Efficacy of Cerebellar Transcranial Magnetic Stimulation to Treat Hereditary Spinocerebellar Ataxias

NCT ID: NCT06898645

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2027-12-31

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).

Conditions

Spinocerebellar Ataxias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

active stimulation

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

1,800 pulses per session for unilateral cerebellum, 50-minute intersession interval, 80% resting motor threshold, total 75600 pulse number.

sham stimulation

Sham stimulation was delivered via the built-in mode of the stimulator with 10% RMT intensity.

Group Type: SHAM_COMPARATOR

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

Intervention Type: DEVICE

1,800 pulses per session for unilateral cerebellum, 50-minute intersession interval, 80% resting motor threshold, total 75600 pulse number.

Interventions

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

1,800 pulses per session for unilateral cerebellum, 50-minute intersession interval, 80% resting motor threshold, total 75600 pulse number.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

KY20242432

Identifier Type: -

Identifier Source: org_study_id