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

NCT ID: NCT05560139

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-09-01

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

a-tDCS

Intervention Type: DEVICE

Transcranial direct current stimulation

sham group

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

Group Type: SHAM_COMPARATOR

a-tDCS

Intervention Type: DEVICE

Transcranial direct current stimulation

Interventions

a-tDCS

Transcranial direct current stimulation

Intervention Type: DEVICE

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Entsar Karem Abd Elazeem

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noha M Abo-Elfetoh, PHD

Role: STUDY_CHAIR

Assiut University

Central Contacts

Entsar karem, resident

Role: CONTACT

entsarkarem07@gmail.com

0201030698902

Related Links

http://www.proquest.com/openview/adf0bd26e1b74ed3eeec5d8453bb657e/1?cbl=2029739&pq-origsite=gscholar&parentSessionId=D5TfE0n2xAVp%2F3af%2BtR8AsLlrvRjuA2r5I7x%2Bj%2BymuI%3D

Compston A, Coles A. Multiple sclerosis. Lancet.

http://link.springer.com/article/10.1007/s00415-006-0247-3

Tellez N et al. Fatigue in multiple sclerosis persists over time: a longitudinal study. J Neurol

https://pubmed.ncbi.nlm.nih.gov/16900749/

Krupp L. Fatigue is intrinsic to multiple sclerosis (MS) and is the most commonly reported symptom of the disease. Mult Scler

http://link.springer.com/article/10.1007/s13760-013-0198-2

Ghajarzadeh M, Jalilian R, Eskandari G, et al. Fatigue in multiple sclerosis: Relationship with disease duration, physical disability, disease pattern, age and sex. Acta Neurol Belg

http://bmcpublichealth.biomedcentral.com/articles/10.1186/1471-2458-6-59

Chen MY, Wang EK, Jeng YJ. Adequate sleep among adolescents is positively associated with health status and health-related behaviors. BMC Public Health

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0078811

Genova HM, Rajagopalan V, Deluca J, et al. Examination of cognitive fatigue in multiple sclerosis using functional magnetic resonance imaging and diffusion tensor imaging. PLoS ONE.

https://link.springer.com/article/10.1186/s12984-018-0457-9

Generalizing remotely supervised transcranial direct current stimulation (tDCS): feasibility and benefit in Parkinson's disease

https://link.springer.com/article/10.1007/s00221-020-05827-6

Multi-session anodal transcranial direct current stimulation enhances lower extremity functional performance in healthy older adults

Other Identifiers

TCDCS in MS

Identifier Type: -

Identifier Source: org_study_id