Neuromuscular Electrical Stimulation for Jaw-closing Dystonia

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 Overview

• Status: Terminated
• Conditions: Muscle Dystonia
• Intervention / Treatment: Device: Omnistim® FX²

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Edward Burton
• Investigators: Principal Investigator: Edward Burton, MD, DPhil, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2019
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): February 3, 2021

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Dystonia; Dystonic Disorders
• Other Study ID Numbers: STUDY18120054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes