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Clinical Trials/NCT06265922
NCT06265922
Completed
Not Applicable

Effect of Cerebellar Repetitive Transcranial Magnetic Stimulation on Coordination in Patients with Multiple Sclerosis

Cairo University1 site in 1 country30 target enrollmentFebruary 18, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Cairo University
Enrollment
30
Locations
1
Primary Endpoint
Biodex balance system
Status
Completed
Last Updated
last year

Overview

Brief Summary

To determine the efficacy of high frequency cerebellar repetitive transcranial magnetic stimulation on coordination in patients with multiple sclerosis.

Detailed Description

Forty patients with multiple sclerosis suffering from ataxia less than five in EDSS score will be recruited from the outpatient clinic at Faculty of Physical Therapy as well as Kasr Al-Ainy Multiple Sclerosis unit (KAMSU), Cairo University. The study will be applied during the remission period. Patients will be assessed by Biodex balance system, Berg balance scale, Four square step test and Nine-Hole Peg Test to investigate coordination in both equilibrium and non-equilibrium. Patient will be divided into two groups.The study group will be treated by High frequecy cerebellar repetitive transcranial magnetic stimulation besides a tailored physiotherapy program, while the control group will be treated by Sham cerebellar repetitive transcranial magnetic stimulation with a tailored physiotherapy program as well. The treatment duration for each patient will take weeks.

Registry
clinicaltrials.gov
Start Date
February 18, 2024
End Date
August 5, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hoda Zayed Abd Elraheem Mohamed

Assistant lecturer

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Clinically definite MS (relapsing, remitting and secondary progressive) patients
  • Patients who are medically stable and Free from relapses three months before
  • Ambulant patients without an assistive device and score less than 5 on the Kurtzke Expanded Disability Status Scale (EDSS)
  • Patients receiving their disease modifying drugs but no medication changing during the previous three months.
  • Patients who had MRI evidence of lesions in the cerebellum or in the cerebellar pedunculi.
  • Right handed patients.
  • Severity of ataxia range from 4 to 10 according to scale of assessment and rating ataxia (SARA).
  • Did not apply cerebellar transcranial magnetic stimulation before.

Exclusion Criteria

  • Any other neurological deficits or orthopedics abnormalities.
  • Ataxic manifestations for other cause rather than Multiple Sclerosis.
  • Other neurological manifestations (e.g. spasticity, visual loss)
  • Secondary musculoskeletal complication such as contractures or deformities. Cardiovascular, pulmonary, hepatic, renal, hemopoietic and thyroid diseases.
  • Pregnant women.
  • Addicted individuals.
  • Previous surgeries in the brain.
  • Any magnetic or metallic devices implanted (like cochlear implants) .
  • Psychotic deficits or history of epileptic seizures.

Outcomes

Primary Outcomes

Biodex balance system

Time Frame: 2 weeks after end of treatment

Change of balance and stability index from baseline to 2 weeks after the beginning of intervention (when the score decreases, this means good)

Secondary Outcomes

  • Berg balance scale(2 weeks after end of treatment)
  • Nine-Hole Peg Test (9-HPT)(2 weeks after end of treatment)
  • Four square step test (FSST)(2 weeks after end of treatment)

Study Sites (1)

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