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Cerebellar rTMS and Physical Therapy for Cerebellar Ataxia

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ClinicalTrials.gov Identifier: NCT04595578
Recruitment Status : Completed
First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Jinyoung Youn, Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE October 7, 2020
First Posted Date  ICMJE October 20, 2020
Last Update Posted Date October 20, 2020
Actual Study Start Date  ICMJE September 1, 2017
Actual Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cerebellar rTMS and Physical Therapy for Cerebellar Ataxia
Official Title  ICMJE Effect of Repetitive Transcranial Magnetic Stimulation With Intensive Physical Therapy in Cerebellar Ataxia: A Pilot Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple System Atrophy, Cerebellar Variant (Disorder)
  • Spinocerebellar Ataxias
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: Cerebellar rTMS + Physical therapy
    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.
    Intervention: Device: Cerebellar repetitive transcranial magnetic stimulation
  • Sham Comparator: Sham stimulation + Physical therapy
    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: Device: Cerebellar repetitive transcranial magnetic stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2020)
34
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 31, 2018
Actual Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04595578
Other Study ID Numbers  ICMJE 2017-10-166
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jinyoung Youn, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jong Hyeon Ahn Samsung Medical Center, Department of Neurology
PRS Account Samsung Medical Center
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP