger study. 
 
Background 
This pilot study is designed to acquire initial data on whether neuromuscular electrical 
stimulation might be useful for the treatment of jaw-closing dystonia.   
 
Study design 
Open-label pilot study. 
 
Study Primary Endpoints 
1. Measure whether neuromuscular electrical stimulation increases inter-incisor (or inter-gum) 
distance in patients with jaw-closing dystonia as an objective measurement of jaw opening, both 
before and after each treatment session, and from baseline to the end of the study. 
 
2. Assess whether neuromuscular electrical stimulation alters quality-of-life in patients with 
jaw-closing dystonia by measuring change in OMDQ-25 from baseline to the end of the study 
 
Study Intervention/Investigational Agent 
Omnistim® FX² neuromuscular stimulation device, set to “muscle spasm reduction”.  The United 
States Food and Drug Administration has determined that the Omnistim® FX² device is 
substantially equivalent to other legally marketed predicate devices to be marketed within the 
provisions of the Federal Food, Drug, and Cosmetic Act.   
 
Procedures Involved 
6 patients will be enrolled in the study and written informed consent will be obtained at the 
beginning of the study prior to the first session.   
 
Each participant will participate in 16 sessions over the 8 weeks of the study.   
 
The electrodes will be placed over bilateral masseters using a bipolar technique; on each side, 
one electrode will be placed over the motor point, and one electrode will be placed over the 
belly of the muscle. The Omnistim® FX² device will be set to the “muscle spasm reduction” and 
electrical stimulation will last 20 minutes, during which time the patient will be directly 
supervised by the treating physician.  After completion of stimulation, electrodes will be 
removed, and the patient’s skin will be cleaned and examined for hyperemia and irritation.  At 

the end of each individual patient session, the equipment will be cleaned with germicidal 
wipes, including the control panel and lead wires. The electrodes are disposable and will be 
discarded after singe use.   
 
The severity of jaw-closing dystonia will be measured using 2 methods: 
 
1. Determine how many stacked tongue depressors the patient is able to fit safely between 
their front incisors (tongue depressor quantity, TDQ).  In the case of edentulous patients 
who are not able to wear their dentures because of dystonia, we will measure the 
distance between the front gums using the same method.   TDQ is a simple rapid 
measurement that is carried out routinely in speech therapy practice for evaluation and 
conservative treatment of jaw opening problems.  This will be measured before and after 
each treatment session. 
2. The impact of jaw-closing dystonia on the patient’s functional status will be determined 
using the oromandibular dystonia questionnaire (OMDQ-25), which has been shown to 
be both a valid tool to assess quality-of-life in oromandibular dystonia and sensitive to 
change after botulinum toxin treatment (Merz et al. 2010). OMDQ-25 will be evaluated 
at baseline and after each treatment session.  
 
Data and Specimen Banking 
All data will be de-identified, with each participant being assigned a study number, and all 
study documents aside from consent forms will be labeled only with this identifier.  De-
identified data will be digitized for analysis and stored on a UPMC server in a password-
protected user account.  There will be no specimen banking. 
 
Sharing of Results with Subjects 
Results will be shared with the subjects upon completion of the study. 
 
Study Timelines 
Each patient will undergo 16 sessions total, for a total of 8 consecutive weeks (or fewer sessions 
if individual patients experience discomfort or other problems).   
 
Inclusion criteria: 
1. Jaw-closing dystonia, which may be primary or secondary to a neurodegenerative 
disease or medications.  
2. Unable to voluntarily open jaw fully on examination. 
3. 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.  
4. Patient interested in participating, and willing to attend multiple treatment sessions in 
the neurology clinic. 
 
 

Exclusion criteria: 
1. Presence of a cardiac pacemaker, implanted defibrillator, or other implanted electronic 
device 
2. Inability to provide consent (either by the patient, spouse or an identified power of 
attorney) 
3. Age 18 years or younger 
4. Pregnancy 
 
Vulnerable Populations 
Our study population potentially includes adults with neurodegenerative diseases who may 
also have cognitive impairment.  In the case of severe cognitive impairment that precludes the 
patient giving bona fide informed consent, this will be given instead by the patient’s power of 
attorney (POA), spouse, or adult son or daughter.  In this case, treatment will only be carried 
out with the patient’s clear and unequivocal assent.  If no POA, spouse, or child is identified, 
then the patient will be excluded from the study.  
 
Local Number of Subjects 
6 patients will be recruited in total for this pilot study. 
 
Withdrawal of Subjects 
Patients will be withdrawn from the study if they experience hyperemia at the electrode 
placement sites that does not resolve between patient sessions, or if they experience more than 
mild discomfort that requires complete termination of neurostimulation at any point during the 
course of the study. Patients will also be withdrawn from the study if they experience muscle 
fatigue or weakness which interferes will daily functions like speaking or chewing food. 
Placement of a cardiac pacemaker, implanted defibrillator, or other implanted electronic device 
at any point during the study will also lead to withdrawal. 
 
Risks to Subjects 
Prior work using NMES to treat oropharyngeal dysphagia suggests that adverse events can 
include a burning sensation during treatment, skin irritation and soreness at the electrode site, 
neck pain, jaw pain, and headache. 
 
Potential Benefits to Subjects 
Patients may experience functional improvement in activities impaired by jaw-closing dystonia, 
including speaking, chewing, mouth opening for oral hygiene, comfort, eating, drinking.   
 
Data Management and Confidentiality 
All data collected will be stored in a locked office room and de-identified, with each participant 
being assigned a study number, and all study documents aside from consent forms will be 
labeled only with this identifier.  A single hard copy key document will relate each participant’s 
identity to their study number.  De-identified data will be digitized for analysis and stored on a 
server in a password-protected user account.  

Provisions to Monitor the Data to Ensure the Safety of Subjects 
A data and safety monitoring plan will include quarterly meetings to discuss issues regarding 
enrollment, status of the visits, recruitment, data coding and entry and/or address any adverse 
events, issues or concerns at that time.  
 
Provisions to Protect the Privacy Interests of Subjects 
Research data will be de-identified using a subject number.  The only patient identifiable data 
will be the consent form and the ‘key’ list relating the participant number to their name, both of 
which will be stored in a locked filing cabinets in a locked office.  Data digitized for analysis 
will be de-identified and stored in password-protected files on servers in password-protected 
accounts. 
 
Economic Burden to Subjects 
Patients will be given a voucher for free parking to attend study visits.