Neuromuscular Electrical Stimulation for Jaw-closing Dystonia

NCT03889704 | Terminated Results FDA Device

• 1 other identifier: STUDY18120054
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Dystonia

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (1)

Neuromuscular electrical stimulation

EXPERIMENTAL

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

Interventions

Omnistim® FX² DEVICE

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.

Neuromuscular electrical stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edward Burton: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Dystonia

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Owing to pandemic restrictions, the study only recruited 2 patients prior to termination and only 1 completed all sessions.

Results Point of Contact

• Title: Dr. Edward Burton
• Organization: University of Pittsburgh

eab25@pitt.edu

4126924670

Study Officials

• Edward Burton, MD, DPhil

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 26, 2019
• Study Start: May 16, 2019
• Primary Completion: July 1, 2020
• Study Completion: February 3, 2021
• Last Updated: July 9, 2021
• Results First Posted: July 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)