MSfatDCS: MS Fatigue and tDCS on Fatigue in Multiple Sclerosis

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT05890885

Collaborator

(none)

Enrollment

Location

Arms

11.4

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fatigue in Multiple Sclerosis	Procedure: Real left prefrontal tDCS - sham Procedure: Sham - Real left prefrontal tDCS	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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.

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jun 15, 2023

Anticipated Study Completion Date :

Aug 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Real - Sham Real left prefrontal tDCS followed by sham tDCS after a 4-week washout period	Procedure: Real left prefrontal tDCS - sham Real left prefrontal tDCS followed by sham tDCS after a 4-week washout period
Experimental: Sham - Real Sham tDCS followed by real left prefrontal tDCS after a 4-week washout period	Procedure: Sham - Real left prefrontal tDCS Sham tDCS followed by real left prefrontal tDCS after a 4-week washout period

Arm

Intervention/Treatment

Experimental: Real - Sham

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

Procedure: Real left prefrontal tDCS - sham

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

Experimental: Sham - Real

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

Procedure: Sham - Real left prefrontal tDCS

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

Outcome Measures

Primary Outcome Measures

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

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.
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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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