Trial Outcomes & Findings for Transcutaneous Electrical Stimulation for Spasticity in Patients With Primary Lateral Sclerosis (NCT NCT06012110)
NCT ID: NCT06012110
Last Updated: 2026-08-25
Results Overview
The Modified Ashworth Scale (MAS) is an ordinal scale that ranges from 0 (no increase in muscle tone) to 4 (rigid flexion or extension). Ten muscle groups were assessed bilaterally from 0-4 yielding a possible score of 0-80 where higher values reflect more rigid muscles indicating a worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
Baseline (immediately pre-intervention) and immediately post-intervention (within 30 minutes of intervention).
Results posted on
2026-08-25
Participant Flow
Participants were recruited as a convenience sample from a university based ALS clinic or via clinicaltrials.gov
Participant milestones
| Measure |
tSCS Intervention
Transcutaneous spinal cord stimulation (tSCS): While participants were supine with a pillow placed below the knees for comfort, they received one 30-minute tSCS session at a frequency of 50 Hz, pulse width of 400 microseconds and individualized amplitude.
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Overall Study
STARTED
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6
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Overall Study
COMPLETED
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6
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
tSCS Intervention
n=6 Participants
Primary lateral sclerosis (PLS) is a progressive upper motor neuron neurodegenerative disorder. A hallmark of PLS is a presentation with lower extremity stiffness and spasticity as well as bulbar involvement. The investigators performed a preliminary study designed to assess transcutaneous spinal cord stimulation (tSCS), a non-pharmacological and non-invasive modality used in spinal cord injury and multiple sclerosis patients, as a treatment for reducing spasticity in the lower extremities and increasing mobility in patients with PLS.
tSCS: While participants are supine with a pillow placed below the knees for comfort, one 30-minute transcutaneous electrical stimulation session will be performed at a frequency of 50 Hz, pulse width of 400 microseconds and individualized amplitude will be completed.
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Age, Continuous
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66 years
STANDARD_DEVIATION 8.17 • n=6 Participants
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Sex: Female, Male
Female
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3 Participants
n=6 Participants
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Sex: Female, Male
Male
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3 Participants
n=6 Participants
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Region of Enrollment
United States
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6 Participants
n=6 Participants
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Height
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69.17 Inches
STANDARD_DEVIATION 3.19 • n=6 Participants
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Weight
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165.5 Pounds
STANDARD_DEVIATION 24 • n=6 Participants
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Time since symptom onset (years)
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18.83 years
STANDARD_DEVIATION 7.00 • n=6 Participants
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PRIMARY outcome
Timeframe: Baseline (immediately pre-intervention) and immediately post-intervention (within 30 minutes of intervention).The Modified Ashworth Scale (MAS) is an ordinal scale that ranges from 0 (no increase in muscle tone) to 4 (rigid flexion or extension). Ten muscle groups were assessed bilaterally from 0-4 yielding a possible score of 0-80 where higher values reflect more rigid muscles indicating a worse outcome.
Outcome measures
| Measure |
tSCS Intervention
n=6 Participants
Primary lateral sclerosis (PLS) is a progressive upper motor neuron neurodegenerative disorder. A hallmark of PLS is a presentation with lower extremity stiffness and spasticity as well as bulbar involvement. The investigators will be performing a preliminary study designed to assess transcutaneous electrical stimulation (tES), a non-pharmacological and non-invasive modality used in spinal cord injury and multiple sclerosis patients, as a treatment for reducing spasticity in the lower extremities and increasing mobility in patients with PLS.
Transcutaneous electrical stimulation: While participants are supine with a pillow placed below the knees for comfort, one 30-minute transcutaneous electrical stimulation session will be performed at a frequency of 50 Hz, pulse width of 400 microseconds and individualized amplitude will be completed.
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Modified Ashworth Scale
Baseline, immediately pre-intervention
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29.6 MAS Points
Standard Deviation 20.4
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Modified Ashworth Scale
Immediately Post-intervention
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20.3 MAS Points
Standard Deviation 18.2
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SECONDARY outcome
Timeframe: Baseline (immediately pre-intervention) and immediately post-intervention (within 30 minutes of intervention).5 point ordinal scale recorded as a number from 0-4 where 2 is normal and any number above or below this is abnormal. The DTR scale was utilized on each participant and assessed bilaterally utilizing the Patellar and Achilles tendons with a total possible score of 0 to 16.
Outcome measures
| Measure |
tSCS Intervention
n=6 Participants
Primary lateral sclerosis (PLS) is a progressive upper motor neuron neurodegenerative disorder. A hallmark of PLS is a presentation with lower extremity stiffness and spasticity as well as bulbar involvement. The investigators will be performing a preliminary study designed to assess transcutaneous electrical stimulation (tES), a non-pharmacological and non-invasive modality used in spinal cord injury and multiple sclerosis patients, as a treatment for reducing spasticity in the lower extremities and increasing mobility in patients with PLS.
Transcutaneous electrical stimulation: While participants are supine with a pillow placed below the knees for comfort, one 30-minute transcutaneous electrical stimulation session will be performed at a frequency of 50 Hz, pulse width of 400 microseconds and individualized amplitude will be completed.
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Deep Tendon Reflex Scale
Baseline, immediately pre-intervention
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10.5 DTR Score Bilateral
Standard Deviation 4.0
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Deep Tendon Reflex Scale
Immediately post-intervention
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9.0 DTR Score Bilateral
Standard Deviation 5.5
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SECONDARY outcome
Timeframe: Baseline (immediately pre-intervention) and immediately post-intervention (within 30 minutes of intervention).The 10MWT measures gait speed where the time it takes patient to cover a distance of 6 meters is recorded in m/s.
Outcome measures
| Measure |
tSCS Intervention
n=6 Participants
Primary lateral sclerosis (PLS) is a progressive upper motor neuron neurodegenerative disorder. A hallmark of PLS is a presentation with lower extremity stiffness and spasticity as well as bulbar involvement. The investigators will be performing a preliminary study designed to assess transcutaneous electrical stimulation (tES), a non-pharmacological and non-invasive modality used in spinal cord injury and multiple sclerosis patients, as a treatment for reducing spasticity in the lower extremities and increasing mobility in patients with PLS.
Transcutaneous electrical stimulation: While participants are supine with a pillow placed below the knees for comfort, one 30-minute transcutaneous electrical stimulation session will be performed at a frequency of 50 Hz, pulse width of 400 microseconds and individualized amplitude will be completed.
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10-meter Walk Test (10MWT)
Baseline, immediately pre-intervention
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0.50 m/s
Standard Deviation 0.24
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10-meter Walk Test (10MWT)
Immediately post-intervention
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0.53 m/s
Standard Deviation 0.22
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SECONDARY outcome
Timeframe: Baseline (immediately pre-intervention) and immediately post-intervention (within 30 minutes of intervention).The 6MWT assesses overall gait function and endurance. The total distance travelled in 6 minutes is recorded in feet.
Outcome measures
| Measure |
tSCS Intervention
n=6 Participants
Primary lateral sclerosis (PLS) is a progressive upper motor neuron neurodegenerative disorder. A hallmark of PLS is a presentation with lower extremity stiffness and spasticity as well as bulbar involvement. The investigators will be performing a preliminary study designed to assess transcutaneous electrical stimulation (tES), a non-pharmacological and non-invasive modality used in spinal cord injury and multiple sclerosis patients, as a treatment for reducing spasticity in the lower extremities and increasing mobility in patients with PLS.
Transcutaneous electrical stimulation: While participants are supine with a pillow placed below the knees for comfort, one 30-minute transcutaneous electrical stimulation session will be performed at a frequency of 50 Hz, pulse width of 400 microseconds and individualized amplitude will be completed.
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6 Minute Walk Test (6MWT)
Baseline, immediately pre-intervention
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556.7 feet
Standard Deviation 229.2
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6 Minute Walk Test (6MWT)
Immediately post-intervention
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611.1 feet
Standard Deviation 243.5
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SECONDARY outcome
Timeframe: Baseline (immediately pre-intervention) and immediately post-intervention (within 30 minutes of intervention).3 point ordinal scale that ranges from 0-2 with a total possible score of 28 that measures gait quality and balance. Higher scores indicate improved gait and balance. Range is 0-28 points.
Outcome measures
| Measure |
tSCS Intervention
n=6 Participants
Primary lateral sclerosis (PLS) is a progressive upper motor neuron neurodegenerative disorder. A hallmark of PLS is a presentation with lower extremity stiffness and spasticity as well as bulbar involvement. The investigators will be performing a preliminary study designed to assess transcutaneous electrical stimulation (tES), a non-pharmacological and non-invasive modality used in spinal cord injury and multiple sclerosis patients, as a treatment for reducing spasticity in the lower extremities and increasing mobility in patients with PLS.
Transcutaneous electrical stimulation: While participants are supine with a pillow placed below the knees for comfort, one 30-minute transcutaneous electrical stimulation session will be performed at a frequency of 50 Hz, pulse width of 400 microseconds and individualized amplitude will be completed.
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Tinetti Performance Oriented Mobility Assessment
Baseline, immediately pre-intervention
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11.2 POMA Total Score
Standard Deviation 2.6
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Tinetti Performance Oriented Mobility Assessment
Immediately post-intervention
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13.8 POMA Total Score
Standard Deviation 3.2
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SECONDARY outcome
Timeframe: Baseline (immediately pre-intervention) and immediately post-intervention (within 30 minutes of intervention) and 24-hours post-interventionPatients will self rate their spasticity on a scale of 0-10 with 0 = no spasticity and 10 = worst possible spasticity.
Outcome measures
| Measure |
tSCS Intervention
n=6 Participants
Primary lateral sclerosis (PLS) is a progressive upper motor neuron neurodegenerative disorder. A hallmark of PLS is a presentation with lower extremity stiffness and spasticity as well as bulbar involvement. The investigators will be performing a preliminary study designed to assess transcutaneous electrical stimulation (tES), a non-pharmacological and non-invasive modality used in spinal cord injury and multiple sclerosis patients, as a treatment for reducing spasticity in the lower extremities and increasing mobility in patients with PLS.
Transcutaneous electrical stimulation: While participants are supine with a pillow placed below the knees for comfort, one 30-minute transcutaneous electrical stimulation session will be performed at a frequency of 50 Hz, pulse width of 400 microseconds and individualized amplitude will be completed.
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0-10 Numeric Rating Scale
Baseline, immediately pre-intervention
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6.5 0-10 Scale score
Standard Deviation 3.3
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0-10 Numeric Rating Scale
Immediately post-intervention
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4.5 0-10 Scale score
Standard Deviation 3.3
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0-10 Numeric Rating Scale
24 hours post-intervention
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4.8 0-10 Scale score
Standard Deviation 3.7
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Adverse Events
Transcutaneous Electrical Stimulation to Reduce Spasticity in PLS
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
Dr. Kayla Chomko, Director of Rehabilitation
Nova Southeastern University
Phone: 954-817-5730
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place