Cerebellar rTMS in Patients With Multiple Sclerosis

February 11, 2024 updated by: Hoda Zayed Abd Elraheem Mohamed, Cairo University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High frequency cerebellar repetitive transcranial magnetic stimulation
Twenty patients will be treated by high frequency repetitive transcranial magnetic stimulation (Hf-rTMS) targeting the cerebellum beside a tailored physical therapy program designed for the ataxic manifestation The protocol of rTMS included 6 sessions over 2 weeks. MagPro R20 device will be applied over midline of cerebellum using circular coil. Ten repetition rate in 40 trains with one inter train interval will be applied two times within the same session, 5 minutes rest in between Tailored physiotherapy program for ataxic manifestation will be applied for 10 days in the same 2 weeks
Device: High frequency repetitive transcranial magnetic stimulation
High frequency repetitive transcranial magnetic stimulation will be applied over mid line of cerebellum using circular coil. Ten repetition rate (frequency) in 40 trains with one intertrain interval will be applied for three times a week for two weeks.
Other Names:
  • Hf-rTMS
Sham Comparator: Sham cerebellar repetitive transcranial magnetic stimulation

Twenty patients will be treated by sham cerebellar rTMS with the same parameters, same duration 6 sessions over 2 weeks except the coil will not be on the middle of the cerebellum instead it will be perpendicular away from it.

But the program of physiotherapy is the same
Device: Sham repetitive transcranial magnetic stimulation
Sham repetitive transcranial magnetic stimulation will be applied Perpendicular away from the cerebellum using the same circular coil. The same parameters will be used with the same duration also numbers of sessions are the same like the active comparator group to assure the patients blindness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 weeks after end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg balance scale
Time Frame: 2 weeks after end of treatment
Change of the balance score from baseline to two weeks after the beginning of the intervention
2 weeks after end of treatment
Nine-Hole Peg Test (9-HPT)
Time Frame: 2 weeks after end of treatment
Change of manual dexterity of both the dominant and non dominant hand from baseline to 2 weeks after the beginning of intervention
2 weeks after end of treatment
Four square step test (FSST)
Time Frame: 2 weeks after end of treatment
Change of dynamic balance and coordination from baseline to 2 weeks after the beginning of intervention
2 weeks after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 18, 2024

Primary Completion (Estimated)

April 18, 2024

Study Completion (Estimated)

June 2, 2024

Study Registration Dates

First Submitted

February 11, 2024

First Submitted That Met QC Criteria

February 11, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 11, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/003937

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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