MS Fatigue and tDCS on Fatigue in Multiple Sclerosis

NCT ID: NCT05890885

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-04-20

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

Conditions

Fatigue in Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Real - Sham

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

Group Type: EXPERIMENTAL

Real left prefrontal tDCS - sham

Intervention Type: PROCEDURE

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

Sham - Real

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

Group Type: EXPERIMENTAL

Sham - Real left prefrontal tDCS

Intervention Type: PROCEDURE

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

Interventions

Real left prefrontal tDCS - sham

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

Intervention Type: PROCEDURE

Sham - Real left prefrontal tDCS

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samar AYACHE

Role: PRINCIPAL_INVESTIGATOR

Clinical Neurophysiology Department

Locations

Assistance Publique Hôpitaux de Paris-Hôpital Henri Mondor

Créteil, , France

Countries

France

Other Identifiers

APHP210747

Identifier Type: -

Identifier Source: org_study_id