ClinicalTrials.gov record NCT06898645

Efficacy of Cerebellar Transcranial Magnetic Stimulation to Treat Hereditary Spinocerebellar Ataxias

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

Age18 years old to 65 years old

SexAll

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized, double-masked study tests navigated cerebellar iTBS (intermittent theta-burst stimulation) against sham stimulation in adults with hereditary spinocerebellar ataxias. Treatment consists of repeated navigated iTBS sessions delivered over 7 consecutive days. Clinical scales, gait analysis, EEG and fMRI are measured at baseline, shortly after treatment, at 12 weeks, and there is a 24-week telephone follow-up; safety is also assessed.

What it is studying. Whether navigated iTBS targeting the cerebellum changes clinical ataxia scores and related measures, and to assess safety and possible neural plasticity mechanisms.

What the researchers hope to learn. To measure change from baseline on the International Cooperative Ataxia Rating Scale (primary outcome) and on the Scale for the Assessment and Rating of Ataxia (secondary), to assess gait measures and TMS‑EEG/fMRI markers, and to collect safety data (incidence and severity of side effects).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Device: navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellum

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

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

Exclusion criteria

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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).

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are assigned to either navigated intermittent theta-burst stimulation (iTBS) targeting the cerebellum or a sham stimulation. The treatment is given as many short sessions (1,800 pulses per session), with a total of 42 sessions delivered as six sessions per day over seven consecutive days (total 75,600 pulses at 80% resting motor threshold). Assessments occur at baseline, within 24 hours after the end of treatment, after 12 weeks, and a telephone follow-up at 24 weeks; tests include clinical ataxia scales (ICARS and SARA), gait analysis, scalp EEG, and brain fMRI. Safety monitoring will record side effects such as dizziness, head and neck pain, tinnitus, hearing loss, and seizures, and adverse events are collected from participants and investigators. The registry also references assessments after a possible second round of treatment; ask the study team whether a second round is planned.

How the study is structured. Interventional, randomized, parallel groups with double masking. Participants are assigned to active navigated iTBS targeting the cerebellum or to sham stimulation. The active device is delivered as multiple sessions (registry lists 42 sessions total: 1,800 pulses per session, 50-minute intersession interval, at 80% resting motor threshold) across 7 consecutive days. Assessments occur at baseline, within 24 hours after the end of treatment, at 12 weeks, and there is a 24-week telephone follow-up.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry says recruitment has not started. When is it expected to open, and can I register interest now?
No sites are listed on the registry yet. Where will the study take place?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on spinocerebellar ataxia

Clinical trials30 trials listed for spinocerebellar ataxiaEvery trial the registry lists for spinocerebellar ataxia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in spinocerebellar ataxia researchLatest monthly update: September 2026. Includes: NBP trial result. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Mar 20, 2025 (estimated)
Primary completion: Dec 31, 2026 (estimated)
Study completion: Dec 31, 2027 (estimated)
Target enrollment: 80 participants (estimated)
Last updated on registry: Mar 27, 2025
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Xijing Hospital

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins.

Terms used on this page · explanations by MedicalUpdates.ai

sham: A procedure designed to resemble the real procedure, for example the same visit and equipment, without its active part. It is the procedure equivalent of a placebo.
baseline: Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
follow-up: The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
washout: A period during which a participant stops a previous treatment before starting the study treatment, so the earlier treatment does not affect the results.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials