search
Back to results

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

Primary Purpose

Fatigue in Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Real left prefrontal tDCS - sham
Sham - Real left prefrontal tDCS
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue in Multiple Sclerosis focused on measuring Fatigue, Multiple sclerosis, Anodal tDCS, Prefrontal cortex

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique Hôpitaux de Paris-Hôpital Henri MondorRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Real - Sham

Sham - Real

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
January 5, 2022
Last Updated
May 25, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT05890885
Brief Title
MS Fatigue and tDCS on Fatigue in Multiple Sclerosis
Acronym
MSfatDCS
Official Title
The Effect of Home-Based Transcranial Direct Current Stimulation on Fatigue in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue in Multiple Sclerosis
Keywords
Fatigue, Multiple sclerosis, Anodal tDCS, Prefrontal cortex

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real - Sham
Arm Type
Experimental
Arm Description
Real left prefrontal tDCS followed by sham tDCS after a 4-week washout period
Arm Title
Sham - Real
Arm Type
Experimental
Arm Description
Sham tDCS followed by real left prefrontal tDCS after a 4-week washout period
Intervention Type
Procedure
Intervention Name(s)
Real left prefrontal tDCS - sham
Intervention Description
Real left prefrontal tDCS followed by sham tDCS after a 4-week washout period
Intervention Type
Procedure
Intervention Name(s)
Sham - Real left prefrontal tDCS
Intervention Description
Sham tDCS followed by real left prefrontal tDCS after a 4-week washout period
Primary Outcome Measure Information:
Title
Tiredness
Description
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
Secondary Outcome Measure Information:
Title
Depression
Description
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
Title
Anxiety
Description
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
Title
Alexithymia
Description
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
before and after each stimulation period (active and simulated) and four weeks later (four weeks after the last stimulation session of each period).
Title
MSQOL scale
Description
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
Title
Cognitive functions
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samar AYACHE
Phone
+33149814662
Email
samar.ayache@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samar AYACHE
Organizational Affiliation
Clinical Neurophysiology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Paris-Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samar AYACHE, Pr
Phone
0033-149814662
Email
samar.ayache@aphp.fr

12. IPD Sharing Statement

Learn more about this trial

MS Fatigue and tDCS on Fatigue in Multiple Sclerosis

We'll reach out to this number within 24 hrs