Clinical trial NCT06265922: Cerebellar RTMS in Patients with Multiple Sclerosis
Official title: Effect of Cerebellar Repetitive Transcranial Magnetic Stimulation on Coordination in Patients with Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients with Multiple Sclerosis
Keywords: Patients with Multiple Sclerosis
Coordination
Transcranial magnetic stimulation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Biodex balance system
timeFrame: 2 weeks after end of treatment
Secondary outcomes:
measure: Berg balance scale
timeFrame: 2 weeks after end of treatment
measure: Nine-Hole Peg Test (9-HPT)
timeFrame: 2 weeks after end of treatment
measure: Four square step test (FSST)
timeFrame: 2 weeks after end of treatment
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy, Cairo University
state: Dokki
Study officials:
References:
citation: Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
citation: Aloizou AM, Pateraki G, Anargyros K, Siokas V, Bakirtzis C, Liampas I, Nousia A, Nasios G, Sgantzos M, Peristeri E, Dardiotis E. Transcranial magnetic stimulation (TMS) and repetitive TMS in multiple sclerosis. Rev Neurosci. 2021 Feb 25;32(7):723-736. doi: 10.1515/revneuro-2020-0140. Print 2021 Nov 25.
citation: Somaa FA, de Graaf TA, Sack AT. Transcranial Magnetic Stimulation in the Treatment of Neurological Diseases. Front Neurol. 2022 May 20;13:793253. doi: 10.3389/fneur.2022.793253. eCollection 2022.