MS Fatigue and tDCS on Fatigue in Multiple Sclerosis (MSfatDCS)

May 25, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Créteil, France, 94000
        • Recruiting
        • Assistance Publique Hôpitaux de Paris-Hôpital Henri Mondor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real - Sham
Real left prefrontal tDCS followed by sham tDCS after a 4-week washout period
Procedure: Real left prefrontal tDCS - sham
Real left prefrontal tDCS followed by sham tDCS after a 4-week washout period
Experimental: Sham - Real
Sham tDCS followed by real left prefrontal tDCS after a 4-week washout period
Procedure: Sham - Real left prefrontal tDCS
Sham tDCS followed by real left prefrontal tDCS after a 4-week washout period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
Anxiety
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.
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).
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
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.
12 weeks
Cognitive functions
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Samar AYACHE, Clinical Neurophysiology Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

June 15, 2023

Study Completion (Estimated)

August 15, 2023

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

May 25, 2023

First Posted (Actual)

June 6, 2023

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP210747

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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