NCT05890885

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

January 5, 2022

Last Update Submit

January 20, 2026

Conditions

Fatigue in Multiple Sclerosis

Keywords

FatigueMultiple sclerosisAnodal tDCSPrefrontal cortex

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Depression

    12 weeks

  • Anxiety

    12 weeks

  • Alexithymia

    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

    12 weeks

  • Cognitive functions

    12 weeks

Study Arms (2)

Real - Sham

EXPERIMENTAL

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

Procedure: Real left prefrontal tDCS - sham

Sham - Real

EXPERIMENTAL

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

Procedure: Sham - Real left prefrontal tDCS

Interventions

Real left prefrontal tDCS - shamPROCEDURE

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

Real - Sham
Sham - Real left prefrontal tDCSPROCEDURE

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

Sham - Real

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Patients on AME
  • Patients under legal protection
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Paris-Hôpital Henri Mondor

Créteil, 94000, France

Location

MeSH Terms

Conditions

FatigueMultiple Sclerosis

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Samar AYACHE

    Clinical Neurophysiology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2022

First Posted

June 6, 2023

Study Start

September 1, 2022

Primary Completion

April 20, 2023

Study Completion

April 20, 2023

Last Updated

January 22, 2026

Record last verified: 2026-01

Locations

FR(1)