Treatment of Progressive Multiple Sclerosis-related Cognitive Impairment, Fatigue, and Depression Using Repetitive Transcranial Magnetic Stimulatio
- 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
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
-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
Name Time Method To investigate the efficacy of high frequency rTMS on cognitive impairment using Symbol Digit Modalities Test, fatigue using Arabic version of Modified Fatigue Impact Scale, and depression using Arabic version of Beck Depression inventory in a sample of Egyptian progressive MS patients.
- Secondary Outcome Measures
Name Time Method To evaluate the effects of high frequency rTMS on the patients’ MS-related sphincteric dysfunction using the Arabic International Consultation on Incontinence Questionnaire-Short Form Scale, and on the patients’ walking performance using Timed 25-Foot walk test and Functional Ambulation Category.