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| ID | Type | Description | Link |
|---|---|---|---|
| R03HD079508 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The purpose of this study is to investigate the capacity of a 6-week treatment with neuromuscular electrical stimulation to improve walking in individuals whose mobility has been compromised by multiple sclerosis.
Participants will be randomly assigned to one of two study arms. Those in one arm will receive a treatment with narrow stimulus pulses (0.4 ms) and those in the other arm will receive wide stimulus pulses (1 ms). The electrical stimulation will be delivered with a Vectra Genisys System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Narrow pulse | Experimental | Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms. |
|
| Wide pulse | Experimental | Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Narrow pulse | Device | Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises narrow (0.4 ms) stimulus pulses. |
| Measure | Description | Time Frame |
|---|---|---|
| Walking Endurance | Distance walked in 6 min | Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week). |
| Modified Fatigue Impact Scale | MFIS scores range from 0 to 84 and higher numbers indicating worse fatigue. | Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Walking Speed | The time it takes to walk 25 ft | Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger Enoka, PhD | University of Colorado, Boulder | Principal Investigator |
| Jeffrey Hebert, PhD, PT | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Boulder | Colorado | 80309 | United States |
Three potential participants did not meet eligibility requirements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Narrow Pulse | Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms. Narrow pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises narrow (0.4 ms) stimulus pulses. |
| FG001 | Wide Pulse | Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms. Wide pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises wide (1 ms) stimulus pulses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Narrow Pulse | Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms. Narrow pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises narrow (0.4 ms) stimulus pulses. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Walking Endurance | Distance walked in 6 min | Posted | Mean | Standard Deviation | meters | Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week). |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Narrow Pulse | Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 0.4 ms. Narrow pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises narrow (0.4 ms) stimulus pulses. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roger Enoka | University of Colorado Boulder | 3034927232 | enoka@colorado.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 12, 2021 | Jan 12, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Wide pulse | Device | Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises wide (1 ms) stimulus pulses. |
|
| Wide Pulse |
Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms. Wide pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises wide (1 ms) stimulus pulses. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Modified Fatigue Impact Scale | MFIS scores range from 0 to 84 and higher numbers indicating worse fatigue. | Posted | Mean | Standard Deviation | score on a scale | Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week). |
|
|
|
| Secondary | Maximal Walking Speed | The time it takes to walk 25 ft | Posted | Mean | Standard Deviation | seconds | Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week). |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Wide Pulse | Six-week treatment of electrical stimulation applied to the calf muscles with stimulus pulses that last 1 ms. Wide pulse: Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises wide (1 ms) stimulus pulses. | 0 | 14 | 0 | 14 | 0 | 14 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |