Transcranial Magnetic StimulationNCT05973019
rTMS Improves Functions in Spinocerebellar Ataxia
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Transcranial Magnetic Stimulation and Spinocerebellar Ataxias, run by Changhua Christian Hospital at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Transcranial Magnetic Stimulation, Spinocerebellar Ataxias
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Sep 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SCA type 3
- independently walk with/without an assistive device
- SARA greater than 3
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
Changhua christian hospital
Changhua, 500
- Recruiting
Changhua christian hospital
Changhua, 500
Sen Yung Liu, MD, 88647238595 ext. 7022, 88925@cch.org.tw
About this study
Official title: Repetitive Transcranial Magnetic Stimulation Improves Functional Performance in Spinocerebellar Ataxia
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.
Read the 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.
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Keywords
- rTMS, SCA
- Medical subject headings
- Spinocerebellar Ataxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
6 times/per week for 2 weeks, total 12 times rTMS with 10 Hz.
| Study group | Role | What they receive |
|---|---|---|
| rTMS with 10 Hz | Experimental | 6 times/per week for 2 weeks, total 12 times rTMS. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
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).
Measured: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
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.
Measured: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
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.
Measured: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
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.
Measured: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Changes of Kinematic of Gait
The joint angles of hip, knee, ankle are collected during walking in a 10 meters walkway.
Measured: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Changes of Electromyography of Gait
A wireless surface Electromyography (EMG) is used to collect lower extremities muscle activation signals during walking in a walkway.
Measured: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Secondary outcomes (2)
Concentration of Neurofilament
neurofilament proteins is the biomarkers of axonal damage in diseases affecting the central nervous system
Measured: Baseline (T0), 12 days after first rTMS intervention (T2)
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.
Measured: Baseline (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Sep 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Magnetic StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects receive 12 times rTMS intervention
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sen-yung Liu, Changhua Christian Hospital
- Investigators
- Sen Yung Liu, MD, Principal investigator, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973019
- Sponsor's protocol ID
- 230425
- Status last verified
- Oct 2023
- First submitted
- 25 Jul 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation Improves Functional Performance in Spinocerebellar Ataxia
- ClinicalTrials.gov ID
- NCT05973019
- Acronym / sponsor ID
- 230425
- Keywords
- rTMS, SCA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects receive 12 times rTMS intervention
| Arm | Type | Receives |
|---|---|---|
| rTMS with 10 Hz | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)6 times/per week for 2 weeks, total 12 times rTMS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- SCA type 3
- independently walk with/without an assistive device
- SARA greater than 3
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)6 times/per week for 2 weeks, total 12 times rTMS with 10 Hz. | Device | rTMS with 10 Hz |
Primary outcome
Changes of International Cooperative Ataxia Rating Scale
Time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
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
Time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
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
Time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
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
Time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
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
Time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
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
Time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
The joint angles of hip, knee, ankle are collected during walking in a 10 meters walkway.
Changes of Electromyography of Gait
Time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
A wireless surface Electromyography (EMG) is used to collect lower extremities muscle activation signals during walking in a walkway.
2 secondary outcomes
Concentration of Neurofilament
Time frame: Baseline (T0), 12 days after first rTMS intervention (T2)
Changes of Mini-mental state examination
Time frame: Baseline (T0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sen Yung Liu, MD principal investigator
Changhua Christian Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Transcranial Magnetic Stimulation and Spinocerebellar Ataxias, run by Changhua Christian Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sen Yung Liu, MD (88647238595 ext. 7427, 88925@cch.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of International Cooperative Ataxia Rating Scale (time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023; AzTrials last refreshed its copy on 3 Nov 2026.