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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05560139
Other study ID # TCDCS in MS
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2022
Est. completion date September 1, 2023

Study information

Verified date September 2022
Source Assiut University
Contact Entsar karem, resident
Phone 0201030698902
Email entsarkarem07@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 36
Est. completion date September 1, 2023
Est. primary completion date May 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
a-tDCS
Transcranial direct current stimulation

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary fatigue assessment scale it is a acale filed by the patient and it consists of scale from 1 to 10 at post sessions, 1 month and 2 month post sessions
Primary visual analogue scale it is a scale from 0 to 10 to assess major fatigue at post sessions, 1 month and 2 month post sessions
Secondary 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.. at post sessions, 1 month and 2 month post sessions
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