Muscle DystoniaNCT03889704
Neuromuscular Electrical Stimulation for Jaw-closing Dystonia
A study testing Omnistim® FX² in people with Muscle Dystonia, run by Edward Burton at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Dystonia
- What is being tested?
- Omnistim® FX²
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2019to 3 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
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.
- Conditions
- Muscle Dystonia
- Being tested
- Omnistim® FX²
- Medical subject headings
- Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnistim® FX²Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular electrical stimulation | Experimental | 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. Receives: Device: Omnistim® FX² |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from before the first treatment to after the last treatment, usually over 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start16 May 2019
- Primary completion1 Jul 2020
- Study completion3 Feb 2021
Why it stopped: Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Muscle DystoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Burton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edward Burton, University of Pittsburgh
- Investigators
- Edward Burton, MD, DPhil, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889704
- Sponsor's protocol ID
- STUDY18120054
- Status last verified
- Jun 2021
- First submitted
- 19 Mar 2019
- Last updated
- 9 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation for Jaw-closing Dystonia
- ClinicalTrials.gov ID
- NCT03889704
- Acronym / sponsor ID
- STUDY18120054
- Conditions
- Muscle Dystonia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pandemic
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Edward BurtonUniversity, hospital or other
- Study start
- 16 May 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 3 Feb 2021 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Posted 9 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular electrical stimulation | Experimental | Device: Omnistim® FX²The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omnistim® FX²The 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. | Device | Neuromuscular electrical stimulation |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Burton, MD, DPhil principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omnistim® FX² in people with Muscle Dystonia, run by Edward Burton at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jaw Opening (time frame: Change from before starting first treatment to after completing last treatment, usually completed over 8 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.