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Neuromuscular Electrical Stimulation for Jaw-closing Dystonia

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ClinicalTrials.gov Identifier: NCT03889704
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Edward Burton, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Muscle Dystonia Device: Omnistim® FX² Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neuromuscular Electrical Stimulation for Jaw-closing Dystonia
Estimated Study Start Date : May 16, 2019
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889704


Contacts
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Contact: Cameron Miller-Patterson, MD 412-692-2527 millerpatterson@gmail.com

Locations
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United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Cameron Miller-Patterson, MD         
Sponsors and Collaborators
Edward Burton
Investigators
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Principal Investigator: Edward Burton, MD, DPhil University of Pittsburgh

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Responsible Party: Edward Burton, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03889704     History of Changes
Other Study ID Numbers: STUDY18120054
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases