Cerebellar RTMS in Patients with Multiple Sclerosis

Cairo University (CU)

Status: Completed

Conditions: Patients with Multiple Sclerosis

Treatments: Device: Sham repetitive transcranial magnetic stimulation; Device: High frequency repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06265922

P.T.REC/012/003937

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

High frequency cerebellar repetitive transcranial magnetic stimulation

Active Comparator group

Description:

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

Treatment:

Device: High frequency repetitive transcranial magnetic stimulation

Sham cerebellar repetitive transcranial magnetic stimulation

Sham Comparator group

Description:

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

Treatment:

Device: Sham repetitive transcranial magnetic stimulation