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

NCT05560139 | Unknown

• 1 other identifier: TCDCS in MS
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Transcranial direct current stimulation; fatigue

Outcome Measures

Primary Outcomes (2)

• fatigue assessment scale

  it is a acale filed by the patient and it consists of scale from 1 to 10

  at post sessions, 1 month and 2 month post sessions

• visual analogue scale

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

  at post sessions, 1 month and 2 month post sessions

Secondary Outcomes (1)

• 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

Study Arms (2)

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).

Device: a-tDCS

sham group

SHAM COMPARATOR

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

Device: a-tDCS

Interventions

a-tDCS DEVICE

Transcranial direct current stimulation

experimental group; sham group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Links

• Compston A, Coles A. Multiple sclerosis. Lancet.
• Tellez N et al. Fatigue in multiple sclerosis persists over time: a longitudinal study. J Neurol
• Krupp L. Fatigue is intrinsic to multiple sclerosis (MS) and is the most commonly reported symptom of the disease. Mult Scler
• 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
• Chen MY, Wang EK, Jeng YJ. Adequate sleep among adolescents is positively associated with health status and health-related behaviors. BMC Public Health
• 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.
• Generalizing remotely supervised transcranial direct current stimulation (tDCS): feasibility and benefit in Parkinson's disease
• Multi-session anodal transcranial direct current stimulation enhances lower extremity functional performance in healthy older adults

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Noha M Abo-Elfetoh, PHD

  Assiut University

  STUDY CHAIR

Central Study Contacts

Entsar karem, resident

CONTACT

0201030698902; entsarkarem07@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: September 29, 2022
• Study Start: December 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL