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Impact of Direct Current Electrical Stimulation on Spasticity Levels and Functional Muscle Use in MS

CompletedNA

Sponsor: CommonSpirit Health

Conditions: Multiple Sclerosis

Interventions: Neubie

Countries: United States

In an individual with MS the central nervous system (CNS) is over-protective and causes the threshold for stretch reflex and muscle tightness to be set lower than normal. This inhibits normal movement and causes abnormalities in posture, stiffness and at times joint contractures. In this pilot study we hope to assess the ability for the direct current of Neubie, which creates mechanoreceptor inputs and lengthening at the sarcomere level of muscle and joints in the spine and lower extremity, to alter the proprioceptive peripheral nervous system (PNS) at muscle spindle and GTO level with a change in CNS over-guarding during the treatment and after the treatment. If the investigators are able to create normalized stretch and muscle tension at the PNS level, it may be possible to create temporary or sustained CNS level changes. This would allow the amount of stretch and tension at the PNS level to be normalized and possibly reduce spasticity. If this theory is accurate, the investigators may be able to increase access to normalized movement, strength and functional ability in individuals with neuro-compromise.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Greater than 18 years old (no upper age limit)
2. Physician diagnosed MS (As stated in Rooney S, et al. Disabil Rehabil. 2019, stage of MS did not impact individuals from making neuromuscular or functional gains. All stages of MS will be eligible)
3. Physician clearance to participate
4. Unable to ambulate more than 70 feet at a time and unable to ambulate outside the home, with use of manual chair or power chair as mobility source \>= 50% of the time.
5. BLE MMT in hips, knees and ankles \<=3/5
6. Modified Ashworth assessed spasticity levels 1-4

Exclusion Criteria:

1. Co-morbidities in cardiovascular disease (myocardial infarction in past 1-year, unstable angina, CHF, h/o arrythmia, h/o CVA or TIA in past year, uncontrolled hypertension)
2. History of epileptic seizures
3. Lower Motor Neuron disease
4. Existing pacemaker, defibrillator or other implanted device (other than baclofen pump)
5. Unstable long bone fractures of lower limb or trunk
6. Allergies to surface electrodes or conductive gel
7. Pregnancy or actively seeking to become pregnant

Locations (1)

Littleton, Colorado, United States