Can Transcranial Direct Current Stimulation Improve Ambulation and Fatigue Resistance in People With MS?

NCT ID: NCT02987621

Last Updated: 2020-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-06-30

Brief Summary

In this project the investigators will be using non-invasive brain stimulation on people with multiple sclerosis (PwMS) to improve leg muscle function. Two groups of participants will be recruited. One group will perform strength testing with and without the brain stimulation. The second group of participants will perform a fatigue task, pulling against a wire at a low level of force, with and without the brain stimulation. This type of brain stimulation has been shown to transiently improve strength and fatigue measures in other populations, e.g. aged, Parkinson's, and improve cognitive abilities in people with multiple sclerosis. It is the investigator's hope that the increases in performance seen in other patient groups will also occur in people with multiple sclerosis. Future investigations will look to apply the non-invasive brain stimulation technique during physical rehabilitation to improve short and long term outcomes related to physical function.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Sham first, wash out 7 days, then tDCS

Separated by a minimum of 7 days from the sham treatment in a counterbalance order, all participants will perform leg muscle strength and fatigue testing once with tDCS stimulation.

Leg muscle strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials.

Sham: Less than 0V of Transcranial Direct Current Stimulation tDCS: Less than 10V of Transcranial Direct Current Stimulation

Group Type: EXPERIMENTAL

tDCS

Intervention Type: DEVICE

Less than 10V of Transcranial Direct Current Stimulation. Sham 0V of Transcranial Direct Current Stimulation.

tDCS first, wash out 7 days, then Sham

Separated by a minimum of 7 days from the sham treatment in a counterbalance order, all participants will perform leg muscle strength and fatigue testing once with tDCS stimulation.

Leg muscle strength testing will be measured by performing a series of maximal effort knee extension, knee flexion, plantar/dorsi-flexion trials.

Sham: Less than 0V of Transcranial Direct Current Stimulation tDCS: Less than 10V of Transcranial Direct Current Stimulation

Group Type: EXPERIMENTAL

tDCS

Intervention Type: DEVICE

Less than 10V of Transcranial Direct Current Stimulation. Sham 0V of Transcranial Direct Current Stimulation.

Interventions

tDCS

Less than 10V of Transcranial Direct Current Stimulation. Sham 0V of Transcranial Direct Current Stimulation.

Intervention Type: DEVICE

Other Intervention Names

The Travel Model v2.0 Advanced tDCS Kit; The Brian Simulator

Eligibility Criteria

Inclusion Criteria

• Medically diagnosed with MS
• Moderate disability (Patient Determined Disease Steps score 2-6)
• Self-reported differences in function between the legs (2-5 on a 1-5 scale)
• People with MS with physician clearance

Exclusion Criteria

• A relapse of disease symptoms in the last 60 days
• A condition unrelated to MS that would exacerbate fatigue, such as anemia, hypothyroidism, shiftwork-related fatigue, B12 deficiency, major sleep disorder, or major depressive disorder
• Medical diagnosis or condition that makes participating in exercise training dangerous, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than treated basal cell cancer), other neurological disorders, or pregnancy
• History of heart attack or current diagnosis of cardiovascular disease
• History of seizure disorders (or on medications known to lower seizure threshold), hydrocephalus (buildup of fluid in the brain), or diabetes
• Alcohol dependence or abuse (>2 drinks/day), or present history (last six months) of drug abuse
• History of significant traumatic brain injury or hydrocephalus
• Pregnancy
• Recent hospitalization (within the last 3 months) or enforced bed rest/sedentary state.
• Presence of metal is present or implanted device or metal object that is not safe for TMS.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Colorado State University

OTHER

Sponsor Role: lead

Responsible Party

Thorsten Rudroff

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Health and Exercise Science

Fort Collins, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

16-6856H

Identifier Type: -

Identifier Source: org_study_id