Cerebellar RTMS in Patients with Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-18

Study Completion Date

2024-08-05

Brief Summary

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

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Detailed Description

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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.

Conditions

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Patients with Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Participant masking as patients will be divided into two groups High frequecy cerebellar repetitive transcranial magnetic stimulation and Sham repetitive transcranial magnetic stimulation by placing the coil in perpendicular way away from the cerebellum.

Care provider masking as the physical therapist treating patients will be blind from the application of repetitive transcranial magnetic stimulation

Study Groups

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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

Group Type ACTIVE_COMPARATOR

High frequency repetitive transcranial magnetic stimulation

Intervention Type 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.

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

Group Type SHAM_COMPARATOR

Sham repetitive transcranial magnetic stimulation

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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Hf-rTMS

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No