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The Effect of Transcranial Direct Current Stimulation on Fatigue Among Multiple Sclerosis Patients.Patients

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ClinicalTrials.gov Identifier: NCT05560139
Recruitment Status : Not yet recruiting
First Posted : September 29, 2022
Last Update Posted : September 29, 2022
Sponsor:
Information provided by (Responsible Party):
Entsar Karem Abd Elazeem, Assiut University

Brief Summary:
This work is aimed to assess the long term effect of TDCS in fatigue management among MS patients

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: a-tDCS Not Applicable

Detailed Description:

Multiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system that is considered one of the most frequent causes of disability in the young adult.

Fatigue in MS may affect up to 80 % of the people with MS. It tends to persist over time once it appears. However, despite high frequency, fatigue remains poorly understood. Fatigue in MS is neither consistently linked to disease severity nor disease duration, although it is found to be worse in individuals with the secondary progressive subtype.

Fatigue is distinct from sleepiness, and fails to improve with adequate sleep. Multiple factors are thought to contribute to fatigue[7 , 8] with no specific biomarker or etiology yet confirmed.

A wide variety of therapies have been tested to reduce fatigue in MS, but unfortunately, none have been consistently effective. Transcranial direct current stimulation (tDCS) is a relatively recent therapeutic development that utilizes low-amplitude direct currents to induce changes in cortical excitability. Although various non-invasive neuromodulation technologies are available , tDCS has unique advantages compared to other stimulation methods such as its ease of use, lower cost, and greater safety and tolerability.

Small preliminary studies have observed that tDCS may be a promising treatment for MS fatigue, using sham-controlled crossover designs, with five tDCS sessions, using either a motor, sensory, or dorsolateral prefrontal cortex (DLPFC). Recently Chalah et al.[12] study demonstrated that DLPFC (left anodal) when compared the posterior parietal cortex led to the most fatigue specific improvements.

Thus, tDCS can reduce fatigue burden for people with MS, it may be possible to implement a tDCS therapy for symptomatic management of fatigue.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized clinical trial-controlled study to assess the ability of tDCS; anodal stimulation of left DLPC versus sham stimulation in improving fatigue in MS patients
Masking: Double (Participant, Investigator)
Masking Description: Anodal, or sham with a ratio 1:1 were placed in serially numbered opaque closed envelopes. Each patient was given a serial number from a computer generated randomization table, and was placed in the appropriate group after opening the corresponding sealed envelope.
Primary Purpose: Treatment
Official Title: The Effect of Transcranial Direct Current Stimulation on Fatigue Among Multiple Sclerosis Patients
Estimated Study Start Date : December 1, 2022
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: experimental group
Participants in the experimental groups received ten -sessions a-tDCS (1.5mA, 20minutes) anodal stimulation of left DLPC over two weeks duration (five sessions per week).
Device: a-tDCS
Transcranial direct current stimulation

Sham Comparator: sham group
The sham group received ten sessions of sham stimulation for 20-minutes in each session.
Device: a-tDCS
Transcranial direct current stimulation




Primary Outcome Measures :
  1. fatigue assessment scale [ Time Frame: at post sessions, 1 month and 2 month post sessions ]
    it is a acale filed by the patient and it consists of scale from 1 to 10

  2. visual analogue scale [ Time Frame: at post sessions, 1 month and 2 month post sessions ]
    it is a scale from 0 to 10 to assess major fatigue


Secondary Outcome Measures :
  1. changes in cortical excitability parameters at post 10th session compared to baseline measurements of cortical excitability parameters [ Time Frame: at post sessions, 1 month and 2 month post sessions ]
    Detection of the relationship between cortical excitability changes{after 10th session) and changes in fatigue and HDS and QLoL changes..



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Any adult patient will be fulfilling diagnostic criteria of Multiple sclerosis and could be providing consent for participation in the study, will be included in the study.

Exclusion Criteria:

  • any patient showed this following condition will be excluded from the study;
  • Any MS patient had any contraindication condition to use TMS or TCDS (such as epilepsy, head trauma, metallic procedure, cerebral insult)
  • Any patient had infection or febrile condition.
  • Any patient had other co morbid neurological or psychiatric disorders or systemic disease.
  • Any patient refuses participation in study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05560139


Contacts
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Contact: Entsar karem, resident 0201030698902 entsarkarem07@gmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: Noha M Abo-Elfetoh, PHD Assiut University
Additional Information:

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Responsible Party: Entsar Karem Abd Elazeem, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT05560139    
Other Study ID Numbers: TCDCS in MS
First Posted: September 29, 2022    Key Record Dates
Last Update Posted: September 29, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Entsar Karem Abd Elazeem, Assiut University:
Multiple sclerosis
Transcranial direct current stimulation
fatigue
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases