Efficacy of Cerebellar Transcranial Magnetic Stimulation to Treat Hereditary Spinocerebellar Ataxias

Air Force Military Medical University of People's Liberation Army

Status

Not yet enrolling

Conditions

Spinocerebellar Ataxias

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06898645

KY20242432

Details and patient eligibility

About

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.

Full description

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).

Enrollment

80 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.