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NCT Number: NCT04595578

Cerebellar rTMS and Physical Therapy for Cerebellar Ataxia

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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. International Cooperative Ataxia Rating Scale (ICARS)

    Time frame: 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 outcomes

  1. Change from temporospatial parameters of gait

    Time frame: 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

  2. Change from posturography

    Time frame: 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

  3. Change from Mini-Mental State Examination (MMSE)

    Time frame: 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

  4. Change from Beck depression inventory (BDI)

    Time frame: 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

  5. Change from Barthel Index for Activities of Daily Living

    Time frame: 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

  6. Change from International Cooperative Ataxia Rating Scale (ICARS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 20, 2020
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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