Efficacy of Cerebellar Transcranial Magnetic Stimulation to Treat Hereditary Spinocerebellar Ataxias

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXijing Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: active stimulationExperimental treatment 1 intervention
Group B: sham stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

Safety evaluation measures

Incidence and severity of side effects

Time frame
within 24 hours after the end of treatment

Other outcomes

1

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
2

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
3

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
4

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

Locations

This trial has no locations.

Sponsors and contacts

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