跳至主要内容
临床试验/NCT05560139
NCT05560139尚未招募不适用

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

Assiut University0 个研究点目标入组 36 人开始时间: 2022年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
36
主要终点
fatigue assessment scale

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

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.

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

experimental group

Experimental

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).

干预措施: a-tDCS (Device)

sham group

Sham Comparator

The sham group received ten sessions of sham stimulation for 20-minutes in each session.

干预措施: a-tDCS (Device)

结局指标

主要结局

fatigue assessment scale

时间窗: 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

时间窗: at post sessions, 1 month and 2 month post sessions

it is a scale from 0 to 10 to assess major fatigue

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Entsar Karem Abd Elazeem

Principal Investigator

Assiut University

相似试验