TENS for Multiple Sclerosis Fatigue

N/A

Recruiting

Research Sponsored by University of Colorado, Boulder

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up changes at weeks 4, 7, and 11

Summary

This trial tests whether TENS can reduce fatigue in people with MS.

Who is the study for?

This trial is for adults aged 18-65 with relapsing-remitting Multiple Sclerosis who experience walking difficulties. They must be on stable medication, have no recent MS relapses or steroid use, and can travel to Boulder campus. Excluded are those with uncorrected vision/hearing issues, certain physical conditions, metal implants, major diseases like HIV/cancer, history of head injury/stroke/seizures/drug abuse/alcoholism.

What is being tested?

The study tests if TENS (Transcutaneous electrical nerve stimulation) can reduce fatigue in people with MS. Participants will be randomly assigned to receive either the real TENS treatment or a sham (fake) version to compare effectiveness.

What are the potential side effects?

TENS is generally safe but may cause skin irritation where the electrodes are placed. Some individuals might experience tingling sensations during treatment or muscle twitching.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ changes at weeks 4, 7, and 11

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~changes at weeks 4, 7, and 11

This trial's timeline: 3 weeks for screening, Varies for treatment, and changes at weeks 4, 7, and 11 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fatigue

Mobility

Walking endurance

+1 more

Secondary study objectives

Muscle strength

Quality of life questionnaire

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Effective doseExperimental Treatment1 Intervention

• 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.

Group II: Sham dosePlacebo Group1 Intervention

• 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcutaneous electrical nerve stimulation

2010

Completed Phase 4

~970

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