Trial Outcomes & Findings for Neuromuscular Electrical Stimulation for Jaw-closing Dystonia (NCT NCT03889704)
NCT ID: NCT03889704
Last Updated: 2021-07-09
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
Change from before starting first treatment to after completing last treatment, usually completed over 8 weeks.
Results posted on
2021-07-09
Participant Flow
Participant milestones
| Measure |
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.
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.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
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.
|
|---|---|
|
Overall Study
Study terminated due to pandemic
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Neuromuscular Electrical Stimulation
n=2 Participants
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.
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.
|
|---|---|
|
Age, Continuous
|
72 years
n=2 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=2 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=2 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Neuromuscular Electrical Stimulation
n=2 Participants
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.
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.
|
|---|---|
|
Jaw Opening
|
3 tongue depressors
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Neuromuscular Electrical Stimulation
n=2 Participants
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.
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.
|
|---|---|
|
Jaw Opening
|
0.0813 Tongue depressors
Interval 0.0625 to 0.1
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Neuromuscular Electrical Stimulation
n=2 Participants
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.
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.
|
|---|---|
|
Oromandibular Dystonia Questionnaire
|
-21 score on a scale (OMDQ25)
Interval -29.0 to -13.0
|
Adverse Events
Neuromuscular Electrical Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place