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
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Transcranial direct current stimulation, fatigue
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.
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
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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The Effect of Transcranial Direct Current Stimulation on Fatigue Among Multiple Sclerosis Patients.Patients
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