About this trial
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:
1. Does navigated iTBS targeting the cerebellum improve the symptoms and clinical scale score of ataxias? 2. 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:
1. Navigated iTBS targeting the cerebellum or sham stimulation every day for 7 day, 2. Assessments were made at baseline, within 24 hours after the end of treatment, after 12 weeks, and after 24 weeks of telephone follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellum
Device1,800 pulses per session for unilateral cerebellum, 50-minute intersession interval, 80% resting motor threshold, total 75600 pulse number.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
Gait analysis
The instrumented gait analysis showed that step width, step length
scalp electroencephalogram
TMS combined with EEG
Safety evaluation measures
Incidence and severity of side effects
Other outcomes
The change from baseline score on MMSE(Mini-mental state examination)
Assesse cognitive function (orientation, memory, attention, calculation, language ability, etc.)
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.
HAMA(Hamilton anxiety scale)
Assess the severity of anxiety symptoms in patients
HAMD(Hamilton depression scale)
Assess the severity of depressive symptoms
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: