Multiple Sclerosis
Conditions
Brief summary
The goal of this clinical trial is to evaluate whether transcranial direct current stimulation (tDCS) and cognitive rehabilitation can improve cognitive functions and neuronal plasticity in patients with multiple sclerosis (MS). The participant population consists of MS patients (both sexes, adults), who commonly experience cognitive impairment in addition to physical and psychological symptoms. The main questions it aims to answer are: Does tDCS applied over the left dorsolateral prefrontal cortex improve cognitive abilities in MS patients? Does the combination of tDCS and cognitive rehabilitation enhance neuroplasticity, as measured by DTI, BDNF levels, and acetylcholinesterase activity?
Interventions
DEVICEtDCS
A 30-minute tDCS session with the cathode placed over the left dorsolateral prefrontal cortex (DLPFC), delivered in 10 sessions over 2 weeks. This protocol targets cognitive improvement in MS patients
DEVICECognitive Rehabilitation
computer-based cognitive rehabilitation exercises. Conducted in 10 sessions over 2 weeks to enhance attention, memory, and neuroplasticity in MS patients.
DEVICESham tDCS
Sham stimulation applied over the left DLPFC for 30 minutes, mimicking the sensation of tDCS without delivering active current, over 10 sessions, used as control to blind participants to the intervention
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Age between 20 and 50 years. Diagnosed with relapsing-remitting multiple sclerosis (RRMS). Mild disability, defined as EDSS \< 5. Patients who attended the neurology clinic and are willing to participate.
Exclusion criteria
Presence of psychiatric disorders requiring treatment with neuroleptics. History of seizures. Left-handed individuals. Recent MS relapse requiring steroid treatment. Pregnant women. History of brain surgery or presence of intracranial clips.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in verbal memory performance measured by California Verbal Learning Test-II (CVLT-II) | Baseline and immediately after 10 intervention sessions | The CVLT-II assesses verbal learning and memory through a word recall task. Scores include total recall, short-delay recall, and long-delay recall. Assessments will be conducted at baseline and after 4 weeks of intervention. |
| Change in attention performance measured by Integrated Visual and Auditory Continuous Performance Test (IVA-2) | Baseline and immediately after 10 intervention sessions | The IVA-2 evaluates visual and auditory attention and response control. Scores include full-scale attention quotient, visual attention, auditory attention, and response control. Assessments will be conducted at baseline and post-intervention to assess changes in attention performance |
| Change in visuospatial memory performance measured by Rey-Osterrieth Complex Figure Test | Baseline and immediately after 10 intervention sessions | The Rey-Osterrieth Complex Figure Test evaluates visuospatial constructional ability and memory. Participants copy a complex figure (copy trial) and then reproduce it from memory immediately and after a delay. Assessments will be conducted at baseline and after completion of the tDCS intervention to assess changes in visuospatial memory performance. |
| Change in serum BDNF levels (ng/mL) | Baseline and immediately after 10 intervention sessions | Serum brain-derived neurotrophic factor (BDNF) concentration will be measured using an enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at baseline and after completion of the tDCS intervention. Changes in BDNF levels will be analyzed to assess neuroplasticity. |
| Change in white matter integrity measured by Diffusion Tensor Imaging (DTI) | Baseline and immediately after 10 intervention sessions | White matter integrity will be assessed using DTI MRI scans. Primary metrics include Fractional Anisotropy (FA) and Mean Diffusivity (MD) in predefined brain regions. Scans will be performed at baseline and after completion of the tDCS intervention to evaluate neuroplasticity-related changes |
| Change in acetylcholinesterase (AChE) activity in blood (U/mL) | Baseline and immediately after 10 intervention sessions | Acetylcholinesterase activity will be measured in blood samples using a spectrophotometric enzymatic assay. Samples will be collected at baseline and after completion of the tDCS intervention. Changes in AChE activity will be analyzed to assess cholinergic system function and neuroplasticity. |
Countries
Iran
Outcome results
None listed