Recruiting

TENS with TreatmentReducing Fatigue in People With Multiple Sclerosis by Treatment With TENS

Sponsor:

University of Colorado, Boulder

Code:

NCT05500963

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Transcutaneous electrical nerve stimulation

Study Details

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.

Conditions

Multiple Sclerosis

Study ID

NCT05500963

Start date

Apr 25, 2023

Status verified date

Dec, 2024

Completion date

Nov 30, 2028

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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 measure

Fatigue [ Time Frame: Changes at Weeks 4, 7, and 11 ]
Walking limitations [ Time Frame: Changes at Weeks 4, 7, and 11 ]
Walking endurance [ Time Frame: Changes at Weeks 4, 7, and 11 ]
Mobility [ Time Frame: Changes at Weeks 4, 7, and 11 ]

Central Contacts and Locations

Central contacts

Roger Enoka, PhD

3034927232 enoka@colorado.edu

Locations

University of Colorado

Recruiting

Boulder, Colorado, United States, 80309

Contacts

Roger Enoka

303-492-7232 enoka@colorado.edu

More Information

Sponsor

University of Colorado, Boulder

Last update posted

Dec 9, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Boulder on 2024-12-09.