Neuromuscular Electrical Stimulation for Jaw-closing Dystonia

Muscle Dystonia Clinical Trial

Official title:

Neuromuscular Electrical Stimulation for Jaw-closing Dystonia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03889704
• Other study ID #: STUDY18120054
• Status: Terminated
• Phase: N/A
• Start date: May 16, 2019
• Est. completion date: February 3, 2021

Study information

• Verified date: June 2021
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 functional improvement.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 3, 2021
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Muscle Dystonia

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Edward Burton

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.