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

Primary Purpose

Multiple Sclerosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
a-tDCS
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Transcranial direct current stimulation, fatigue

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    experimental group

    sham group

    Arm Description

    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).

    The sham group received ten sessions of sham stimulation for 20-minutes in each session.

    Outcomes

    Primary Outcome Measures

    fatigue assessment scale
    it is a acale filed by the patient and it consists of scale from 1 to 10
    visual analogue scale
    it is a scale from 0 to 10 to assess major fatigue

    Secondary Outcome Measures

    changes in cortical excitability parameters at post 10th session compared to baseline measurements of cortical excitability parameters
    Detection of the relationship between cortical excitability changes{after 10th session) and changes in fatigue and HDS and QLoL changes..

    Full Information

    First Posted
    May 18, 2022
    Last Updated
    September 24, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05560139
    Brief Title
    The Effect of Transcranial Direct Current Stimulation on Fatigue Among Multiple Sclerosis Patients.Patients
    Official Title
    The Effect of Transcranial Direct Current Stimulation on Fatigue Among Multiple Sclerosis Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    May 1, 2023 (Anticipated)
    Study Completion Date
    September 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    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

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis
    Keywords
    Multiple sclerosis, Transcranial direct current stimulation, fatigue

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    ParticipantInvestigator
    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.
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    sham group
    Arm Type
    Sham Comparator
    Arm Description
    The sham group received ten sessions of sham stimulation for 20-minutes in each session.
    Intervention Type
    Device
    Intervention Name(s)
    a-tDCS
    Intervention Description
    Transcranial direct current stimulation
    Primary Outcome Measure Information:
    Title
    fatigue assessment scale
    Description
    it is a acale filed by the patient and it consists of scale from 1 to 10
    Time Frame
    at post sessions, 1 month and 2 month post sessions
    Title
    visual analogue scale
    Description
    it is a scale from 0 to 10 to assess major fatigue
    Time Frame
    at post sessions, 1 month and 2 month post sessions
    Secondary Outcome Measure Information:
    Title
    changes in cortical excitability parameters at post 10th session compared to baseline measurements of cortical excitability parameters
    Description
    Detection of the relationship between cortical excitability changes{after 10th session) and changes in fatigue and HDS and QLoL changes..
    Time Frame
    at post sessions, 1 month and 2 month post sessions

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Entsar karem, resident
    Phone
    0201030698902
    Email
    entsarkarem07@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Noha M Abo-Elfetoh, PHD
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Links:
    URL
    http://www.proquest.com/openview/adf0bd26e1b74ed3eeec5d8453bb657e/1?cbl=2029739&pq-origsite=gscholar&parentSessionId=D5TfE0n2xAVp%2F3af%2BtR8AsLlrvRjuA2r5I7x%2Bj%2BymuI%3D
    Description
    Compston A, Coles A. Multiple sclerosis. Lancet.
    URL
    http://link.springer.com/article/10.1007/s00415-006-0247-3
    Description
    Tellez N et al. Fatigue in multiple sclerosis persists over time: a longitudinal study. J Neurol
    URL
    https://pubmed.ncbi.nlm.nih.gov/16900749/
    Description
    Krupp L. Fatigue is intrinsic to multiple sclerosis (MS) and is the most commonly reported symptom of the disease. Mult Scler
    URL
    http://link.springer.com/article/10.1007/s13760-013-0198-2
    Description
    Ghajarzadeh M, Jalilian R, Eskandari G, et al. Fatigue in multiple sclerosis: Relationship with disease duration, physical disability, disease pattern, age and sex. Acta Neurol Belg
    URL
    http://bmcpublichealth.biomedcentral.com/articles/10.1186/1471-2458-6-59
    Description
    Chen MY, Wang EK, Jeng YJ. Adequate sleep among adolescents is positively associated with health status and health-related behaviors. BMC Public Health
    URL
    http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0078811
    Description
    Genova HM, Rajagopalan V, Deluca J, et al. Examination of cognitive fatigue in multiple sclerosis using functional magnetic resonance imaging and diffusion tensor imaging. PLoS ONE.
    URL
    https://content.iospress.com/articles/restorative-neurology-and-neuroscience/rnn130372
    Description
    Saiote C, Goldschmidt T, Timaus C, et al. Impact of transcranial direct current stimulation on fatigue in multiple sclerosis. Restor Neurol Neurosci
    URL
    https://link.springer.com/article/10.1186/s12984-018-0457-9
    Description
    Generalizing remotely supervised transcranial direct current stimulation (tDCS): feasibility and benefit in Parkinson's disease
    URL
    https://link.springer.com/article/10.1007/s00221-020-05827-6
    Description
    Multi-session anodal transcranial direct current stimulation enhances lower extremity functional performance in healthy older adults
    URL
    https://n.neurology.org/content/33/11/1444.short
    Description
    Rating neurologic impairment in multiple sclerosis
    URL
    https://jamanetwork.com/journals/jamapsychiatry/article-abstract/494356
    Description
    A Structured Interview Guide for the Hamilton Depression Rating Scale

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