NCT05002062

Efficacy of Cognitive Behavioral Therapy on Fatigue, Cognition and Inflammatory Biomarkers in MS Patients

Completed NA Last updated 18 January 2022

What this trial tests

NA trial testing "RehaCom" computer-based cognitive training in addition to Conventional physical therapy program in Multiple Sclerosis in 40 participants. Completed in 7 June 2021.

Timeline

21 December 2020

Primary endpoint
18 May 2021

7 June 2021

Quick facts

Lead sponsor	Cairo University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	21 December 2020
Primary completion	18 May 2021
Estimated completion	7 June 2021
Sites	1 location across Egypt

Drugs / interventions tested

• "RehaCom" computer-based cognitive training in addition to Conventional physical therapy program
• Conventional physical therapy program

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Cairo University

Who can join

Adults 20 to 45, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There is a rising concern about quality of life of multiple sclerosis (MS) patients has emerged. Cognitive dysfunction with primary fatigue and there correlation to the level of disease inflammatory process has got great interest in MS research .

The aim of the present study was to examine the influence of using a computer-based cognitive behavioral therapy on primary fatigue, cognitive dysfunction, and inflammatory biomarkers for patients with MS.

Patients and methods A total of 40 MS patients (Expanded Disability Status Scale\<5) were divided into two groups, both groups are suffering cognitive decline (using RehaCom software to assess attention/concentration, memory and reaction behavior) with primary fatigue according to the Fatigue Severity Scale (FSS\>36). Patients with depression and sleep problems were excluded from the study. Patients in both groups have elevated serum levels of tumor necrosis factor-α (TNF-α) and interferon-γ (IFN-γ).

Patients in (G1) underwent conventional physical therapy program for MS including aerobic training, resistive training and a flexibility program, patients in (G2) underwent an intensive computer-based cognitive program for attention, concentration, memory and reaction behavior using the RehaCom software.

The conventional physical therapy interventions for both (G1) sustained for three months, 45 minutes to 1 hour, 3 times/week. The computer-based cognitive behavioral therapy for patients in (G2) was prescribed as following (45 minutes to 1 hour a session, 3 times/week for continues three months).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Adjunctive strategies in multiple sclerosis treatment: non-pharmacological approaches and their potential clinical implications.
   Wang Y, Yan W, Yao L, Liu W, et al · · 2026 · PMID 41947223 · DOI 10.1186/s12967-026-08101-5