Clinical trial NCT04595578: Cerebellar rTMS and Physical Therapy for Cerebellar Ataxia
Official title: Effect of Repetitive Transcranial Magnetic Stimulation With Intensive Physical Therapy in Cerebellar Ataxia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple System Atrophy, Cerebellar Variant (Disorder)
Spinocerebellar Ataxias
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. secondary cerebellar ataxia
2. peripheral neuropathy, radiculopathy, or decreased visual acuity that can cause peripheral ataxia
3. musculoskeletal disease affecting gait or balance
4. 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)
5. psychiatric symptoms requiring medication or with cognitive decline (Mini-mental state examination \[MMSE\] \< 20)
6. taking any sedative medications or anti-parkinsonian medications such as benzodiazepine, levodopa or dopamine agonist
7. history of seizure or metallic brain implants; (8) cardiopulmonary diseases causing dyspnea during exercise.

Primary outcomes:
measure: International Cooperative Ataxia Rating Scale (ICARS)
timeFrame: The change of ICARS score between baseline (T0) and immediately after (T1) treatment
Secondary outcomes:
measure: Change from temporospatial parameters of gait
timeFrame: 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.
measure: Change from posturography
timeFrame: 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.
measure: Change from Mini-Mental State Examination (MMSE)
timeFrame: 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.
measure: Change from Beck depression inventory (BDI)
timeFrame: 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.
measure: Change from Barthel Index for Activities of Daily Living
timeFrame: 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.
measure: Change from International Cooperative Ataxia Rating Scale (ICARS)
timeFrame: The clinical scales were evaluated by blinded raters at baseline (T0) and 4 weeks after (T2), and 12 weeks (T3) after intervention.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Department of Neurology
name: Jong Hyeon Ahn
role: STUDY_DIRECTOR
References: