Patients with Multiple Sclerosis
Conditions
Keywords
Patients with Multiple Sclerosis, Coordination, Transcranial magnetic stimulation
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.
Interventions
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.
DEVICESham 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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
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
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biodex balance system | 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
| Measure | Time frame | Description |
|---|---|---|
| Berg balance scale | 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) |
| Nine-Hole Peg Test (9-HPT) | 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 |
| Four square step test (FSST) | 2 weeks after end of treatment | Change of dynamic balance and coordination from baseline to 2 weeks after the beginning of intervention |
Countries
Egypt
Outcome results
None listed