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Completed

NCT Number: NCT05890885

MS Fatigue and tDCS on Fatigue in Multiple Sclerosis

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hôpitaux de Paris-Hôpital Henri Mondor

Créteil, 94000, France

About this study

For these reasons, non-invasive brain stimulation (NIBS) techniques, namely transcranial direct current stimulation (tDCS) might be of help in this context. tDCS is a new NIBS technique with a good safety profile, easy implementation, good patients' tolerance and little or no adverse effects. tDCS uses low levels of constant current delivered to specific brain area via sponge electrodes placed on the scalp. tDCS modifies the polarization of the exposed neuronal circuits. Indeed, it modulates the spontaneous neuronal excitability and activity by a tonic depolarization or hyperpolarization of resting membrane potential.

Therefore, applying a home-based intervention is of interest in a population suffering from high levels of physical disability prohibiting them from frequently coming to seek care at the hospital

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Real left prefrontal tDCS - sham

Procedure

Real left prefrontal tDCS followed by sham tDCS after a 4-week washout period

Sham - Real left prefrontal tDCS

Procedure

Sham tDCS followed by real left prefrontal tDCS after a 4-week washout period

Primary outcomes

  1. Tiredness

    Time frame: 12 weeks

    Modified Fatigue Impact Scale (MFIS): cognitive (10 items), physical (9 items) and psychosocial fatigue (2 items). It is a shortened version of the Fatigue Impact Scale that contains 21 of the original 40 items.

Secondary outcomes

  1. Depression

    Time frame: 12 weeks

    Mood will be assessed by the Hospital Anxiety and Depression Scale (HADS), which is composed of 7 questions that assess anxiety and 7 questions that assess depression.

  2. Anxiety

    Time frame: 12 weeks

    Mood will be assessed by the Hospital Anxiety and Depression Scale (HADS), which is composed of 7 questions that assess anxiety and 7 questions that assess depression.

  3. Alexithymia

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

    Alexithymia will be assessed using the 20-item Toronto Alexithymia Scale (TAS), which assesses the difficulties in analysing and describing one's own feelings and an externally oriented thinking.

  4. MSQOL scale

    Time frame: 12 weeks

    Quality of life will be assessed using the MS quality of life questionnaire (MSQOL), which is a multidimensional scale that assess different functions and can yield physical and mental composite scores.

  5. Cognitive functions

    Time frame: 12 weeks

    Cognitive functions will be assessed using the cognitive domain of the MSQOL, the Reading the Mind in the Eyes Test (RMET) and empathy quotient (EQ), which evaluated social cognition.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: MSfatDCS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 6, 2023
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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