Cerebellar rTMS and Physical Therapy for Cerebellar Ataxia

NCT04595578 | Completed

• 1 other identifier: 2017-10-166
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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 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 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 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.

Study Arms (2)

Cerebellar rTMS + Physical therapy

ACTIVE COMPARATOR

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.

Device: Cerebellar repetitive transcranial magnetic stimulation

Sham stimulation + Physical therapy

SHAM COMPARATOR

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.

Device: Cerebellar repetitive transcranial magnetic stimulation

Interventions

Cerebellar repetitive transcranial magnetic stimulation DEVICE

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.

Cerebellar rTMS + Physical therapy; Sham stimulation + Physical therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Multiple System Atrophy; Spinocerebellar Ataxias

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cerebellar Ataxia; Cerebellar Diseases; Spinocerebellar Degenerations; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Ataxia; Dyskinesias; Neurologic Manifestations; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jong Hyeon Ahn

  Samsung Medical Center, Department of Neurology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 20, 2020
• Study Start: September 1, 2017
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)