Effect of Repetitive Transcranial Magnetic Stimulation With Intensive Physical Therapy in Cerebellar Ataxia: A Pilot Study

Samsung Medical Center1 site in 1 country34 target enrollmentSeptember 1, 2017

ConditionsMultiple System Atrophy, Cerebellar Variant (Disorder)Spinocerebellar Ataxias

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Multiple System Atrophy, Cerebellar Variant (Disorder)
Sponsor: Samsung Medical Center
Enrollment: 34
Locations: 1
Primary Endpoint: International Cooperative Ataxia Rating Scale (ICARS)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The present study investigated the efficacy and safety of combination treatment of repetitive transcranial magnetic stimulation (rTMS) and physical therapy (PT) in patients with cerebellar variant of multiple system atrophy (MSA-C) and spinocerebellar ataxia.

Registry

clinicaltrials.gov

Start Date

September 1, 2017

End Date

March 31, 2018

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Principal Investigator

Jinyoung Youn

Associate Professor

Samsung Medical Center

Eligibility Criteria

Inclusion Criteria

•The patients with probable MSA-C and spinocerebellar ataxia (SCA)
•cerebellar ataxia as main clinical presenting feature and able to walk independently without walking devices
•aged over 20
•presence of cerebellar atrophy proven by brain MRI.

Exclusion Criteria

•secondary cerebellar ataxia
•peripheral neuropathy, radiculopathy, or decreased visual acuity that can cause peripheral ataxia
•musculoskeletal disease affecting gait or balance
•other neurologic symptoms, including symptomatic parkinsonism (two or more rigidity and/or bradykinesia scores in one limb by Unified Parkinson's disease Rating Scale part 3) or spasticity (20)
•psychiatric symptoms requiring medication or with cognitive decline (Mini-mental state examination \[MMSE\] \< 20)
•taking any sedative medications or anti-parkinsonian medications such as benzodiazepine, levodopa or dopamine agonist
•history of seizure or metallic brain implants; (8) cardiopulmonary diseases causing dyspnea during exercise.

Outcomes

Primary Outcomes

International Cooperative Ataxia Rating Scale (ICARS)

Time Frame: The change of ICARS score between baseline (T0) and immediately after (T1) treatment

The scale is scored out of 100 with 19 items and 4 subscales of postural and gait disturbances, limb ataxia, dysarthria, and oculomotor disorders. Higher scores indicate higher levels of impairment.

Secondary Outcomes

Change from Mini-Mental State Examination (MMSE)(The clinical scales were evaluated by blinded raters at baseline (T0) and immediately after (T1), 4 weeks after (T2), and 12 weeks (T3) after intervention.)
Change from Beck depression inventory (BDI)(The clinical scales were evaluated by blinded raters at baseline (T0) and immediately after (T1), 4 weeks after (T2), and 12 weeks (T3) after intervention.)
Change from temporospatial parameters of gait(The clinical scales were evaluated by blinded raters at baseline (T0) and immediately after (T1), 4 weeks after (T2), and 12 weeks (T3) after intervention.)
Change from Barthel Index for Activities of Daily Living(The clinical scales were evaluated by blinded raters at baseline (T0) and immediately after (T1), 4 weeks after (T2), and 12 weeks (T3) after intervention.)
Change from posturography(The clinical scales were evaluated by blinded raters at baseline (T0) and immediately after (T1), 4 weeks after (T2), and 12 weeks (T3) after intervention.)
Change from International Cooperative Ataxia Rating Scale (ICARS)(The clinical scales were evaluated by blinded raters at baseline (T0) and 4 weeks after (T2), and 12 weeks (T3) after intervention.)