Clinical trial NCT05890885: MS Fatigue and tDCS on Fatigue in Multiple Sclerosis
Official title: The Effect of Home-Based Transcranial Direct Current Stimulation on Fatigue in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fatigue in Multiple Sclerosis
Keywords: Fatigue
Multiple sclerosis
Anodal tDCS
Prefrontal cortex
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: During a routine visit in the Department of Neurology for monitoring MS disease, patients undergo a routine neurological exam which will serve later on to check inclusion/exclusion criteria (i.e., this exam will help rating the disability using the Expanded Disability Status Scale that is also routinely performed in all patients with MS). If a patient is interested in this research, the information form will be given to him/her by one of the study investigators (screening visit).

Then, after a period of reflection of at least one week after the screening visit, one study investigator will call the patient to inquire about her/his willingness to participate to the study. If the patient agrees to participate in this research, (s)he will be invited for a baseline visit in the Department of Clinical Neurophysiology for inclusion in the study.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility 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

Primary outcomes:
measure: Tiredness
timeFrame: 12 weeks
Secondary outcomes:
measure: Depression
timeFrame: 12 weeks
measure: Anxiety
timeFrame: 12 weeks
measure: Alexithymia
timeFrame: before and after each stimulation period (active and simulated) and four weeks later (four weeks after the last stimulation session of each period).
measure: MSQOL scale
timeFrame: 12 weeks
measure: Cognitive functions
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Créteil
country: France
facility: Assistance Publique Hôpitaux de Paris-Hôpital Henri Mondor
Study officials:
affiliation: Clinical Neurophysiology Department
name: Samar AYACHE
role: PRINCIPAL_INVESTIGATOR
References: