The Effect of Home-Based Transcranial Direct Current Stimulation on Fatigue in Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT05890885

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Placebo

  • Real left prefrontal tDCS - sham
  • Sham - Real left prefrontal tDCS

What it measured

Main measures

  • Tiredness

    12 weeks

    Thinking and memoryFatigue

Other measures (5)

  • Depression

    12 weeks

    Mood and sleep
  • Anxiety

    12 weeks

    Mood and sleep
  • Alexithymia

    before and after each stimulation period (active and simulated) and four weeks later (four weeks after the last stimulation session of each period).

  • MSQOL scale

    12 weeks

    Quality of life (reported by participants)
  • Cognitive functions

    12 weeks

    Thinking and memoryQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 75

Show the full criteria

Inclusion criteria

* Definite MS diagnosis according to the 2017 McDonald criteria * Fatigue since more than 6 months as assessed by fatigue severity scale (FSS>5) * Age between 18 and 75 years. * Stable pharmacological and physical treatment since at least one month * Affiliation to the social security regimen * Signature of the informed consent * Ability of the patient to understand the instructions for use of the pacemaker to ensure safe use

Exclusion criteria

* Relapses within the last two months * Active medical device implanted * Intracranial metal implants * Craniotomy, cranial trepanation, aneurysm * Uncontrolled epilepsy * Non-weaned alcoholism, sleep debt * Expanded disability status scale ≥ 6.5 * Severe depression based on Beck Depression inventory (BDI>19) * Daytime sleepiness based on Epworth Sleepiness Scale (ESS> 11) * Other neurologic and psychiatric diseases * Known pregnancy by the investigator or breastfeeding * Physical or mental incapacity to give informed consent * Participation in another study (exclusion period following a previous study should be ≥ 6 months) * Patients on AME * Patients under legal protection * Prisoners

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

About this trial

In the sponsor's words

The available therapeutic strategies for Multiple Sclerosis (MS)-related symptoms are usually faced with limited efficacy and numerous side effects. Patients with MS frequently suffer from fatigue, affective symptoms, and cognitive deficits.

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History

    1. Started

      Sept 2022

    2. Main results due

      Apr 2023

    3. Finished

      Apr 2023

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