rTMS Improves Functions in Spinocerebellar Ataxia
Primary Purpose
Transcranial Magnetic Stimulation, Spinocerebellar Ataxias
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS)
Sponsored by
About this trial
This is an interventional treatment trial for Transcranial Magnetic Stimulation focused on measuring rTMS, SCA
Eligibility Criteria
Inclusion Criteria: SCA type 3 independently walk with/without an assistive device SARA greater than 3 Exclusion Criteria: Epilepsy history Unstable blood pressure Brain Trauma Alcoholism, drug abuse, antipsychotics drug use Metallic hardware (e.g. - cochlear implants, brain stimulators or electrodes, aneurysm clips) anywhere in head. Dementia, depression
Sites / Locations
- Changhua christian hospitalRecruiting
- Changhua christian hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rTMS with 10 Hz
Arm Description
6 times/per week for 2 weeks, total 12 times rTMS.
Outcomes
Primary Outcome Measures
Changes of International Cooperative Ataxia Rating Scale
International Cooperative Ataxia Rating Scale (ICARS): quantify the level of impairment as a result of ataxia as related to hereditary ataxias. Disorders rated as subscales within the ICARS are: Postural and gait disturbances, Limb Ataxia, Dysarthria, and Oculomotor disorders.It translates the symptomatology of cerebellar ataxia into a scoring system out of 100.
Changes of SARA
Scale for the Assessment and Rating of Ataxia (SARA): a tool for assessing ataxia. It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).
Changes of Berg Balance Scale
Berg Balance Scale (BBS): a widely used assessment to determine a person's balance abilities. The test contains 14 simple tasks, scoring ranges from 0 to 56. The lower your score, the more at risk you are for losing your balance. The entire process takes about 20 minutes to complete.
Changes of Timed up and go
Timed up and go (TUG): Patients wear their regular footwear and can use a walking aid, if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor.
Changes of Center of pressure trajectory
Center of pressure (COP): he trajectory of the COP, commonly known as a stabilogram, during static balance is frequently used to measure postural control. When standing still on a force platform, the COP is thought to be an indicator of the motor mechanisms involved in maintaining balance with opened-eyes or closed-eyes. Two trials for each condition were performed within 5 minutes.
Changes of Kinematic of Gait
The joint angles of hip, knee, ankle are collected during walking in a 10 meters walkway.
Changes of Electromyography of Gait
A wireless surface Electromyography (EMG) is used to collect lower extremities muscle activation signals during walking in a walkway.
Secondary Outcome Measures
Concentration of Neurofilament
neurofilament proteins is the biomarkers of axonal damage in diseases affecting the central nervous system
Changes of Mini-mental state examination
The mini-mental state examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment. In this study, it is used to rule out subjects who might have dementia.
Full Information
NCT ID
NCT05973019
First Posted
July 25, 2023
Last Updated
October 16, 2023
Sponsor
Changhua Christian Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05973019
Brief Title
rTMS Improves Functions in Spinocerebellar Ataxia
Official Title
Repetitive Transcranial Magnetic Stimulation Improves Functional Performance in Spinocerebellar Ataxia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhua Christian Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Spinocerebellar ataxia (SCA) is a group of inherited brain disorders. SCA often result in poor limb coordination. This study aims to discover the effects of repeated transcranial magnetic stimulation (rTMS) on balance & gait in SCA. The hypothesis of this study is that rTMS might improve SCA limb functional performance.
Detailed Description
rTMS has been shown that improves walking speed and balance performance, however, the optimal treatment protocols have not been approved. Past studies used different frequencies 1 Hz, 5 Hz and 10 Hz to improve functional performance. The results might be affected by the types of SCA. In this study, we will focus on the SCA type 3 to assess the effects on high frequency (10 Hz) of rTMS intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcranial Magnetic Stimulation, Spinocerebellar Ataxias
Keywords
rTMS, SCA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All subjects receive 12 times rTMS intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rTMS with 10 Hz
Arm Type
Experimental
Arm Description
6 times/per week for 2 weeks, total 12 times rTMS.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Description
6 times/per week for 2 weeks, total 12 times rTMS with 10 Hz.
Primary Outcome Measure Information:
Title
Changes of International Cooperative Ataxia Rating Scale
Description
International Cooperative Ataxia Rating Scale (ICARS): quantify the level of impairment as a result of ataxia as related to hereditary ataxias. Disorders rated as subscales within the ICARS are: Postural and gait disturbances, Limb Ataxia, Dysarthria, and Oculomotor disorders.It translates the symptomatology of cerebellar ataxia into a scoring system out of 100.
Time Frame
Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Title
Changes of SARA
Description
Scale for the Assessment and Rating of Ataxia (SARA): a tool for assessing ataxia. It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).
Time Frame
Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Title
Changes of Berg Balance Scale
Description
Berg Balance Scale (BBS): a widely used assessment to determine a person's balance abilities. The test contains 14 simple tasks, scoring ranges from 0 to 56. The lower your score, the more at risk you are for losing your balance. The entire process takes about 20 minutes to complete.
Time Frame
Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Title
Changes of Timed up and go
Description
Timed up and go (TUG): Patients wear their regular footwear and can use a walking aid, if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor.
Time Frame
Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Title
Changes of Center of pressure trajectory
Description
Center of pressure (COP): he trajectory of the COP, commonly known as a stabilogram, during static balance is frequently used to measure postural control. When standing still on a force platform, the COP is thought to be an indicator of the motor mechanisms involved in maintaining balance with opened-eyes or closed-eyes. Two trials for each condition were performed within 5 minutes.
Time Frame
Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Title
Changes of Kinematic of Gait
Description
The joint angles of hip, knee, ankle are collected during walking in a 10 meters walkway.
Time Frame
Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Title
Changes of Electromyography of Gait
Description
A wireless surface Electromyography (EMG) is used to collect lower extremities muscle activation signals during walking in a walkway.
Time Frame
Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Secondary Outcome Measure Information:
Title
Concentration of Neurofilament
Description
neurofilament proteins is the biomarkers of axonal damage in diseases affecting the central nervous system
Time Frame
Baseline (T0), 12 days after first rTMS intervention (T2)
Title
Changes of Mini-mental state examination
Description
The mini-mental state examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment. In this study, it is used to rule out subjects who might have dementia.
Time Frame
Baseline (T0)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
SCA type 3
independently walk with/without an assistive device
SARA greater than 3
Exclusion Criteria:
Epilepsy history
Unstable blood pressure
Brain Trauma
Alcoholism, drug abuse, antipsychotics drug use
Metallic hardware (e.g. - cochlear implants, brain stimulators or electrodes, aneurysm clips) anywhere in head.
Dementia, depression
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sen Yung Liu, MD
Phone
88647238595
Ext
7427
Email
88925@cch.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sen Yung Liu, MD
Organizational Affiliation
Changhua Christian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhua christian hospital
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Changhua christian hospital
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sen Yung Liu, MD
Phone
88647238595
Ext
7022
Email
88925@cch.org.tw
12. IPD Sharing Statement
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rTMS Improves Functions in Spinocerebellar Ataxia
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