Fatigue in Multiple SclerosisMSfatDCSNCT05890885
MS Fatigue and tDCS on Fatigue in Multiple Sclerosis
A study of Fatigue in Multiple Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fatigue in Multiple Sclerosis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to 20 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Relapses within the last two months
- Active medical device implanted
- Intracranial metal implants
- Craniotomy, cranial trepanation, aneurysm
- Uncontrolled epilepsy
- Non-weaned alcoholism, sleep debt
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Paris-Hôpital Henri Mondor
Créteil, 94000
About this study
Official title: The Effect of Home-Based Transcranial Direct Current Stimulation on Fatigue in Multiple Sclerosis
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.
Read the 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
- Conditions
- Fatigue in Multiple Sclerosis
- Being tested
- Real left prefrontal tDCS - sham, Sham - Real left prefrontal tDCS
- Keywords
- Fatigue, Multiple sclerosis, Anodal tDCS, Prefrontal cortex
- Medical subject headings
- Fatigue, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real left prefrontal tDCS - shamProcedure or surgery
Real left prefrontal tDCS followed by sham tDCS after a 4-week washout period
Sham - Real left prefrontal tDCSProcedure or surgery
Sham tDCS followed by real left prefrontal tDCS after a 4-week washout period
| Study group | Role | What they receive |
|---|---|---|
| Real - Sham | Experimental | Real left prefrontal tDCS followed by sham tDCS after a 4-week washout period Receives: Procedure: Real left prefrontal tDCS - sham |
| Sham - Real | Experimental | Sham tDCS followed by real left prefrontal tDCS after a 4-week washout period Receives: Procedure: Sham - Real left prefrontal tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (5)
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.
Measured: 12 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start1 Sep 2022
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue in Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samar AYACHE, Principal investigator, Clinical Neurophysiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890885
- Sponsor's protocol ID
- APHP210747
- Acronym
- MSfatDCS
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2022
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Home-Based Transcranial Direct Current Stimulation on Fatigue in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05890885
- Acronym / sponsor ID
- MSfatDCS / APHP210747
- Conditions
- Fatigue in Multiple Sclerosis
- Keywords
- Fatigue, Multiple sclerosis, Anodal tDCS, Prefrontal cortex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Real - Sham | Experimental | Procedure: Real left prefrontal tDCS - shamReal left prefrontal tDCS followed by sham tDCS after a 4-week washout period |
| Sham - Real | Experimental | Procedure: Sham - Real left prefrontal tDCSSham tDCS followed by real left prefrontal tDCS after a 4-week washout period |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- Relapses within the last two months
- Active medical device implanted
- Intracranial metal implants
- Craniotomy, cranial trepanation, aneurysm
- Uncontrolled epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real left prefrontal tDCS - shamReal left prefrontal tDCS followed by sham tDCS after a 4-week washout period | Procedure or surgery | Real - Sham |
| Sham - Real left prefrontal tDCSSham tDCS followed by real left prefrontal tDCS after a 4-week washout period | Procedure or surgery | Sham - Real |
Primary outcome
Tiredness
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.
5 secondary outcomes
Depression
Time frame: 12 weeks
Anxiety
Time frame: 12 weeks
Alexithymia
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).
MSQOL scale
Time frame: 12 weeks
Cognitive functions
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samar AYACHE principal investigator
Clinical Neurophysiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Fatigue in Multiple Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tiredness (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.