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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
Awards & highlights
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fatigue
Mobility
Walking endurance
+1 moreSecondary outcome measures
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
~870
Find a Location
Who is running the clinical trial?
University of Colorado, BoulderLead Sponsor
119 Previous Clinical Trials
29,134 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
29 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a head injury or stroke in the past.I am between 18 and 65 years old.My high blood pressure is not well-managed.I have trouble walking.I have been diagnosed with diabetes.I am currently taking medication for depression, pain, or using cannabis/illicit drugs.I haven't had a relapse or taken steroids in the last 30 days.I have ongoing issues from a surgery on my arm or leg.I have vision or hearing problems that are not corrected.I cannot attend exercise sessions 3 times a week for 6 weeks.I can get to the Boulder campus for my appointments.I can hold a weight without arm or leg problems affecting me.I have issues sensing temperature, pressure, or pain.I have a history of seizures.I am on a stable dose of medication for my symptoms.I often have skin or sensation issues in my hands or legs that affect my daily activities.My muscle stiffness forces me to change my plans more than once a week.I have been diagnosed with relapsing-remitting MS.I do not have major health issues that prevent me from exercising.
Research Study Groups:
This trial has the following groups:- Group 1: Effective dose
- Group 2: Sham dose
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the upper age limit for this trial limited to 85 years old?
"According to the selected criteria, potential participants must be 18 years of age or older and no more than 65."
Answered by AI
What sort of individuals is this clinical trial seeking to enrol?
"To qualify for the study, applicants must have multiple sclerosis and be within 18-65 years of age. The total number of participants accepted into the trial is 60 individuals."
Answered by AI
What is the aggregate size of this clinical trial's sample population?
"Affirmative. Clinicaltrials.gov elucidates that this clinical trial, initially posted on May 25th 2023, is actively recruiting patients. Sixty individuals must be sourced from a solitary medical facility to take part in the study."
Answered by AI
Is this experiment open to new participants?
"According to the details listed on clinicaltrials.gov, this medical study is still actively enrolling participants. The trial was initially advertised on May 25th 2023 and updated most recently on that same date."
Answered by AI
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