Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The project was not funded.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
| Colorado State University | OTHER |
Not provided
Not provided
Not provided
Not provided
The objective of the clinical trial is to quantify the capacity of a translatable protocol of electrical nerve stimulation (TENS) to improve walking performance and self-reported disabilities of persons with MS. The hypothesis is that activation of sensory nerve fibers with augmented TENS promotes recovery of sensorimotor function and improves the disability status of individuals with MS. The rationale for the proposed clinical trial is that the approach provides a low-cost therapeutic strategy for persons with MS to manage walking limitations and fatigue.
The study will involve a randomized, double-blind, controlled trial. Randomization will be accomplished by recruiting two individuals with a similar level of disability at a time and flipping a coin (two persons present) to determine the group assignment (A or B) of the person who contacted the investigators first. The participants and outcome assessors will be blinded to group assignment. Both groups will receive the treatment (real or sham) during the first 4 weeks (3 sessions/week)and then there will be an 8-week follow-up period. Participants will be evaluated at weeks 0, 4, 8, and 12.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Augmented TENS | Experimental | Transcutaneous electrical nerve stimulation applied to each leg separately while participants perform steady submaximal contractions. |
|
| Sham | Sham Comparator | Transient (10 s) application of transcutaneous electrical nerve stimulation applied to each leg separately while participants perform steady submaximal contractions . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous electrical nerve stimulation | Device | Commercially available device will be used to apply weak electrical currents to arm and leg muscles in each of 18 treatment sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gait Speed | Time to walk 25 ft as quickly as possible | Change from baseline at weeks 4, 8, and 12. |
| Change in Walking Endurance | Distance walked in 6 min when walking at a brisk pace | Change from baseline at weeks 4, 8, and 12 |
| Change in Dynamic Balance | Score achieved on the four components of the 14-item Mini-Balance Evaluation Systems Test (Mini-BESTest). The maximum score for each subscale are: anticipatory = 6, reactive postural control = 6, sensory orientation = 6, dynamic gait = 10. The subscales are added to provide a total score with a maximum of 28. | Change from baseline at weeks 4, 8, and 12 |
| Change in Patient Determined Disease Steps | A questionnaire with a self-assessment scale of disease status. The scores range from 0 = normal to 8 = bedridden. | Change from baseline at weeks 4, 8, and 12 |
| Change in Modified Fatigue Impact Scale | A questionnaire that assesses the impact of fatigue experienced by persons with MS. Each of the 21 items is rated from 0 = Never to 5 = Almost always. The maximum total score = 105 | Change from baseline at weeks 4, 8, and 12. |
| Change in MS Walking Scale-12 | A 12-item, patient-rated measure of how much MS compromises walking ability. Each item is rated from 1 = Not at all to 5 = extremely. The maximum total score = 60. | Change from baseline at weeks 4, 8, and 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Romberg Quotient | Ratio of the total sway area when standing with the eyes closed relative to that when the eyes are open. The test will be performed while standing on a firm surface and a foam surface. | Change from baseline at weeks 4, 8, and 12. |
| Change Conditioned H-reflex Amplitude |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Roger Enoka, PhD | University of Colorado, Denver | Principal Investigator |
Not provided
There is no plan to share the data obtained by individual participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Comparison of the percent reduction in the amplitude of the conditioned H-reflex amplitude in soleus while seated, standing with eyes open, and standing with eyes closed. |
| Change from baseline at weeks 4, 8, and 12. |
| Change in Proprioception Tract | Change in MRI signal intensity in corticospinal tract | Change from baseline at weeks 4, 8, and 12. |
| Change in Muscle Synergy Number | Non-negative matrix factorization will be used to identify the number of muscle synergies when subjects walk on a treadmill. | Change from baseline at weeks 4, 8, and 12 |
| Change in Force Steadiness | The coefficient of variation for force when subjects perform steady, submaximal contractions. | Change from baseline at weeks 4, 8, and 12. |
| Change in Muscle Synergy TIming | The timing of the muscle synergies when subjects walk on a treadmill. | Change from baseline at weeks 4, 8, and 12. |
| Change in Discharge characteristics | The mean and coefficient of variation for the times between action potentials during steady isometric contractions. | Change from baseline at weeks 4, 8, and 12. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |