Cerebellar rTMS and Physical Therapy for Cerebellar Ataxia

Samsung Medical Center

Status: Completed

Conditions: Spinocerebellar Ataxias; Multiple System Atrophy, Cerebellar Variant (Disorder)

Treatments: Device: Cerebellar repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04595578

2017-10-166

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups

Cerebellar rTMS + Physical therapy

Active Comparator group

Description:

rTMS was delivered on the scalp for over 2 cm under the inion, which is the scalp over the cerebellum area, using a double-cone coil connected to a Magstim Rapid2® stimulator with two Booster Modules (Magstim, Spring Gardens, Wales, UK) in accordance with safety recommendations. Stimulation was delivered to the cerebellum at 10 Hz with 90% of the mean resting motor threshold intensity for 5 seconds at 55 second intervals to deliver 1000 pulses in 20 minutes. Immediately after rTMS, the combination treatment group received balance and gait training by a physical therapist for 30 minutes/day and underwent aerobic exercise using a stationary bicycle at moderate intensity (12 to 14 rating of perceived exertion) for 30 minutes/day and 5 days/week for two weeks. In the control group, no participants received physical therapy or rTMS for two weeks.

Treatment:

Device: Cerebellar repetitive transcranial magnetic stimulation

Sham stimulation + Physical therapy

Sham Comparator group

Description:

Sham stimulation was delivered on the scalp for over 2 cm under the inion, which is the scalp over the cerebellum area, using a double-cone coil connected to a Magstim Rapid2® stimulator. Sham stimulation was delivered to the cerebellum for 5 seconds at 55 second intervals in 20 minutes. Immediately after rTMS, the combination treatment group received balance and gait training by a physical therapist for 30 minutes/day and underwent aerobic exercise using a stationary bicycle at moderate intensity (12 to 14 rating of perceived exertion) for 30 minutes/day and 5 days/week for two weeks. In the control group, no participants received physical therapy or rTMS for two weeks.

Treatment:

Device: Cerebellar repetitive transcranial magnetic stimulation