Spinocerebellar AtaxiasNCT06898645
Efficacy of Cerebellar Transcranial Magnetic Stimulation to Treat Hereditary Spinocerebellar Ataxias
A study testing navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellum in people with Spinocerebellar Ataxias, run by Xijing Hospital.
Trial summary
Spinocerebellar ataxia (SCA) is a type of autosomal dominant ataxia and there is currently no effective treatment. The goal of this clinical trial is to learn the efficacy of navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellum to treat hereditary spinocerebellar ataxias in adults and explore… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinocerebellar Ataxias
- What is being tested?
- navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellum
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- SCA1/2/3 patients confirmed by genetic testing
- aged 18-65 years
- presence of ataxia with a score3-20 on the Scale for the Assessment and Rating of Ataxia (SARA) and a score<60 on the International Cooperative Ataxia Rating Scale (ICARS)
- Signed informed consent by patients or their family members
Who cannot join
- Patients with serious medical conditions (such as kidney failure, liver disease) and uncontrolled high blood pressure or diabetes
- Patients with severe cognitive and behavioral disorders or mental illness
- Pregnant and lactating patients; Use other ongoing clinical medications, except for neuroprotective agents such as coenzyme Q10, butylphthalein, or cyticholine; If patients are taking valproate, riluzole and other drugs but they and their guardians have a strong desire for treatment, they can be evaluated again after washout.
- History of stroke, encephalitis and epilepsy
- Pacemakers, electronic devices and intracranial metal objects.
About this study
Official title: Clinical Study on the Effecacy of Transcranial Magnetic Stimulation of Intermittent Theta Pulse Stimulation(iTBS) Navigated Targeting the Cerebellum in the Treatment of Hereditary Spinocerebellar Ataxia
Spinocerebellar ataxia (SCA) is a type of autosomal dominant ataxia and there is currently no effective treatment. The goal of this clinical trial is to learn the efficacy of navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellum to treat hereditary spinocerebellar ataxias in adults and explore the role and neural plasticity mechanisms. It will also learn about the safety of cerebellar transcranial magnetic stimulation. The main questions it aims to answer are:
- Does navigated iTBS targeting the cerebellum improve the symptoms and clinical scale score of ataxias?
- Safety evaluation measures included treatment-related dizziness, head and neck pain, tinnitus, hearing loss, and epilepsy. Adverse reactions were reported by both subjects and investigators.
Read more
Participants will:
- Navigated iTBS targeting the cerebellum or sham stimulation every day for 7 day,
- Assessments were made at baseline, within 24 hours after the end of treatment, after 12 weeks, and after 24 weeks of telephone follow-up.
Read the detailed description
- Gait analysis, electroencephalogram (EEG), functional magnetic resonance (fMRI) and a series of clinic scales were used to further observe the therapeutic effect and reveal the possible mechanism of neuroplasticity.
- Forty-two iTBS sessions（1,800 pulses per session, 50-minute intersession interval） were delivered as 6 daily sessions over 7 consecutive days at 80% resting motor threshold (adjusted for cortical depth).
- Conditions
- Spinocerebellar Ataxias
- Being tested
- navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellum
- Medical subject headings
- Spinocerebellar Ataxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellumDevice
1,800 pulses per session for unilateral cerebellum, 50-minute intersession interval, 80% resting motor threshold, total 75600 pulse number.
| Study group | Role | What they receive |
|---|---|---|
| active stimulation | Experimental | navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellum Receives: Device: navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellum |
| sham stimulation | Sham comparator | Sham stimulation was delivered via the built-in mode of the stimulator with 10% RMT intensity. Receives: Device: navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellum |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline score on ICARS(International Cooperative Ataxia Rating Scale)
International Cooperative Ataxia Rating Scale contains four subscales on a scale of 0 to 100, with higher scores indicating more severe ataxia
Measured: at baseline, within 24 hours after the end of treatment, after 12 weeks, and within 24 hours after the end of the second round of treatment
Secondary outcomes (4)
The change from baseline score on SARA(Scale for the Assessment and Rating of Ataxia)
Scale for the Assessment and Rating of Ataxia contains eight items on a scale of 0 to 40, with higher scores indicating more severe ataxia
Measured: at baseline, within 24 hours after the end of treatment, after 12 weeks, and within 24 hours after the end of the second round of treatment
Gait analysis
The instrumented gait analysis showed that step width, step length
Measured: at baseline, within 24 hours after the end of treatment, after 12 weeks, and within 24 hours after the end of the second round of treatment
scalp electroencephalogram
TMS combined with EEG
Measured: at baseline, within 24 hours after the end of treatment, after 12 weeks, and within 24 hours after the end of the second round of treatment
Safety evaluation measures
Incidence and severity of side effects
Measured: within 24 hours after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start20 Mar 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinocerebellar AtaxiasStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomly divided into intervention group and sham stimulation group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898645
- Sponsor's protocol ID
- KY20242432
- Status last verified
- Jan 2025
- First submitted
- 4 Feb 2025
- Last updated
- 27 Mar 2025
- 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 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Effecacy of Transcranial Magnetic Stimulation of Intermittent Theta Pulse Stimulation(iTBS) Navigated Targeting the Cerebellum in the Treatment of Hereditary Spinocerebellar Ataxia
- ClinicalTrials.gov ID
- NCT06898645
- Acronym / sponsor ID
- KY20242432
- Conditions
- Spinocerebellar Ataxias
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 20 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Mar 2025 (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 type of autosomal dominant ataxia and there is currently no effective treatment. The goal of this clinical trial is to learn the efficacy of navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellum to treat hereditary spinocerebellar ataxias in adults and explore the role and neural plasticity mechanisms. It will also learn about the safety of cerebellar transcranial magnetic stimulation. The main questions it aims to answer are:
- Does navigated iTBS targeting the cerebellum improve the symptoms and clinical scale score of ataxias?
- Safety evaluation measures included treatment-related dizziness, head and neck pain, tinnitus, hearing loss, and epilepsy. Adverse reactions were reported by both subjects and investigators.
Participants will:
- Navigated iTBS targeting the cerebellum or sham stimulation every day for 7 day,
- Assessments were made at baseline, within 24 hours after the end of treatment, after 12 weeks, and after 24 weeks of telephone follow-up.
Detailed description
- Gait analysis, electroencephalogram (EEG), functional magnetic resonance (fMRI) and a series of clinic scales were used to further observe the therapeutic effect and reveal the possible mechanism of neuroplasticity.
- Forty-two iTBS sessions（1,800 pulses per session, 50-minute intersession interval） were delivered as 6 daily sessions over 7 consecutive days at 80% resting motor threshold (adjusted for cortical depth).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomly divided into intervention group and sham stimulation group.
| Arm | Type | Receives |
|---|---|---|
| active stimulation | Experimental | Device: navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellumnavigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellum |
| sham stimulation | Sham comparator | Device: navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellumSham stimulation was delivered via the built-in mode of the stimulator with 10% RMT intensity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- SCA1/2/3 patients confirmed by genetic testing
- aged 18-65 years
- presence of ataxia with a score3-20 on the Scale for the Assessment and Rating of Ataxia (SARA) and a score<60 on the International Cooperative Ataxia Rating Scale (ICARS)
- Signed informed consent by patients or their family members
Key exclusion criteria (5 listed)
- Patients with serious medical conditions (such as kidney failure, liver disease) and uncontrolled high blood pressure or diabetes
- Patients with severe cognitive and behavioral disorders or mental illness
- Pregnant and lactating patients; Use other ongoing clinical medications, except for neuroprotective agents such as coenzyme Q10, butylphthalein, or cyticholine; If patients are taking valproate, riluzole and other drugs but they and their guardians have a strong desire for treatment, they can be evaluated again after washout.
- History of stroke, encephalitis and epilepsy
- Pacemakers, electronic devices and intracranial metal objects.
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 |
|---|---|---|
| navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellum1,800 pulses per session for unilateral cerebellum, 50-minute intersession interval, 80% resting motor threshold, total 75600 pulse number. | Device | active stimulation, sham stimulation |
Primary outcome
The change from baseline score on ICARS(International Cooperative Ataxia Rating Scale)
Time frame: at baseline, within 24 hours after the end of treatment, after 12 weeks, and within 24 hours after the end of the second round of treatment
International Cooperative Ataxia Rating Scale contains four subscales on a scale of 0 to 100, with higher scores indicating more severe ataxia
4 secondary outcomes
The change from baseline score on SARA(Scale for the Assessment and Rating of Ataxia)
Time frame: at baseline, within 24 hours after the end of treatment, after 12 weeks, and within 24 hours after the end of the second round of treatment
Gait analysis
Time frame: at baseline, within 24 hours after the end of treatment, after 12 weeks, and within 24 hours after the end of the second round of treatment
scalp electroencephalogram
Time frame: at baseline, within 24 hours after the end of treatment, after 12 weeks, and within 24 hours after the end of the second round of treatment
Safety evaluation measures
Time frame: within 24 hours after the end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellum in people with Spinocerebellar Ataxias, run by Xijing Hospital.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline score on ICARS(International Cooperative Ataxia Rating Scale) (time frame: at baseline, within 24 hours after the end of treatment, after 12 weeks, and within 24 hours after the end of the second round of treatment). 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 27 Mar 2025.