Can Transcranial Direct Current Stimulation Improve Ambulation and Fat

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

CompletedNot a drug-phase studyMS (type not specified)NCT02987621

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • tDCS

Results by group

Leg Muscle Strength With and Without tDCS.

At session 1 and minimum of 7 days later

GroupValueIntervalNumber analysed
All Study Participants323 Newtons15 (Standard Error)14
All Study Participants330 Newtons98 (Standard Error)14

All Study Participants

323

All Study Participants

330

Leg Muscle Endurance With and Without tDCS.

At session 1 and minimum of 7 days later.

GroupValueIntervalNumber analysed
All Study Participants1087 seconds938 (Standard Error)14
All Study Participants872 seconds547 (Standard Error)14

All Study Participants

1087

All Study Participants

872

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
All Study Participants-Leg Muscle Strength tDCS140 (0.0%)0
All Study Participants-Leg Muscle Strength Sham140 (0.0%)0
All Study Participants-Leg Muscle Endurance tDCS140 (0.0%)0
All Study Participants-Leg Muscle Endurance Sham140 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Leg Muscle Strength With and Without tDCS.

    At session 1 and minimum of 7 days later

    Physical function

  • Leg Muscle Endurance With and Without tDCS.

    At session 1 and minimum of 7 days later.

    FatiguePhysical function

  • 6 Minute Walk Test

    At session 1 and minimum of 7 days later

    Walking and mobilityPhysical function

Who could take part

MS (type not specified) · 30 to 60

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Nov 2016

    2. Main results due

      Jun 2018

    3. Finished

      Jun 2018

    4. Results posted

      Feb 2020

    Assembled by software from public sources.