MS Fatigue and tDCS on Fatigue in Multiple Sclerosis (MSfatDCS)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Fatigue in Multiple Sclerosis

Treatments: Procedure: Real left prefrontal tDCS - sham; Procedure: Sham - Real left prefrontal tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT05890885

APHP210747

Details and patient eligibility

About

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.

Full 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

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 2 patient groups

Real - Sham

Experimental group

Description:

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

Treatment:

Procedure: Real left prefrontal tDCS - sham

Sham - Real

Experimental group

Description:

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

Treatment:

Procedure: Sham - Real left prefrontal tDCS