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

Chongqing Medical University

Status: Active, not recruiting

Conditions: Spinocerebellar Ataxia

Treatments: Other: Transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06904716

2023-140

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Test group

Experimental group

Description:

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.

Treatment:

Other: Transcranial magnetic stimulation

Controls

No Intervention group

Description:

The healthy control group does not receive any intervention.