An interventional study of navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellum in Spinocerebellar Ataxias, sponsored by Xijing Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by Xijing Hospital · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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:
Participants will:
95 studies on the registry are indexed under Spinocerebellar Ataxias; 25 are open to participants now.
This study's planned enrollment of 80 is above the median of 29 across 61 interventional studies indexed under Spinocerebellar Ataxias.
Browse Spinocerebellar Ataxias studies →Xijing Hospital is the lead sponsor of 474 studies on the registry; 158 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellum
Device: navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellum
Sham stimulation was delivered via the built-in mode of the stimulator with 10% RMT intensity.
Device: navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellum
1,800 pulses per session for unilateral cerebellum, 50-minute intersession interval, 80% resting motor threshold, total 75600 pulse number.
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
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
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
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
The instrumented gait analysis showed that step width, step length
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
TMS combined with EEG
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
Incidence and severity of side effects
Time frame: within 24 hours after the end of treatment
The change from baseline score on MMSE(Mini-mental state examination)
Assesse cognitive function (orientation, memory, attention, calculation, language ability, etc.)
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
MOCA(Montreal Cognitive Scale)
A rapid cognitive assessment tool designed to evaluate cognitive dysfunction, covering 11 assessment items across 8 cognitive domains: attention and concentration, executive function, memory, language, visuospatial skills, abstract thinking, calculation, and orientation.
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
HAMA(Hamilton anxiety scale)
Assess the severity of anxiety symptoms in patients
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
HAMD(Hamilton depression scale)
Assess the severity of depressive symptoms
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
PSQI(Pittsburgh sleep quality Index)
A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval
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
The 9-Hole Peg Test
A common fine motor test used in occupational therapy assessments to collect a baseline on fine motor skills, dexterity, hand-eye coordination, motor planning, and more
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
10-m walking test
The 10 Metre Walk Test is a performance measure used to assess walking or gait speed in meters per second over a short distance and can be employed to determine functional mobility, gait, and vestibular function
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
No study locations are listed for this record.
Start is estimated for Mar 2025; primary completion for Dec 2026, 21 months later.
Of 28 interventional studies with no phase under Spinocerebellar Ataxias, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 21 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.