Back to resultsNeuromuscular Electrical Stimulation for Jaw-closing Dystonia
Primary Purpose
Muscle Dystonia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omnistim® FX²
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Dystonia
Eligibility Criteria
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.
Sites / Locations
- University of Pittsburgh Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neuromuscular electrical stimulation
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03889704
Brief Title
Neuromuscular Electrical Stimulation for Jaw-closing Dystonia
Official Title
Neuromuscular Electrical Stimulation for Jaw-closing Dystonia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Pandemic
Study Start Date
May 16, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
February 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Edward Burton
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Dystonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neuromuscular electrical stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Omnistim® FX²
Intervention Description
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.
Primary Outcome Measure Information:
Title
Jaw Opening
Description
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.
Title
Jaw Opening
Description
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.
Title
Oromandibular Dystonia Questionnaire
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Burton, MD, DPhil
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neuromuscular Electrical Stimulation for Jaw-closing Dystonia
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