Transcranial Direct Current Stimulation to Lower Neuropathic Pain and Fatigue in People With Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT03870048

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

  • transcranial direct current stimulation

Results by group

Neuropathic Pain Questionnaire (NPQ) Contains 12 Items.

2 Months

GroupValueIntervalNumber analysed
tDCS Effects on Pain and Fatigue21.3 Points19.5 (Standard Deviation)6
Sham Effects on Pain and Fatigue10.3 Points13.5 (Standard Deviation)6

tDCS Effects on Pain and Fatigue

21.3

Sham Effects on Pain and Fatigue

10.3

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
tDCS Effects on Pain and Fatigue60 (0.0%)0
Sham Effects on Pain and Fatigue60 (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

  • Neuropathic Pain Questionnaire (NPQ) Contains 12 Items.

    2 Months

    Pain

Other measures (1)

  • Fatigue Severity Scale (FSS) Contains Nine Statements That Attempt to Explore Severity of Fatigue Symptoms.

    2 Months

    Fatigue

Who could take part

MS (type not specified) · 18 to 70

Show the full criteria

Inclusion criteria

* Medically diagnosed with Multiple Sclerosis * 18-70 yrs. of age, moderate disability (Patient Determined Disease Steps (PDDS) core 2-6) * Self-reported differences in function between legs * Able to walk for 6 min * Presenting with chronic, drug-resistant, neuropathic pain.

Exclusion criteria

* Relapse within last 60 days * High risk for cardiovascular disease (ACSM risk classification) * Changes in disease modifying medications within last 45 days * Concurrent neurological/neuromuscular disease * Hospitalization within last 90 days * Diagnosed depression * Inability to understand/sign informed consent.

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

About this trial

In the sponsor's words

The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) on neuropathic pain and fatigue in people with MS. The investigators will conduct tDCS or sham on 5 consecutive days. They will evaluate pain and fatigue with specific questionnaires and measure fatigability with an isokinetic device. The research question is whether tDCS can lessen neuropathic pain and increase fatigue resistance in people with MS. It is hypothesized, that less neuropathic pain and increased fatigue resistance after the tDCS sessions.

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History

    1. Started

      Apr 2019

    2. Main results due

      Mar 2020

    3. Finished

      Mar 2020

    4. Results posted

      Aug 2022

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