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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real - Sham | Experimental | Real left prefrontal tDCS followed by sham tDCS after a 4-week washout period |
|
| Sham - Real | Experimental | Sham tDCS followed by real left prefrontal tDCS after a 4-week washout period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real left prefrontal tDCS - sham | Procedure | Real left prefrontal tDCS followed by sham tDCS after a 4-week washout period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tiredness | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | 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. | 12 weeks |
| Anxiety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samar AYACHE | Clinical Neurophysiology Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hôpitaux de Paris-Hôpital Henri Mondor | Créteil | 94000 | France |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
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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.
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| Sham - Real left prefrontal tDCS | Procedure | Sham tDCS followed by real left prefrontal tDCS after a 4-week washout period |
|
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.
| 12 weeks |
| Alexithymia | 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. | before and after each stimulation period (active and simulated) and four weeks later (four weeks after the last stimulation session of each period). |
| MSQOL scale | 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. | 12 weeks |
| Cognitive functions | 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. | 12 weeks |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |