Spinocerebellar AtaxiaNCT06904716
The Study of Transcranial Magnetic Stimulation in the Regulation of Spinocerebellar Ataxia
A study testing Transcranial magnetic stimulation in people with Spinocerebellar Ataxia, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
Spinocerebellar ataxia (SCA) is a group of hereditary neurological diseases caused by gene mutations leading to degenerative changes in the cerebellum, brainstem, and spinal cord. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinocerebellar Ataxia
- What is being tested?
- Transcranial magnetic stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 1 May 2025
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Spinocerebellar ataxia patients confirmed through genetic testing
- Patient aged 18-75
- Patients who can walk independently (with the aid of a cane/walker) without assistance from others.
- The SARA score exceeds 3.
Who cannot join
- Patients with unstable neurological disorders or accompanying medical conditions (such as stroke, arthritis, etc.)
- Patients with significantly abnormal clinical indicators identified during screening
- Patients concurrently participating in another clinical study
- Patients with untreated intracranial hypertension, depression, dementia, or psychiatric disorders
- Patients with severe heart disease
- Patients who are wheelchair users
Show all 9Show fewer
- pregnant woman
- Patients who cannot establish their identity or have limited legal capacity
- Patients with contraindications for rTMS, including metallic objects in the head, history of neurosurgery, ferromagnetic bioimplants, metal coatings, history of seizures, autism, current use of protease inhibitors or other medications that may increase the risk of rTMS-induced seizures.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliatted Hospital of Chongqing medical Uiversity
Chongqing, Chongqing Municipality, 400042
About this study
Spinocerebellar ataxia (SCA) is a group of hereditary neurological diseases caused by gene mutations leading to degenerative changes in the cerebellum, brainstem, and spinal cord. A key pathogenic mechanism of SCA is the repeated expansion of cytosine - adenine - guanine (CAG) trinucleotides in the coding region of specific genes. These repeated expansions are translated into abnormally large polyglutamine (PolyQ) tracts in proteins. These polyglutamine (PolyQ) tracts can cause changes in the excitability of the cerebral cortex in SCA patients. Quantitative electroencephalogram analysis (qEEG) is a modern type of electroencephalogram analysis that uses complex mathematical algorithms to process, transform, and analyze EEG signals, bringing new technologies for EEG signal feature extraction: specific frequency band and signal complexity analysis, connectivity analysis, and network analysis. It is sensitive to early neurodegenerative lesions. Using spectral analysis, nonlinear dynamics analysis, and functional connectivity analysis, we can explore the changes in cortical excitability and abnormal brain networks in SCA patients. Currently, the exploration of the quantitative electroencephalogram characteristics of SCA patients is still insufficient.
- Conditions
- Spinocerebellar Ataxia
- Being tested
- Transcranial magnetic stimulation
- Medical subject headings
- Spinocerebellar Ataxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationOther
Repetitive transcranial magnetic stimulation
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Perform low-frequency Transcranial Magnetic Stimulation (TMS) on the left and right cerebellar hemispheres and the vermis of the cerebellum, twice a day for a total of 7 days. Receives: Other: Transcranial magnetic stimulation |
| Controls | No intervention | The healthy control group does not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale for the assessment and rating of ataxia
The Scale for the Assessment and Rating of Ataxia (SARA) is a clinical tool used to assess the severity of ataxia. The total score range of the SARA scale is 0 to 40 points, with higher scores indicating more severe ataxia symptoms.
Measured: Baseline and one week post-baseline (after treatment)
Resting - state electroencephalogram
Use electroencephalogram (EEG) to collect the electroencephalogram data of participants with their eyes closed and in a waking state.Using spectral analysis, nonlinear dynamics analysis, and functional connectivity analysis, we can explore the changes in cortical excitability and abnormal brain networks in SCA patients.
Measured: baseline and one week post-baseline (after treatment)
Transcranial Magnetic Stimulation - Electroencephalogram（TMS-EEG）
Transcranial magnetic stimulation is utilized to stimulate the brain, and then EEG data is immediately collected from participants using EEG to collect closed-eye, awake EEG data.Using time-frequency analysis, nonlinear dynamics analysis, and functional connectivity analysis, we can explore the changes in cortical excitability and abnormal brain networks in SCA patients.
Measured: Baseline and one week post-baseline (after treatment)
Secondary outcomes (4)
The International Cooperative Ataxia Rating Scale (ICARS)
The International Cooperative Ataxia Rating Scale (ICARS) is a widely used clinical tool designed to assess the severity of ataxia, particularly in patients with cerebellar disorders. The total score range of the ICARS scale is 0 to 100 points, with higher scores indicating more severe ataxia symptoms.
Measured: Baseline and one week post-baseline (after treatment)
The Neurological Examination Score for the assessment of Spinocerebellar Ataxias (NESSCA)
The Neurological Examination Score for the Assessment of Spinocerebellar Ataxias (NESSCA) is a clinical tool specifically designed to evaluate the severity of spinocerebellar ataxias (SCAs).The total score range of the NESSCA scale is 0 to 60 points, with higher scores indicating more severe ataxia symptoms.
Measured: Baseline and one week post-baseline (after treatment)
The EQ Visual Analogue Scale
The EQ Visual Analogue Scale (EQ-VAS) is a component of the EuroQol Five Dimensions Questionnaire (EQ-5D) used to assess a patient's subjective perception of their overall health.The EQ-VAS ranges from 0 to 100. 0: Represents "the worst imaginable health state." 100: Represents "the worst imaginable health state." High scores (closer to 100): Indicate that the patient perceives their health as very good.Low scores (closer to 0): Indicate that the patient perceives their health as very poor.
Measured: Baseline and one week post-baseline (after treatment)
Gait analysis
The researchers use gait sensors to collect gait data
Measured: Baseline and one week post-baseline (after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 May 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinocerebellar AtaxiaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Xiao, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904716
- Sponsor's protocol ID
- 2023-140
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: With the consent of both researchers and participants, the original data can be obtained by contacting with the corresponding member.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Transcranial Magnetic Stimulation in the Regulation of Spinocerebellar Ataxia
- ClinicalTrials.gov ID
- NCT06904716
- Acronym / sponsor ID
- 2023-140
- Conditions
- Spinocerebellar Ataxia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 1 Apr 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 group of hereditary neurological diseases caused by gene mutations leading to degenerative changes in the cerebellum, brainstem, and spinal cord. A key pathogenic mechanism of SCA is the repeated expansion of cytosine - adenine - guanine (CAG) trinucleotides in the coding region of specific genes. These repeated expansions are translated into abnormally large polyglutamine (PolyQ) tracts in proteins. These polyglutamine (PolyQ) tracts can cause changes in the excitability of the cerebral cortex in SCA patients. Quantitative electroencephalogram analysis (qEEG) is a modern type of electroencephalogram analysis that uses complex mathematical algorithms to process, transform, and analyze EEG signals, bringing new technologies for EEG signal feature extraction: specific frequency band and signal complexity analysis, connectivity analysis, and network analysis. It is sensitive to early neurodegenerative lesions. Using spectral analysis, nonlinear dynamics analysis, and functional connectivity analysis, we can explore the changes in cortical excitability and abnormal brain networks in SCA patients. Currently, the exploration of the quantitative electroencephalogram characteristics of SCA patients is still insufficient.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Other: Transcranial magnetic stimulationPerform low-frequency Transcranial Magnetic Stimulation (TMS) on the left and right cerebellar hemispheres and the vermis of the cerebellum, twice a day for a total of 7 days. |
| Controls | No intervention | –The healthy control group does not receive any intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Spinocerebellar ataxia patients confirmed through genetic testing
- Patient aged 18-75
- Patients who can walk independently (with the aid of a cane/walker) without assistance from others.
- The SARA score exceeds 3.
Key exclusion criteria (9 listed)
- Patients with unstable neurological disorders or accompanying medical conditions (such as stroke, arthritis, etc.)
- Patients with significantly abnormal clinical indicators identified during screening
- Patients concurrently participating in another clinical study
- Patients with untreated intracranial hypertension, depression, dementia, or psychiatric disorders
- Patients with severe heart disease
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 |
|---|---|---|
| Transcranial magnetic stimulationRepetitive transcranial magnetic stimulation | Other | Test group |
Primary outcome
Scale for the assessment and rating of ataxia
Time frame: Baseline and one week post-baseline (after treatment)
The Scale for the Assessment and Rating of Ataxia (SARA) is a clinical tool used to assess the severity of ataxia. The total score range of the SARA scale is 0 to 40 points, with higher scores indicating more severe ataxia symptoms.
Resting - state electroencephalogram
Time frame: baseline and one week post-baseline (after treatment)
Use electroencephalogram (EEG) to collect the electroencephalogram data of participants with their eyes closed and in a waking state.Using spectral analysis, nonlinear dynamics analysis, and functional connectivity analysis, we can explore the changes in cortical excitability and abnormal brain networks in SCA patients.
Transcranial Magnetic Stimulation - Electroencephalogram（TMS-EEG）
Time frame: Baseline and one week post-baseline (after treatment)
Transcranial magnetic stimulation is utilized to stimulate the brain, and then EEG data is immediately collected from participants using EEG to collect closed-eye, awake EEG data.Using time-frequency analysis, nonlinear dynamics analysis, and functional connectivity analysis, we can explore the changes in cortical excitability and abnormal brain networks in SCA patients.
4 secondary outcomes
The International Cooperative Ataxia Rating Scale (ICARS)
Time frame: Baseline and one week post-baseline (after treatment)
The Neurological Examination Score for the assessment of Spinocerebellar Ataxias (NESSCA)
Time frame: Baseline and one week post-baseline (after treatment)
The EQ Visual Analogue Scale
Time frame: Baseline and one week post-baseline (after treatment)
Gait analysis
Time frame: Baseline and one week post-baseline (after 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 1 Apr 2025.
- Individual participant dataSharing planned: Yes. With the consent of both researchers and participants, the original data can be obtained by contacting with the corresponding member.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation in people with Spinocerebellar Ataxia, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
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 9 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: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
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?
Scale for the assessment and rating of ataxia (time frame: Baseline and one week post-baseline (after treatment)). The study lists 3 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 1 Apr 2025.