MedPath

Treatment of Progressive Multiple Sclerosis-related Cognitive Impairment, Fatigue, and Depression Using Repetitive Transcranial Magnetic Stimulatio

Phase 3
Not yet recruiting
Conditions
Nervous System Diseases
Registration Number
PACTR202403516079512
Lead Sponsor
Science Technology and Innovation Funding Authority
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
60
Inclusion Criteria

Definite MS patients according to 2017 revisions of the McDonald criteria.
-Progressive types of MS: Patient must fulfill diagnostic criteria of either: Secondary progressive MS (SPMS) or Primary progressive MS (PPMS)
-Free of clinical relapses for at least 3 months prior to inclusion.
-Free of steroid treatment for at least 6 weeks prior to inclusion.
-No change in their medications, whether disease modifying treatment or symptomatic therapy for at least 3 months if applicable.
-EDSS score below 6 points and stable over the past 3 months.
-A score of <34 on Symbol Digit Modalities Test, a score of = 12 on the Beck Depression Inventory (Beck et al., 1961), a score of = 38 on the Modified Fatigue Impact Scale.
-Level of education: at least can read and write.
-Written informed consent from the participants

Exclusion Criteria

-Conditions that could affect the participants’ level of cognition, fatigue, or depression, including; pregnancy, history of substance use disorder, history of significant neurological disorder other than MS, psychiatric, endocrinological, hepatic, renal, collagen, or other systemic comorbidities that could affect these symptoms.
-Contraindication to TMS: history of seizures, skull bone defects, metal fragments in the head, implanted metallic devices such as cardiac pacemakers, cochlear implants, medical pumps…, etc.
-Illiterate patients.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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