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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05560139
Enrollment
36
Registered
2022-09-29
Start date
2022-12-01
Completion date
2023-09-01
Last updated
2022-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis, Transcranial direct current stimulation, fatigue

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.

Interventions

DEVICEa-tDCS

Transcranial direct current stimulation

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.

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

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
fatigue assessment scaleat post sessions, 1 month and 2 month post sessionsit is a acale filed by the patient and it consists of scale from 1 to 10
visual analogue scaleat post sessions, 1 month and 2 month post sessionsit is a scale from 0 to 10 to assess major fatigue

Secondary

MeasureTime frameDescription
changes in cortical excitability parameters at post 10th session compared to baseline measurements of cortical excitability parametersat post sessions, 1 month and 2 month post sessionsDetection of the relationship between cortical excitability changes{after 10th session) and changes in fatigue and HDS and QLoL changes..

Contacts

Primary ContactEntsar karem, resident
entsarkarem07@gmail.com0201030698902

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026