Clinical trial NCT06898645: Efficacy of Cerebellar Transcranial Magnetic Stimulation to Treat Hereditary Spinocerebellar Ataxias
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinocerebellar Ataxias
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomly divided into intervention group and sham stimulation group.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 1. 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.
2. 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).

Eligibility criteria: 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.

Primary outcomes:
measure: The change from baseline score on ICARS(International Cooperative Ataxia Rating Scale)
timeFrame: 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
Secondary outcomes:
measure: The change from baseline score on SARA(Scale for the Assessment and Rating of Ataxia)
timeFrame: 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: Gait analysis
timeFrame: 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: scalp electroencephalogram
timeFrame: 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: Safety evaluation measures
timeFrame: within 24 hours after the end of treatment
Other outcomes:
measure: The change from baseline score on MMSE(Mini-mental state examination)
timeFrame: 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: MOCA(Montreal Cognitive Scale)
timeFrame: 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: HAMA(Hamilton anxiety scale)
timeFrame: 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: HAMD(Hamilton depression scale)
timeFrame: 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: PSQI(Pittsburgh sleep quality Index)
timeFrame: 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: The 9-Hole Peg Test
timeFrame: 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: 10-m walking test
timeFrame: 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
Locations:
Study officials:
References: