Cerebellar rTMS and Physical Therapy for Cerebellar Ataxia

Spinocerebellar Ataxias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04595578
• Other study ID #: 2017-10-166
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: October 2020
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ataxia
• Atrophy
• Cerebellar Ataxia
• Multiple System Atrophy
• Multiple System Atrophy, Cerebellar Variant (Disorder)
• Shy-Drager Syndrome
• Spinocerebellar Ataxias
• Spinocerebellar Degenerations

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Cooperative Ataxia Rating Scale (ICARS)	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.	The change of ICARS score between baseline (T0) and immediately after (T1) treatment
Secondary	Change from temporospatial parameters of gait	Gait parameters measured by GAITRite system	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.
Secondary	Change from posturography	Posturography measured by Pedoscan system	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.
Secondary	Change from Mini-Mental State Examination (MMSE)	Measurement of cognitive function	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.
Secondary	Change from Beck depression inventory (BDI)	Measurement of symptoms of depression	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.
Secondary	Change from Barthel Index for Activities of Daily Living	Measurement of 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.
Secondary	Change from International Cooperative Ataxia Rating Scale (ICARS)	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.	The clinical scales were evaluated by blinded raters at baseline (T0) and 4 weeks after (T2), and 12 weeks (T3) after intervention.