MS Fatigue and tDCS on Fatigue in Multiple Sclerosis

Not Applicable

Recruiting

• Conditions: Fatigue in Multiple Sclerosis
• Interventions: Procedure: Sham - Real left prefrontal tDCS; Procedure: Real left prefrontal tDCS - sham

• Registration Number: NCT05890885
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study First Submitted: 2022-01-05
• Status Verified: 2022-09
• Study Start: 2022-09-01
• Study First Submitted QC: 2023-05-25
• Last Update Submitted: 2023-05-25
• Study First Posted: 2023-06-06
• Last Update Posted: 2023-06-06
• Primary Completion: 2023-06-15
• Study Completion: 2023-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham - Real	Sham - Real left prefrontal tDCS	Sham tDCS followed by real left prefrontal tDCS after a 4-week washout period
Real - Sham	Real left prefrontal tDCS - sham	Real left prefrontal tDCS followed by sham tDCS after a 4-week washout period

Primary Outcome Measures

Name	Time	Method
Tiredness	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 Outcome Measures

Name	Time	Method
Anxiety	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.
Depression	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.
Alexithymia	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.
Cognitive functions	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.
MSQOL scale	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.

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Paris-Hôpital Henri Mondor; 🇫🇷 Créteil, France