NCT06473753

Brief Summary

Primary objective

  • Studying the effect of low frequency rTMS on bladder symptoms in patients with MS.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2023

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

December 6, 2023

Last Update Submit

June 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical assessment of bowel, bladder, and sexual dysfunction in patients with MS though applying specific related scales

    Clinical assessment of bowel, bladder, and sexual dysfunction in patients with MS though applying specific related scales

    Baseline

Secondary Outcomes (1)

  • Motor evoked potential using TMS with parameters gained using single pulse paradigm

    Baseline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient diagnosed with multiple sclerosis according to McDonald's criteria 2017 attending outpatient clinic, department of neurology and psychiatry, Assuit university hospital

You may qualify if:

  • Adult patient with definite Multiple sclerosis 2-Age \> 18 years 3-both sexes 4-patient with complaint of any of pelvic floor dysfunction (bladder, sexual or bowel)

You may not qualify if:

  • Patients with other systemic or neurological disorder affecting sphincter.
  • Patients taking drugs affecting sphincter.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Belbasis L, Bellou V, Evangelou E, Tzoulaki I. Environmental factors and risk of multiple sclerosis: Findings from meta-analyses and Mendelian randomization studies. Mult Scler. 2020 Apr;26(4):397-404. doi: 10.1177/1352458519872664. Epub 2019 Sep 6.

    PMID: 32249718BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 6, 2023

First Posted

June 25, 2024

Study Start

October 1, 2024

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

June 25, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL