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Reducing Fatigue in People With Multiple Sclerosis by Treatment With TENS

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ClinicalTrials.gov Identifier: NCT05500963
Recruitment Status : Not yet recruiting
First Posted : August 15, 2022
Last Update Posted : August 15, 2022
Sponsor:
Information provided by (Responsible Party):
Roger Enoka, University of Colorado, Boulder

Brief Summary:
The objective of the randomized, sham-controlled trial will be to evaluate the effectiveness of treatment with transcutaneous electrical nerve stimulation (TENS) at reducing the level of fatigue experienced by people with MS.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: Transcutaneous electrical nerve stimulation Not Applicable

Detailed Description:

We will compare the changes in self-reported levels of fatigue (symptom intensity) and measures of fatigability (work capacity) from before to after a 6-week intervention. Participants (18-65 yrs) will be randomly assigned to one of two groups: one group will receive an effective dose of TENS and the other group (control) will be given a sham dose of TENS. The treatment will be applied during 18 sessions (3x/week for 6 weeks) and delivered through electrodes placed on the skin overlying the dorsiflexor (tibialis anterior) and hip flexor (rectus femoris) muscles of both legs. Participants will be evaluated before (Week 0), during (Week 4), and after (Weeks 7 and 11) the 6-week intervention.

Our long-term goal is to develop strategies that can reduce the impact of fatigue on the daily activities of persons with MS. The objective of the randomized, sham-controlled trial will be to evaluate the effectiveness of treatment with TENS at reducing the level of fatigue experienced by people with MS. Our central hypothesis is that treatment with TENS applied to selected leg muscles in people with MS will produce superior improvements in self-reported and measured levels of fatigue and fatigability compared with a sham dose of TENS.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Fatigue in People With Multiple Sclerosis by Treatment With Transcutaneous Electrical Nerve Stimulation
Estimated Study Start Date : April 2023
Estimated Primary Completion Date : March 2027
Estimated Study Completion Date : March 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Effective dose
• The effective dose of TENS will be set at an intensity to elicit slight contractions in each target muscle, as we have done previously. It will be delivered as 5-Hz bursts (7 pulses at 100 Hz/burst) and applied during the light exercises. The applied current (<20 mA) will differ slightly for each of the four muscle groups and will be determined while the person is standing. The current will be set at the beginning of every treatment session for both groups of participants.
Device: Transcutaneous electrical nerve stimulation
Electrical stimulation applied over selected leg muscle will activate sensory receptors that will transmit signals back into the central nervous system.

Sham Comparator: Sham dose
• The current intensity for the sham dose will be set at sensory threshold, which will be less than that used for the effective dose. After beginning each exercise set, the current for the sham dose will decay to 0 mA within 30 s. In a preliminary study that included a sham dose of TENS, we found that only two of the experienced dancers in the sham group detected the gradual decline in TENS current from its initial value slightly above motor threshold when performing prescribed exercises.
Device: Transcutaneous electrical nerve stimulation
Electrical stimulation applied over selected leg muscle will activate sensory receptors that will transmit signals back into the central nervous system.




Primary Outcome Measures :
  1. Fatigue [ Time Frame: Changes at Weeks 4, 7, and 11 ]
    Questionnaire scores - PROMIS Fatigue (MS) 8a

  2. Walking limitations [ Time Frame: Changes at Weeks 4, 7, and 11 ]
    Questionnaire scores - MS Walking Scale-12

  3. Walking endurance [ Time Frame: Changes at Weeks 4, 7, and 11 ]
    6-min walk test in meters

  4. Mobility [ Time Frame: Changes at Weeks 4, 7, and 11 ]
    Assessment of static and dynamic balance with Mobility Lab, APDM Inc


Secondary Outcome Measures :
  1. Quality of life questionnaire [ Time Frame: Changes at Weeks 4, 7, and 11 ]
    Questionnaire scores

  2. Muscle strength [ Time Frame: Changes at Weeks 4, 7, and 11 ]
    Maximal force in newtons applied by the dorsiflexors and hip flexors of each leg



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women18-65 yrs
  • Able to read, understand, and speak English to ensure safe participation in the project
  • Clinical diagnosis of relapsing-remitting MS
  • Self-reported difficulty with walking
  • On stable doses of Ampyra, provigil, or other symptomatic-treating medications
  • No relapse or systemic steroids within the last 30 days
  • Able to arrange transportation to the Boulder campus

Exclusion Criteria:

  • Vision or hearing problems that have not been corrected
  • Problems with sensations to temperature, pressure, or pain
  • Any arm or leg problems that would influence the ability to hold a weight
  • Surgery to the arms or legs that continues to bother the participant
  • Metal implants
  • Medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in exercise training, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than treated basal cell cancer), other neurological disorders, or pregnancy
  • History of head injury or stroke
  • Taking antidepressants, anticholinergics, stimulants, sedatives, cannabis, illicit drugs or medications to treat herpes or neurologic pain.
  • Diagnosis of diabetes mellitus
  • Poorly controlled hypertension
  • History of seizure disorders
  • ≥2 alcoholic drinks/day, or present history (last 6 months) of drug abuse
  • Spasticity that requires the individual to change intended activities more often than once a week
  • Skin diseases or sensation problems in the legs or hands that influences some activities more often than once a week
  • Inability to attend exercise sessions 3 days per week for 6 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05500963


Contacts
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Contact: Roger Enoka, PhD 3034927232 enoka@colorado.edu

Sponsors and Collaborators
University of Colorado, Boulder
Publications of Results:
Other Publications:
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Responsible Party: Roger Enoka, Professor, University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT05500963    
Other Study ID Numbers: 22-0394
First Posted: August 15, 2022    Key Record Dates
Last Update Posted: August 15, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases