Assistance Publique Hôpitaux de Paris-Hôpital Henri Mondor
Créteil, 94000, France
NCT Number: NCT05890885
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Créteil, 94000, France
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Real left prefrontal tDCS followed by sham tDCS after a 4-week washout period
Sham tDCS followed by real left prefrontal tDCS after a 4-week washout period
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Assistance Publique - Hôpitaux de Paris
Other
The Effect of Home-Based Transcranial Direct Current Stimulation on Fatigue in Multiple Sclerosis
Acronym: MSfatDCS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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