MS Fatigue and tDCS on Fatigue in Multiple Sclerosis

Fatigue in Multiple Sclerosis Clinical Trial

— MSfatDCS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05890885
• Other study ID #: APHP210747
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: September 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Samar AYACHE
• Phone: +33149814662
• Email: samar.ayache[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Fatigue in Multiple Sclerosis
• Multiple Sclerosis
• Sclerosis

Intervention

Procedure:
• Real left prefrontal tDCS - sham
Real left prefrontal tDCS followed by sham tDCS after a 4-week washout period
• Sham - Real left prefrontal tDCS
Sham tDCS followed by real left prefrontal tDCS after a 4-week washout period

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Paris-Hôpital Henri Mondor	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Anxiety	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
Secondary	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).
Secondary	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
Secondary	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