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Completed

NCT Number: NCT06265922

Cerebellar RTMS in Patients with Multiple Sclerosis

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

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of physical therapy, Cairo University

Giza, Dokki, 12612, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High frequency repetitive transcranial magnetic stimulation

Device

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 repetitive transcranial magnetic stimulation

Device

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

Primary outcomes

  1. 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

  1. 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 ( the scale consists of 14 item. Minimum score for each item is 0 and maximum score is 4, to record the patient the summation of the 14 item is counted. And if the score is increasing this means good)

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 20, 2024
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.