Cerebellar rTMS and Physical Therapy for Cerebellar Ataxia

Not Applicable

Completed

• Conditions: Spinocerebellar Ataxias; Multiple System Atrophy, Cerebellar Variant (Disorder)
• Interventions: Device: Cerebellar repetitive transcranial magnetic stimulation

• Registration Number: NCT04595578
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2018-03-31
• Study Completion: 2018-03-31
• Status Verified: 2020-10
• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-14
• Last Update Submitted: 2020-10-14
• Study First Posted: 2020-10-20
• Last Update Posted: 2020-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cerebellar rTMS + Physical therapy	Cerebellar repetitive transcranial magnetic stimulation	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.
Sham stimulation + Physical therapy	Cerebellar repetitive transcranial magnetic stimulation	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.

Primary Outcome Measures

Name	Time	Method
International Cooperative Ataxia Rating Scale (ICARS)	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 Outcome Measures

Name	Time	Method
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.	Measurement of cognitive function
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.	Measurement of symptoms of depression
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.	Gait parameters measured by GAITRite system
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.	Measurement of activities of daily living
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.	Posturography measured by Pedoscan system
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.	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.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of