Cortical Inhibition in Patients With Multiple Sclerosis

NCT07128160 | Not Yet Recruiting

• 1 other identifier: cortical intibition in ms
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.To investigate the relationship between corticospinal inhibition and clinical, psychological, and cognitive features in MS patients.
2. 2.To examine the association between corticospinal inhibition and radiological findings, including MRI lesions and white matter damage

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis

Outcome Measures

Primary Outcomes (3)

• Motor Evoked Potential (MEP)

  Obtained using single-pulse transcranial magnetic stimulation over the primary motor cortex. Latency is defined as the time interval from the TMS pulse to the onset of the muscle response. Longer latencies may indicate impaired corticospinal conduction.

  baseline

• Cortical Silent Period (CSP)

  Recorded during sustained voluntary muscle contraction using TMS. The silent period is the time during which voluntary electromyographic activity is suppressed following the motor evoked potential. CSP reflects intracortical inhibitory mechanisms.

  baseline

• Interhemispheric Inhibition (IHI)

  The interhemispheric inhibition (IHI) is a parameter reflecting the transcallosal GABA-mediated inhibitory activity. It will be obtained at complete muscle rest using figure-of-eight coils (MC-B70; MagVenture)

  baseline

Secondary Outcomes (2)

• Toronto Alexithymia Scale (TAS-20)

  baseline

• Fatigue Severity Scale (FSS)

  baseline

Study Arms (1)

multiple sclerosis

patients with multiple sclerosis

Other: Clinical and Demographic Assessment; Other: Corticospinal Inhibition Assessment; Other: Radiological Assessment

Interventions

Clinical and Demographic Assessment OTHER

1. Expanded Disability Status Scale (EDSS) (Kurtzke, 1983): This scale will be used for neurological disability assessment 2. Multiple Sclerosis Functional Composite (MSFC): This composite will be used for the assessment of functional performance in patients with MS. It includes: a) Timed 25-foot walk (T25FW), b) Nine-hole peg test (9HPT) for both hands, and c) Paced auditory serial addition test (PASAT). 3. Toronto Alexithymia Scale (TAS-20): This scale reports Alexithymia. It is a 20-item self-report questionnaire measuring three domains: Difficulty identifying feelings (DIF), Difficulty describing feelings (DDF), and externally oriented thinking (EOT). A score ≥ 61 indicates alexithymia (Bagby, Parker \& Taylor, 1994). 4. Montreal Cognitive Assessment (MoCA), (Nasreddine ZS et al, 2005): a 30-point tool that investigates visuospatial abilities, language, attention, memory, abstraction, and orientation, with scores \<26 suggestive of mild cognitive impairment

multiple sclerosis

Corticospinal Inhibition Assessment OTHER

Corticospinal inhibition will be evaluated using Transcranial Magnetic Stimulation (TMS) (Ayache et al., 2022; Chalah et al., 2018). All TMS assessments will be conducted according to international safety guidelines. The following parameters will be measured: 1. Motor Evoked Potentials (MEPs) will be recorded from the abductor pollicis brevis muscle. 2. Cortical silent period (CSP) will be assessed to measure corticospinal excitability and inhibition. 3. The interhemispheric inhibition (IHI) is a parameter reflecting the transcallosal GABA-mediated inhibitory activity. It will be obtained at complete muscle rest using figure-of-eight coils (MC-B70; MagVenture), connected with a MagPro\_R20 (Medtronic Inc., USA) generator connected to a butterfly coil.

multiple sclerosis

Radiological Assessment OTHER

All patients will undergo brain and spinal cord Magnetic Resonance Imaging (MRI) using a 1.5T scanner. Brain MRI sequences include: T1-weighted, T2-weighted, FLAIR, and post-contrast sequences. Spinal MRI (cervical and thoracic) includes T2-weighted and STIR sequences. Radiological assessment focused on: * Number and location of T2/FLAIR lesions * Presence of contrast-enhancing lesions * Degree of brain atrophy (qualitatively) * Spinal cord lesion load A neuroradiologist will review MRI findings, blinded to the clinical and neuropsychological data

multiple sclerosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

the sample size calculation was performed using EpI-Info 2002 software statistical package designed by World Health Organization (WHO) and by Centers for Disease Control and Prevention (CDC). The sample size was calculated based on the following considerations: 95% confidence level and according to a previous study (Chaves, A. R.,2024). Therefore, resulting sample size of 82 thus sample size increased to 90 Chaves, A. R., Tremblay, S., Pilutti, L., \& Ploughman, M. (2024). Lowered ratio of corticospinal excitation to inhibition predicts greater disability, poorer motor and cognitive function in multiple sclerosis. Heliyon, 10(15).

You may qualify if:

• Age 18 years or older.
• Diagnosis of RRMS based on the 2017 McDonald Criteria.
• Expanded Disability Status Scale (EDSS) score ≤ 6.5.
• On a stable dose of disease-modifying therapy (DMT) for at least 3 months or naeive patients not use DMT before
• Free of relapses or steroids treatment (at least 3 months after a relapse or corticosteroid therapy)
• Ability to give informed consent and complete neuropsychological assessments.

You may not qualify if:

• Presence of other neurological or psychiatric disorders (e.g., major depression, bipolar disorder, schizophrenia).
• History of alcohol or substance abuse.
• Contraindications to MRI (e.g., pacemakers, metallic implants) and TMS (i.e., history of seizures, presence of ferromagnetic implants in the head area).
• Medications known to alter the corticospinal excitability.
• Severe visual deficit, motor weakness, or intellectual impairment (as per the Mini-Mental State Exam score \< 24).

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Neurology and Psychiatry, Assiut University

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08