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Cerebellar rTMS in Patients With Multiple Sclerosis

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	20 Years - 45 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06265922
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Cairo University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Patients With Multiple Sclerosis

Additional Details

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.

Arms & Interventions

Arms

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

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

Interventions

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.

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Hoda Zayed

[email protected]

+201111052808

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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