The Effect of Transcranial Direct Current Stimulation on Fatigue Among Multiple Sclerosis Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 36
- Primary Endpoint
- fatigue assessment scale
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, 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.
Eligibility Criteria
- Sex
- All
- Accepts 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.
Arms & Interventions
experimental group
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).
Intervention: a-tDCS (Device)
sham group
The sham group received ten sessions of sham stimulation for 20-minutes in each session.
Intervention: a-tDCS (Device)
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)
Investigators
Entsar Karem Abd Elazeem
Principal Investigator
Assiut University
