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Cerebellar rTMS and Physical Therapy for Cerebellar Ataxia

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cerebellar repetitive transcranial magnetic stimulation
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple System Atrophy, Cerebellar Variant (Disorder)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Cerebellar rTMS + Physical therapy

Sham stimulation + Physical therapy

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from temporospatial parameters of gait
Gait parameters measured by GAITRite system
Change from posturography
Posturography measured by Pedoscan system
Change from Mini-Mental State Examination (MMSE)
Measurement of cognitive function
Change from Beck depression inventory (BDI)
Measurement of symptoms of depression
Change from Barthel Index for Activities of Daily Living
Measurement of activities of daily living
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.

Full Information

First Posted
October 7, 2020
Last Updated
October 14, 2020
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04595578
Brief Title
Cerebellar rTMS and Physical Therapy for Cerebellar Ataxia
Official Title
Effect of Repetitive Transcranial Magnetic Stimulation With Intensive Physical Therapy in Cerebellar Ataxia: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
March 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple System Atrophy, Cerebellar Variant (Disorder), Spinocerebellar Ataxias

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cerebellar rTMS + Physical therapy
Arm Type
Active Comparator
Arm 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.
Arm Title
Sham stimulation + Physical therapy
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Cerebellar repetitive transcranial magnetic stimulation
Intervention 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.
Primary Outcome Measure Information:
Title
International Cooperative Ataxia Rating Scale (ICARS)
Description
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.
Time Frame
The change of ICARS score between baseline (T0) and immediately after (T1) treatment
Secondary Outcome Measure Information:
Title
Change from temporospatial parameters of gait
Description
Gait parameters measured by GAITRite system
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.
Title
Change from posturography
Description
Posturography measured by Pedoscan system
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.
Title
Change from Mini-Mental State Examination (MMSE)
Description
Measurement of cognitive function
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.
Title
Change from Beck depression inventory (BDI)
Description
Measurement of symptoms of depression
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.
Title
Change from Barthel Index for Activities of Daily Living
Description
Measurement of 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.
Title
Change from International Cooperative Ataxia Rating Scale (ICARS)
Description
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.
Time Frame
The clinical scales were evaluated by blinded raters at baseline (T0) and 4 weeks after (T2), and 12 weeks (T3) after intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Hyeon Ahn
Organizational Affiliation
Samsung Medical Center, Department of Neurology
Official's Role
Study Director
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Cerebellar rTMS and Physical Therapy for Cerebellar Ataxia

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