Efficacy of Cerebellar Transcranial Magnetic Stimulation to Treat Hereditary Spinocerebellar Ataxias

NCT06898645 | Not Yet Recruiting DMC

• 1 other identifier: KY20242432
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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. 1.Does navigated iTBS targeting the cerebellum improve the symptoms and clinical scale score of ataxias?
2. 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.
3. 3.Navigated iTBS targeting the cerebellum or sham stimulation every day for 7 day,
4. 4.Assessments were made at baseline, within 24 hours after the end of treatment, after 12 weeks, and after 24 weeks of telephone follow-up.

Conditions

Spinocerebellar Ataxias

Outcome Measures

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

  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 (4)

• The change from baseline score on SARA(Scale for the Assessment and Rating of 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

• Gait analysis

  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

  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

  within 24 hours after the end of treatment

Other Outcomes (7)

• The change from baseline score on MMSE(Mini-mental state examination)

  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)

  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)

  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

Study Arms (2)

active stimulation

EXPERIMENTAL

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

Device: 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.

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

Interventions

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.

active stimulation; sham stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

MeSH Terms

Conditions

Spinocerebellar Ataxias

Condition Hierarchy (Ancestors)

Cerebellar Ataxia; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinocerebellar Degenerations; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Ataxia; Dyskinesias; Neurologic Manifestations; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomly divided into intervention group and sham stimulation group.

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: March 27, 2025
• Study Start: March 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 27, 2025

Record last verified: 2025-01