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Clinical Trials/NCT05560139
NCT05560139
Not yet recruiting
Not Applicable

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

Assiut University0 sites36 target enrollmentDecember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Assiut University
Enrollment
36
Primary Endpoint
fatigue assessment scale
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
September 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Entsar Karem Abd Elazeem

Principal Investigator

Assiut University

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.

Outcomes

Primary Outcomes

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

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 Outcomes

  • changes in cortical excitability parameters at post 10th session compared to baseline measurements of cortical excitability parameters(at post sessions, 1 month and 2 month post sessions)

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