Neuromuscular Electrical Stimulation for Jaw-closing Dystonia

Edward Burton

Status: Terminated

Conditions: Muscle Dystonia

Treatments: Device: Omnistim® FX²

Study type: Interventional

Funder types: Other

Identifiers

NCT03889704

STUDY18120054

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Neuromuscular electrical stimulation

Experimental group

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.

Treatment:

Device: Omnistim® FX²