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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active stimulation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellum | Device | 1,800 pulses per session for unilateral cerebellum, 50-minute intersession interval, 80% resting motor threshold, total 75600 pulse number. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline score on MMSE(Mini-mental state examination) | Assesse cognitive function (orientation, memory, attention, calculation, language ability, etc.) | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D020754 | Spinocerebellar Ataxias |
| ID | Term |
|---|---|
| D002524 | Cerebellar Ataxia |
| D002526 | Cerebellar Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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randomly divided into intervention group and sham stimulation group.
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| Gait analysis | The instrumented gait analysis showed that step width, step length | 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 | 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 | within 24 hours after the end of treatment |
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. |
| 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 | 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 | 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 | 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 | 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 | 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 |
| D009422 |
| Nervous System Diseases |
| D013132 | Spinocerebellar Degenerations |
| D013118 | Spinal Cord Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D001259 | Ataxia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |