Clinical trial NCT02987621: Can Transcranial Direct Current Stimulation Improve Ambulation and Fatigue Resistance in People With MS?
Official title: Can Transcranial Direct Current Stimulation Improve Ambulation and Fatigue Resistance in People With MS?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 14
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Leg Muscle Strength With and Without tDCS.
timeFrame: At session 1 and minimum of 7 days later
measure: Leg Muscle Endurance With and Without tDCS.
timeFrame: At session 1 and minimum of 7 days later.
measure: 6 Minute Walk Test
timeFrame: At session 1 and minimum of 7 days later
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Department of Health and Exercise Science
state: Colorado
Study officials:
References: