The Study of Transcranial Magnetic Stimulation in the Regulation of Spinocerebellar Ataxia

NCT ID: NCT06904716

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-05-01

Brief Summary

Spinocerebellar ataxia (SCA) is a group of hereditary neurological diseases caused by gene mutations leading to degenerative changes in the cerebellum, brainstem, and spinal cord. A key pathogenic mechanism of SCA is the repeated expansion of cytosine - adenine - guanine (CAG) trinucleotides in the coding region of specific genes. These repeated expansions are translated into abnormally large polyglutamine (PolyQ) tracts in proteins. These polyglutamine (PolyQ) tracts can cause changes in the excitability of the cerebral cortex in SCA patients. Quantitative electroencephalogram analysis (qEEG) is a modern type of electroencephalogram analysis that uses complex mathematical algorithms to process, transform, and analyze EEG signals, bringing new technologies for EEG signal feature extraction: specific frequency band and signal complexity analysis, connectivity analysis, and network analysis. It is sensitive to early neurodegenerative lesions. Using spectral analysis, nonlinear dynamics analysis, and functional connectivity analysis, we can explore the changes in cortical excitability and abnormal brain networks in SCA patients. Currently, the exploration of the quantitative electroencephalogram characteristics of SCA patients is still insufficient.

Conditions

Spinocerebellar Ataxia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test group

Perform low-frequency Transcranial Magnetic Stimulation (TMS) on the left and right cerebellar hemispheres and the vermis of the cerebellum, twice a day for a total of 7 days.

Group Type: EXPERIMENTAL

Transcranial magnetic stimulation

Intervention Type: OTHER

Repetitive transcranial magnetic stimulation

Controls

The healthy control group does not receive any intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Transcranial magnetic stimulation

Repetitive transcranial magnetic stimulation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Spinocerebellar ataxia patients confirmed through genetic testing

2. Patient aged 18-75

3. Patients who can walk independently (with the aid of a cane/walker) without assistance from others.

4. The SARA score exceeds 3.

Exclusion Criteria

1. Patients with unstable neurological disorders or accompanying medical conditions (such as stroke, arthritis, etc.)

2. Patients with significantly abnormal clinical indicators identified during screening

3. Patients concurrently participating in another clinical study

4. Patients with untreated intracranial hypertension, depression, dementia, or psychiatric disorders

5. Patients with severe heart disease

6. Patients who are wheelchair users

7. pregnant woman

8. Patients who cannot establish their identity or have limited legal capacity

9. Patients with contraindications for rTMS, including metallic objects in the head, history of neurosurgery, ferromagnetic bioimplants, metal coatings, history of seizures, autism, current use of protease inhibitors or other medications that may increase the risk of rTMS-induced seizures.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Fei Xiao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the First Affiliatted Hospital of Chongqing medical Uiversity

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

2023-140

Identifier Type: -

Identifier Source: org_study_id