Clinical trial NCT05560139: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Transcranial direct current stimulation
fatigue
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: fatigue assessment scale
timeFrame: at post sessions, 1 month and 2 month post sessions
measure: visual analogue scale
timeFrame: at post sessions, 1 month and 2 month post sessions
Secondary outcomes:
measure: changes in cortical excitability parameters at post 10th session compared to baseline measurements of cortical excitability parameters
timeFrame: at post sessions, 1 month and 2 month post sessions
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Noha M Abo-Elfetoh, PHD
role: STUDY_CHAIR
References: